FDA in the News

FDA Requirements for Animal Testing

2008-02-28T22:03:00.000-08:00

The FD&C Act does not specifically require the use of animals in testing cosmetics for safety, nor does the Act subject cosmetics to FDA premarket approval. However, the agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products.

It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing.

Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.

FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products. The FDA is a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.

FDA Notifies Public of Adverse Reactions Linked to Botox Use

2008-02-22T13:55:00.000-08:00

The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy.

Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

FDA News

Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA

2008-01-29T19:14:00.000-08:00

What are the criteria for the Remedial Action Exemption (RAE)?
As a medical device manufacturer, you may request an exemption from the requirement to report certain adverse events associated with medical device remedial actions, if all of the following conditions apply:

(1) You submit an RAE notification to us. Your RAE notification must be filed with or after submission of one or more 5-day or 30-day initial reports on events that are subject to a remedial action to be covered under this exemption. Your MDR report(s) must be filed within the required timeframe and cannot be delayed in order to be included in an RAE notification. You cannot utilize this exemption until at least one applicable MDR report is sent to us. All required baseline reports must also be filed with the 5-day or 30-day report.

(2) You notify the appropriate FDA District Office of the remedial action prior to or at the time of submission of the RAE notification.

(3) You conduct a complete complaint investigation as required by the Quality System Regulation (21 CFR 820).

(4) Your RAE notification references this exemption and states that future incidents meeting all of the conditions will not be reported to us. Your notification should include all of the following information:

(a) the identity of the FDA District Office that you informed (including the name and address of the person contacted ) about the remedial action,

(b) the date and method used to inform the District Office,

(c) a description of the nature of the notification to customer, such as a letter,

(d) the range of device model numbers, catalog numbers, serial numbers, or lot numbers covered by the remedial action,

(e) a complete description of the reported problem, including specific components as appropriate, that adequately explains why the product is undergoing a remedial action, and

(f) the manufacturer MDR report number(s) for the initial 5-day or 30-day MDR report filed for the remedial action, or a statement that the MDR that triggered the 5-day or 30-day report is attached to the RAE.

FDA Warns of Risks Associated with Eye-Catching Contact Lenses

2006-10-31T07:17:00.000-08:00

The FDA issued a notice to remind consumers about the risks of using decorative contact lenses.

The agency pointed to a need for heightened public awareness about the lenses during the Halloween season, when they are popular among celebrators and are marketed aggressively.

In 2005, decorative contact lenses were classified under the Federal Food, Drug and Cosmetic Act as devices, meaning that lenses distributed without 'appropriate involvement' by an eyecare professional are 'considered misbranded devices under the law,' the FDA said.

Public Citizen Calls for Criminal Investigation of Breast Implant Manufacturer for Withholding Safety Data from FDA

2006-10-28T16:41:00.000-07:00

Company Studies Showed Dangers Associated With Silicone Gel Implants.

Public Citizen today called for a criminal investigation into Mentor Corporation’s apparent failure to send the Food and Drug Administration (FDA) data showing safety problems with their silicone gel implants.

The consumer advocacy organization also called on the FDA to wait until it has reviewed all available safety data before deciding whether to approve the implants.

healthy news

Merck with Another Painkiller

2006-10-28T16:37:00.000-07:00

Merck is currently fighting the world’s largest civil action suit over its COX-2 painkiller Vioxx, which is being blamed for causing heart failure, sometimes fatal. So far, the courts seem to agree with the patients and their families.

However, Merck is asking for approval of another COX-2 painkiller, Arcoxia (etoricoxib). It points to the results of several trials, known as the Multinational Etoricoxib and Diclofenac Arthritis Long-Term program (MEDAL), that suggest the drug is as safe as diclofenac, another painkiller, and didn’t increase the risk of heart failure.

Journal of the American Medical Association

Approval for Bipolar Pill

2006-10-28T16:33:00.000-07:00

A new formulation of the schizophrenia drug Seroquel has been approved in the United States for the treatment of both manic and depressive episodes of bipolar disorders, making it the first drug of its kind, the Associated Press reported.

Serouquel was previously approved in the United States to treat acute manic episodes associated with schizophrenia and bipolar disorder. The new FDA approval, announced Monday, allows the drug to also be used to treat depressive episodes.

Drug maker AstraZeneca PLC has applied for similar approvals in Canada and the European Union, the AP reported.

Altana Gets US Approval for New Nasal Spray

2006-10-23T07:11:00.000-07:00

German drug maker Altana AG said on Monday it received approval to market its new nasal spray Omnaris in the lucrative United States market.

Drug-Coated Stents May be Losing Favor

2006-10-20T14:02:00.000-07:00

After a three-year run in which drug-coated stents grew into one of the most profitable, fastest-selling medical devices in history, doctors now appear to be using fewer of them -- a change that could hurt local life-science giant Boston Scientific Corp.

As more evidence emerges that suggests drug-coated stents have caused higher rates of blood clots than the older generation of bare-metal stents, doctors at many hospitals have recently begun shifting toward the older, bare-metal stents they replaced, according to figures provided yesterday to the Globe by Goodroe Healthcare Solutions LLC.

FDA Announces Guidance on Out-of-Specification Test Results

2006-10-20T13:54:00.000-07:00

In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.The designation also covers in-process laboratory tests.

The document, 'Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production,' is being published in the Oct. 12 Federal Register."

Former FDA Commisioner Crawford Pleads Guilty to Fraud

2006-10-20T13:49:00.000-07:00

Lester Crawford, the former FDA commissioner who abruptly left the agency two months after being confirmed, pleaded guilty to failing to disclose financial conflicts and making false statements, but is unlikely to spend more than a few months in prison, his attorney says.

The sentencing is scheduled for Jan. 22, Crawford's attorney, Barbara Van Gelder of Wiley Rein & Fielding, said. While the judge will determine the sentence, the Department of Justice (DOJ) has agreed to no more than six months in prison and will not object to the lower end of the range, she added.

Boston Scientific WinsEuropean Approval for Promus Stent

2006-10-18T00:20:00.000-07:00

European regulators have granted approval to a second stent system from Boston Scientific Corp.

The Natick, Mass. company announced on Monday that regulators approved its Promus coronary stent system, allowing the product to be marketed in the 25 European Union Countries.

Merck Diabetes Drug Wins FDA OK

2006-10-18T00:11:00.000-07:00

Diabetics gained a new way of controlling their blood sugar levels Tuesday, with FDA approval of a novel pill that enhances the body's own ability to lower blood sugar levels.

The FDA said it approved Januvia to treat Type 2 diabetes, a disease that affects about 20 million Americans.

Clinical trials showed the new pill works just as well as older diabetes drugs, but with fewer side effects like weight gain. The drug is made by Merck and Co. Inc.

FDA Approves New Combination Therapy for Lung Cancer

2006-10-14T11:14:00.000-07:00

The U.S. Food and Drug Administration (FDA) approved the use of Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer.

This approval was based on an improvement in survival time when Avastin was added to a standard chemotherapy regimen."

Guidant Wins Again in Medtronic Patent Lawsuit

2006-10-14T11:10:00.000-07:00

Boston Scientific announced Oct. 12 that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against Medtronic.

The court affirmed the validity of a cardiac resynchronization patent; Medtronic had filed a declaratory judgment action against Guidant alleging that certain claims in the patent were invalid.

The patent in question was U.S. Patent RE38,119 ('119 patent), which Guidant said it has exclusively licensed from Mirowski Family Ventures, the entity that holds the patent rights of Michel Mirowski, inventor of the implantable defibrillator

FDA Issues Detailed Requiements for Device Reprocessors

2006-10-14T11:07:00.000-07:00

Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent guidelines.

The FDA Sept. 25 issued a rule and guidance on reprocessed single-use devices (SUDs).
The rule, published as both a proposed and a direct final rule, updates information on reused devices that require premarket submissions, or 510(k)s.

The guidance details validation data requirements for reprocessed SUDs, which include cleaning, sterilization and functional performance data showing a reprocessed device is 'substantially equivalent' to the original device 'after the maximum number of times [it] is reprocessed as intended.'

Two Firms Should Recall Unapproved Drugs, FDA Says

2006-10-14T11:02:00.000-07:00

The FDA announced a crackdown on two companies' marketing of unapproved drugs, including a consent decree prohibiting them from continuing the practice and a request by the agency to recall all they have already sold.

In addition to the action against Syntho Pharmaceuticals and Intermax Pharmaceuticals, the agency said Oct. 5 it sent warning letters to four other firms as part of its ongoing effort against marketed unapproved drugs.

Syntho and Intermax manufactured and distributed drugs without the required FDA approval, the agency said, adding that the products also did not meet current good manufacturing practices (cGMP).

Cook's Zenith Branch Endovascular Graft Receives CE Mark Approval

2006-10-11T21:25:00.000-07:00

William Cook Australia, a global leader in endovascular therapy products, has taken another major step forward in the treatment of complex aortic aneurysms. The Zenith Branch Endovascular Graft, a new product using Cook's groundbreaking Zenith anchored endograft technology, has received CE Marking approval in Europe, allowing its distribution in the European Union and other countries that recognize the CE Mark.

Supreme Court Denies Zoloft Patent Case

2006-10-11T21:22:00.000-07:00

The Supreme Court said Tuesday that it will not hear a case brought by a generic pharmaceutical company that sought to invalidate a patent held by Pfizer Inc. for its blockbuster anti-depression drug Zoloft.

The case, brought by Winnipeg, Canada-based Apotex Inc., involved a controversial issue in the pharmaceutical industry: whether generic drug makers are sometimes blocked from issuing new products by brand-name companies that refuse to sue them for patent infringement during the FDA approval process.

FDA Notes Possible Risk for Pregnant Women Taking Lamictal

2006-10-11T21:17:00.000-07:00

The FDA said Sept. 29 that babies exposed during the first three months of pregnancy to the drug Lamictal, which is used to treat epileptic seizures and bipolar disorder, may have a higher chance of being born with a cleft lip or cleft palate.

The agency issued separate advisories to healthcare professionals and patients, suggesting that, although more research is needed, women who are pregnant and taking or thinking about taking Lamictal (lamotrigine) should not start or stop without first talking to their physicians. The 'new preliminary information' comes from the North American Antiepileptic Drug Pregnancy Registry.

FDA Recommends Schedule II Classification for New ADHD Drug

2006-10-11T21:15:00.000-07:00

The FDA issued an approvable letter for New River Pharmaceuticals’ and Shire Pharmaceuticals’ attention-deficit/hyperactivity disorder (ADHD) drug NRP104, but without the initial classification some analysts believed would give it a significant edge over competitors.

The FDA did not request any additional studies for the drug, but it is withholding final approval pending a scheduling decision by the Drug Enforcement Administration (DEA), which regulates controlled substances based on their potential level for abuse.

The FDA recommended that NRP104 receive a Schedule II classification, which is used for drugs, like amphetamines, that are approved for medical use but have the highest potential for abuse.

FDA Recommends Schedule II Classification for New ADHD Drug

2006-10-11T21:14:00.000-07:00

ComCom to Assess Johnson's Pfizer Deal

2006-10-08T21:06:00.001-07:00

Johnson & Johnson has filed an application with the Commerce Commission regarding its global acquisition of the consumer healthcare division of Pfizer Inc.

Johnson & Johnson is listed on the New York Stock Exchange and runs three business segments: consumer; pharmaceutical; and medical devices and diagnostics. "

ComCom to Assess Johnson's Pfizer Deal

2006-10-08T21:06:00.000-07:00

Company Issues Pasta Recall

2006-10-04T20:58:00.000-07:00

Unilever, in cooperation with the Food and Drug Administration, is voluntarily recalling batches of its 'Knorr-Lipton Pasta Sides Chicken … Fettucini in a Savory Chicken Flavored Sauce' product because it may contain undeclared milk.

People with an allergy or severe sensitivity to milk run the risk of a serious or
life-threatening allergic reaction if they consume the product, the company said. It
said one adverse reaction has been reported to date.

The recall was initiated after the company received a consumer complaint and it was discovered the packaging did not reveal the presence of milk in the ingredient list on the label.

The product was distributed nationwide in 4.3-ounce packages, the company said. The packages are marked with UPC No. 4100002246 on the back of the pouch and Best If Used By dates of SEP11 2007, SEP12 2007, SEP13 2007, SEP 14 2007 or SEP20 2007.Company issues pasta recall.

Cases of Botulism Linked to Juice

2006-10-04T20:54:00.000-07:00

The Winnebago County Health Department advises area residents to not drink and to throw away Bolthouse Farms 100 percent Carrot Juice in either 450 ml and 1 liter plastic bottles with “Best Used By” dates of Nov. 11.

The health department has also notified all local retail food stores to pull the product from its shelves.

The U.S. Food and Drug Administration issued a recall on Sept. 30 in response to a fourth case of botulism linked to Bolthouse Farms, Bakersfield, CA, brand carrot juice.Cases of botulism linked to juice.

New Products Making Spine Market Shine

2006-10-04T20:48:00.000-07:00

It looks like Kyphon's six-year run of virtual freedom from competition in the spine bone fracture treatment market is coming to an end, Lazard Capital Markets analyst Alexander Arrow said Oct. 2.

In a report following the North American Spine Society (NASS) trade show, Arrow pointed to a series of promising new products that should interest investors.

'Disc-OTech's newly-launched Confidence product has significant appeal … and may become the dominant product in the vertebroplasty category,' which would take more shares from ArthroCare and Stryker than from Kyphon, Arrow said. Vertebroplasty is a relatively new technique in which medical-grade cement is injected though a needle into a bone fracture to stabilize it.

Hearing Device OK'd

2006-09-30T20:02:00.000-07:00

Federal regulators yesterday approved Boston Scientific Corp.'s second generation device for helping the severe-to-profoundly deaf, hear.

Boston Scientific said its Harmony HiResolution Bionic Ear System received Food and Drug Administration clearance, following similar approval from the respective European and Canadian agencies, and will be available for adults in the United States in early 2007.

J&J to Add New Study results to Ortho Evra Label

2006-09-30T20:00:00.000-07:00

The FDA announced that the results of two epidemiology studies sponsored by Johnson & Johnson (J&J) will be added to the warning portion of the label for the birth control patch Ortho Evra.

FDA Cites Reliant for Heart Drug Promotion

2006-09-28T22:44:00.000-07:00

Reliant Pharmaceuticals failed to disclose any risk information in two promotional pieces for its Rythmol SR extended-release capsules and suggested that the product is effective for more indications than those approved by the FDA, the agency said in a warning letter to the company.

Thus, the pieces are 'false or misleading' and amount to 'misbranding' the drug, the warning letter said.

The warning letter, issued Sept. 14 and posted to the FDA website Sept. 15, said that the promotional pieces are misleading because they make numerous claims about the use of Rythmol SR in treating atrial fibrillation, but do not include information on risks associated with the drug. 'By omitting the most serious and frequently occurring risks associated with the drug, these pieces misleadingly suggest that Rythmol SR is safer than has been demonstrated by substantial evidence or substantial clinical experience.'

HRS Issues Final Recommendation on Heart Device Oversight

2006-09-28T22:26:00.000-07:00

The Heart Rhythm Society (HRS) Sept. 28 issued its final recommendations on the device recall process and the performance of pacemakers and implantable cardioverter defibrillators.

The report addresses the group's 'overriding objectives,' which include:

Establishing greater transparency in the postmarket surveillance, analysis and reporting of device information

Establishing new systems to identify malfunctioning devices more quickly

Implementing standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified

Examining the global scope of device performance issues

Merck to $95 million Stake in Foxhollow

2006-09-28T22:08:00.000-07:00

Merck & Co. will buy a $95 million stake — about 11 percent — in FoxHollow Technologies Inc. as the two companies expand a research collaboration.

Whitehouse Station, N.J.-based Merck and Redwood City-based FoxHollow started working together a year ago, seeking cardiovascular biomarkers to use in medical tests and drug research. They've since expanded their work together on studies of plaque removed from arteries by a FoxHollow device.

Court Rules Aganst Imclonein Patent Lawsuit

2006-09-27T21:23:00.000-07:00

ImClone Systems suffered a major legal defeat Sept. 18 when U.S. District Judge Naomi Reice Buchwald ruled that three Israeli scientists actually invented the cancer treatment the company sells under the trade name Erbitux.

The judge ordered the U.S. Patent and Trademark Office to transfer the relevant patent (No. 6,217,866) into the names of the three Israeli scientists, Michael Sela, Esther Aboud-Pirak and Esther Hurwitz. The patent is currently registered to seven other scientists who have transferred their legal rights to ImClone and Aventis Pharmaceuticals, a co-defendant in the lawsuit.

Merck Wins Latest Federal Vioxx Case

2006-09-27T21:18:00.000-07:00

A federal jury on Tuesday cleared Merck & Co. of being liable for the heart attack of a Kentucky man who took the company's Vioxx painkiller for less than five months.

Robert Garry Smith, 56, a manager at a chemical plant, began taking Vioxx in 2002, after the medication's label was changed to reflect a study's results that use of the drug caused increased risks of cardiovascular problems. Smith had a heart attack in February 2003.

It was Merck's second victory out of three federal trials resulting in verdicts in U.S. District Court in New Orleans.

Johnson andJohnson Sues Boston Scientific, Abbtt, Guidant for $5.5 Billion

2006-09-27T21:15:00.000-07:00

Johnson & Johnson (J&J) has filed a suit seeking "no less than" $5.5 billion in damages from Boston Scientific, Abbott Laboratories and Guidant, alleging leaked confidential information led to Boston Scientific winning a bidding war to acquire Guidant.

"While Boston Scientific ultimately succeeded in its takeover bid for Guidant, it did so only because Guidant leaked confidential information to a third party — Abbott," states the suit, filed Sept. 25 in the U.S. District Court for the Southern District of New York.

Abbott had agreed to license certain patents from J&J to resolve antitrust concerns related to the fact that if J&J and Guidant merged, they would own too large a share of the market for drug-eluting stents.

J&J was forced to abandon its bid to acquire Guidant after the heart devicemaker agreed to allow Boston Scientific to buy it for roughly $27 billion.

Actavis Drops Pliva Takeover Bid

2006-09-26T22:15:00.000-07:00

The long-running game of escalating bids for control of Croatian generic drugmaker Pliva appears to be over as Actavis has folded its hand and left Barr Pharmaceuticals as the only player at the table.

Actavis announced Sept. 18 that it would not counter an offer Barr made for $141 per share, saying it considered its previous bid of $137 per share to be a 'full and fair price.' While the company said it reserves the right to re-enter the process, it is asking the Croatian Financial Services Supervisory Agency to release the guarantee it provided. The tender offer period is expected to expire on Oct. 11, according to Barr.

The bidding war increased Pliva's estimated value from the $1.6 billion initial offer from Actavis to the $2.5 billion Barr is currently promising. Both firms claim the acquisition would make them the third-largest generics manufacturer in the world.

FDA Approves Schering's Noxafil

2006-09-26T22:07:00.000-07:00

The FDA announced Sept. 18 it has approved Schering-Plough's drug Noxafil, which prevents invasive fungal infections in people with weakened immune systems.

The drug is designed to prevent infection caused by aspergillus and candida in patients with weakened immune systems following bone marrow transplants, as well as in patients in which cancer or chemotherapy have decreased their white-blood-cell count, making it difficult for their bodies to fight infections.

'Most healthy individuals are unaffected by these common fungi. However, individuals with severely weakened or abnormal immune systems may become seriously ill when exposed. These infections are often fatal for this population,' CDER Director Steven Galson said in a statement.

Edwards Lifesciences (EW) to Launch its LifeStent FlexStar and FlexStar XL Stent Delivery Systems

2006-09-26T21:57:00.000-07:00

Edwards Lifesciences Corporation (NYSE: EW) announced the U.S. launch of its LifeStent FlexStar and FlexStar XL stent delivery systems. FlexStar systems are designed to optimize the delivery of Edwards' LifeStent nitinol self-expanding stents, which feature a triple-helix design and are currently approved for biliary indication in the United States.

Edwards currently holds FDA 510(k) clearance for FlexStar systems to treat biliary obstructions, and an expanded European CE Mark including the treatment of peripheral vascular disease with stents up to 170 millimeters long.

Cephalon, Inc. (CEPH) Receives FDA Approval to Market FENTORA for Management of Pain with Cancer

2006-09-26T21:50:00.000-07:00

Cephalon, Inc. has received approval from the FDA to market FENTORA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

FENTORA is the first and only buccal tablet approved for this indication and is the second new product to be marketed by Cephalon this year. Cephalon expects FENTORA to be available in the United States during the first week of October 2006.

Nor-Sea Foods Recalls Hot Smoked Salmon

2006-09-25T20:23:00.000-07:00

The Agency is advising people not to eat certain batches of Morrisons Scottish Hot Smoked Salmon that have been recalled by its suppliers. A Food Alert for Information has been issued.

Nor-Sea Foods Limited has recalled a batch of Morrisons Scottish Hot Smoked Salmon (100g) with a use-by date of 27 September 2006, due to possible contamination with Listeria monocytogenes bacteria.

Certain people, such as pregnant women, babies, the elderly and people with reduced immunity, are particularly vulnerable to infection by Listeria monocytogenes."

All Intravascular Devices Can Cause Bloodstream Infections

2006-09-25T20:15:00.000-07:00

All types of intravascular devices (IVDs) pose a risk of bloodstream infection to patients, according to a study published in the September issue of Mayo Clinic Proceedings, the Mayo Clinic said Sept. 22.

An IVD is any device that allows access to the bloodstream, typically a catheter. Up to 500,000 IVD-related bloodstream infections occur annually in the U.S., costing $4,000 to $56,000 per episode, the Mayo Clinic said. These are also considered to be the most preventable class of hospital-acquired infections, the clinic added.

IOM Report Blasts FDA, Calls for More Postmarket Enforcement

2006-09-25T20:12:00.000-07:00

The FDA should be given the authority to impose severe punishments on drug manufacturers who don't live up to their postmarketing commitments, according to an Institute of Medicine (IOM) report that offered a harsh assessment of the agency's current drug safety efforts.

The FDA is underfunded, disorganized and lacking in sufficient authority to enforce the laws on the books, according to the Sept. 22 report, 'The Future of Drug Safety: Promoting and Protecting the Health of the Public.' The FDA and HHS requested the study, which began 18 months ago.

IOM recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products.

'These conditions may be imposed both before and after approval of a new molecular entity, new indication or new dosage, as well as after identification of new contraindications or patterns of adverse events,' the report states. 'The limitations imposed should match the specific safety concerns and benefits presented by the drug product.'

FDA Publishes Rule on Reprocessed SUDs

2006-09-23T09:34:00.000-07:00

The FDA published Sept. 25 a rule on submitting validation data for reprocessed single-use devices (SUDs).

The rule amends certain classification regulations for:
Reprocessed SUDs whose exemption from premarket notification (510(k)) requirements have been terminated; and

Other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act, are necessary in a 510(k).

The rule was published as both a direct final rule and a proposed rule. The proposed rule provides 'a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule,' the agency said.

Recent FDA Decisions Drive Latest Reform Bill

2006-09-23T09:29:00.000-07:00

Legislation is necessary to force the FDA to more carefully assess the impact on women of its drug and device approvals, a House Democrat says.

Rep. Rosa DeLauro (D-Conn.) will introduce her bill, 'The FDA Scientific Fairness for Women Act,' next week to address what she sees as an erosion of protections for women regarding drugs and devices. DeLauro is concerned with the agency's recent decision against approving Barr's contraceptive Plan B for OTC sale to minors and its tentative approval of silicone breast implants.

These decisions are a sign of an agency that has been corrupted by political and industry influence, she added. The FDA's image as the 'gold standard' for protection of human health 'has been tarnished in recent years,' she said during a Sept. 21 conference call announcing the bill.

2 More Deaths May Be Linked to E.coli Spinach

2006-09-23T09:24:00.000-07:00

A 2-year-old boy from Idaho and an 86-year-old woman from Maryland may have died from the tainted bagged spinach.

U.S. officials searching for the source of an E. coli outbreak that may have killed three people said on Friday they had found 'situations of concern' at farms and food processing plants in California but cleared spinach grown elsewhere in the country.

The Food and Drug Administration said 166 people in 25 states had been sickened in the outbreak, with one death. State health officials reported on Friday a 2-year-old boy from Idaho and an 86-year-old woman from Maryland had died and said they suspected E. coli from spinach was to blame. FDA officials said they could not confirm that link.

Federal and state officials were inspecting nine farms in California's Salinas Valley, where the outbreak of E. coli 0157:H7 is suspected to have originated.

Fresh Spinach May Be Back in Stores Soon

2006-09-23T09:21:00.000-07:00

It's safe to eat spinach grown outside California's Salinas Valley, federal health officials say, and the leafy greens could return to produce shelves in a few days.

An ongoing outbreak of E. coli linked to fresh spinach had sickened 166 people in 25 states through Friday. That's up from 157 victims in 23 states a day earlier, according to the Centers for Disease Control and Prevention.

For more than a week, the Food and Drug Administration has recommend people not eat fresh, raw spinach. State and federal investigators since have traced the contaminated spinach back to three California counties, and already farm inspections there are turning up possible problems.

Medtronic Micro-Driver Coronary Stent Approved in Japan

2006-09-20T20:49:00.000-07:00

Japanese regulators have approved Medtronic's Micro-Driver coronary stent, the firm said Sept. 19.

The Micro-Driver is made of cobalt-chromium allow and designed for small blood vessels requiring stents smaller than 3 millimeters in diameter, Medtronic said. The device is an extension of the Medtronic Driver, an implanted bare metal stent for patients with larger blood vessels.

Cobalt-chromium stents are stronger and denser than stainless steel stents, but provide excellent flexibility, deliverability and vessel support following angioplasty procedures, the firm said.

MDS Misrepresented Study Status, FDA Says

2006-09-20T20:47:00.000-07:00

The FDA has accused life sciences company MDS of misrepresenting the status of studies it was conducting and said it found problems with the analytical methods the company used in more than 30 studies of six different drugs, according to an agency warning letter issued Aug. 31.

The letter, which was posted to the FDA's website Sept. 11, followed inspections conducted at company facilities in Saint Laurent, Montreal, and Blainville, Quebec, during which the agency said it found 'widespread problems' at both locations.

The inspection was part of the Bioresearch Monitoring Program, a standard-setting initiative for clinical trials. "

Birth-Control Patch Label Warns of Possible Increased Blood Clot Risk

2006-09-20T20:43:00.000-07:00

The risk of blood clots in the legs and lungs may be higher for women using the birth-control patch instead of the pill, according to a warning on the product's label disclosed Wednesday.

The Food and Drug Administration said it updated the label on the Ortho Evra birth-control patch to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. However, a second study found no difference in risk between the two forms of birth control.

'Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women,' the FDA said in a notice published on its Web site.

Inhaled Insulin Under Study In Greenville

2006-09-20T20:39:00.000-07:00

For many diabetics, daily insulin injections are the norm. However, a new drug treatment for Type 1 and 2 Diabetes, which is being tested right here in Eastern Carolina, may make needle injections obsolete one day.

A clinical trial of inhaled insulin is underway in Greenville.

Dr. Mark Warren, an Endocrinologist, is involved in the study and says inhaled insulin is cutting edge technology.

Doctors Advise Care in Outbreak

2006-09-20T20:36:00.000-07:00

With one of the healthiest of all fresh vegetables, spinach, making people ill and killing at least one person, we asked experts yesterday for advice on how to deal with the threat of E. coli contamination.

Basically, avoid all fresh spinach and salad blends containing spinach until the FDA determines the origin of this E. coli outbreak. You can eat other fresh fruits and vegetables, as long as you wash them and your hands well.

'The best thing right now is not to panic,' said Dr. Keith Schneider, associate professor of Food Science and Human Nutrition at the University of Florida. 'Avoid spinach, but I wouldn't reach for the Twinkies and Pop Tarts right now.'

Ibuprofen May Hinder Asprin's Protection Against Heart Attacks

2006-09-19T20:18:00.000-07:00

Patients who take low-dose aspirin to help prevent heart attacks may interfere with that protection if they also take the painkiller ibuprofen, according to an FDA announcement.

In a background paper released Sept. 8, CDER said that healthcare professionals should advise consumers and patients on the appropriate use of aspirin and ibuprofen in combination. Aspirin is used 'for secondary prevention of myocardial infarction,' the paper noted.

Cases Hit 131 in 21 States

2006-09-19T20:15:00.000-07:00

As U.S. and California health officials scoured Salina Valley spinach fields for the source of a massive outbreak of E. coli contamination, the number of victims rose to 131 in 21 states on Tuesday.

FDA Advisers Endorse Steel Spinal Disks

2006-09-19T20:13:00.000-07:00

A stainless steel device meant to replace natural but diseased shock-absorbing disks in the neck should receive government approval, government health advisers said Tuesday.

The two-part device is meant as an alternative to spinal fusion surgery in patients suffering from degenerative disc disease. The manufacturer of the Prestige Cervical Disc System, Medtronic Inc., said its device can help maintain motion and flexibility in patients, while relieving pain.

The Food and Drug Administration's Orthopaedic and Rehabilitation Devices panel unanimously recommended the agency approve the device with conditions. The conditions include a requirement that Medtronic continue to study the device once it's on the market.

More Potent Strain of E. coli Feared

2006-09-19T20:11:00.000-07:00

Federal health officials are investigating whether a more potent strain of E. coli is behind an outbreak linked to fresh spinach that has sickened at least 131 people, half of whom have been hospitalized.

The Centers for Disease Control and Prevention said Tuesday that fully 50 percent of those reported sick in the outbreak were hospitalized. That's more than the 25 percent to 30 percent seen in other E. coli outbreaks, said Dr. David Acheson of the Food and Drug Administration's Center for Food Safety and Applied Nutrition.

'We're running higher than that,' Acheson told reporters in a conference call. 'One possibility is this is a virulent strain.'

Also unexpected was the 15 percent of food poisoning victims who developed a type of kidney failure called hemolytic-uremic syndrome. Five percent is more typical, Acheson said.

He cautioned that the numbers could be skewed by underreporting of less severe cases of illness: 'It's too early to say at this point,' he added.

Schering-Plough Eyeing Bristol- Myers

2006-09-15T22:36:00.000-07:00

Schering-Plough Corp. is seriously considering approaching Bristol-Myers Squibb Co. about a possible merger, according to a report in The Star-Ledger newspaper on Friday.

FDA Nomination Faces Obsticles

2006-09-15T22:33:00.000-07:00

Two Capitol Hill Republicans are threatening to block U.S. President George W. Bush's nominee to head the Food and Drug Administration.

Sen. David Vitter, R-La., told The New York Times he would block the nomination of Dr. Andrew C. von Eschenbach to become FDA commissioner unless the administration legalizes imports of some prescription drugs.

FDA Sends Warning Letter for Astellas for Misleading AD

2006-09-15T22:31:00.000-07:00

Astellas Pharma US made 'unsubstantiated' claims about its anti-rejection drug Prograf and minimized its risks when it placed an ad in a professional journal, the FDA said in a warning letter to the company.

The warning letter, which was dated Aug. 31 and posted to the FDA website Sept. 5, said the company had claimed in the ad that Prograf (tacrolimus capsules and injection), is superior to cyclosporine in that it promotes 'stable renal function' and a 'favorable cardiovascular profile.' These claims, however, are not backed up with substantial evidence or clinical experience, the letter said.

The claim about the favorable cardiovascular profile 'misleadingly minimizes the cardiovascular risks associated with Prograf therapy,' and the one about stable renal function 'misleadingly minimizes the nephrotoxicity associated with Prograf therapy,' the warning letter added.

Tainted Spinach Traced to California Company

2006-09-15T22:26:00.000-07:00

If you've got a bag of fresh spinach in your refrigerator, don't eat it. It could make you very sick or even kill you.

Federal health officials say they have tracked down at least one source of a nationwide E. coli outbreak.
The Food and Drug Administration says bagged spinach products distributed by Natural Selection Foods, based in San Juan Bautista, California, appear to be a source of the problem.

Natural Selection Foods has recalled all packages of its fresh spinach and any salad with spinach in a blend. The affected packages have 'Best if Used by Dates' of Aug. 17 through Oct. 1. Consumers with questions can contact the company at 800-690-3200.

Spinach Scare Hits Locally

2006-09-15T22:23:00.000-07:00

An E. coli outbreak in eight states means area grocery stores have stopped carrying the vegetable.
After the Food & Drug Administration issued a warning Thursday about E. coli outbreaks possibly from bagged spinach, area supermarkets took the vegetable off the shelf.

The FDA blamed one death and multiple hospitalizations across eight states on the bacterium. There have been no reported cases in Florida.

Despite no cases thus far, the Charlotte County Health Department is advising residents to throw away any bagged spinach they may have, said Garry Allshouse, epidemiology supervisor.

Ex-Abtox CEO Gets 10 Years, $17.2 Million Fine for Selling Products that Caused Blindness

2006-09-14T21:08:00.000-07:00

A former CEO whose firm sold faulty devices was sentenced Sept. 13 by a federal judge to 10 years in prison and ordered to pay $17.2 million in restitution, according to reports.

Former AbTox chief Ross Caputo and fellow executive Robert Riley knowingly sold sterilization equipment that caused blindness in 18 people undergoing eye surgery, according to the U.S. attorneys on the case.

The devices were sold to hospitals for about $100,00 each, they noted.

The two executives were convicted April 20 of wire and mail fraud, selling an adulterated or misbranded device and conspiracy to defraud the FDA.

Actavis Announces FDA Warning Letter Following FDA Inspection

2006-09-14T21:04:00.000-07:00

Actavis Group, the international generic pharmaceuticals company, announced that it has received a warning letter from the U.S. Food and Drug Administration (FDA), related to its inspection of the Group's solid oral dose manufacturing facility in Little Falls, New Jersey.

Feds Warn Against Bagged Spinach After E. coli Outbreak

2006-09-14T21:01:00.000-07:00

Federal health officials are warning consumers not to eat bagged fresh spinach after an E. coli outbreak in eight states.

They said at least one person has died and 50 others have gotten sick.

The death occurred in Wisconsin, where 19 others were also sickened, according to the Food and Drug Administration. The outbreak has sickened others -- eight of them seriously -- in Connecticut, Idaho, Indiana, Michigan, New Mexico, Oregon and Utah.

FDA officials said they don't know the source of the outbreak, but it appears to be linked to bagged spinach.

E. coli causes diarrhea, often with bloody stools. Most healthy adults can recover completely within a week, although some people -- including the very young and old -- can develop a form of kidney failure that often leads to death.

FDA Wants Further Stent-Safety Study

2006-09-14T20:59:00.000-07:00

An outside panel of health experts will examine whether drug-coated stents that are used to prop open coronary arteries can produce sometimes-fatal blood clots, the Food and Drug Administration (FDA) said Thursday.

The announcement comes after two recent studies suggested a small but significant increase in the rate of heart attacks and deaths caused by blood clots in patients outfitted with the metal-mesh tubes. The stents slowly release drugs that help keep arteries unclogged.

The FDA said it continues to believe that the stents are safe and effective.

However, the agency wants one of its outside committees to examine whether further studies or changes to the labeling of the devices are needed.

ENDOCARE RECEIVES FDA 510K CLEARANCE TO MARKET NEW NITROGEN-BASED CRYOABLATION SYSTEM FOR DESTROYING TISSUE AND CANCEROUS TUMORS

2006-09-13T21:38:00.000-07:00

Endocare, Inc., an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation, announced that it has received 510K clearance from the U.S. Food and Drug Administration to market its new Cryocare CN2 System, a potentially much faster and easier-to-operate cryoablation system for freezing cancerous tumors and tissue.

This new system uses nitrogen as the freezing and tumor-destroying element. The nitrogen, called 'critical nitrogen' because it works in a unique form at the critical point where gas nearly becomes liquid, is also more powerful and more readily available in surgical suites than argon, the freezing element in Endocare's current market-leading cryoablation systems.

MEDTRONIC SAYS IT WILL FIX DRUG-PUMP CATHETER FLAWS

2006-09-13T21:35:00.000-07:00

Medtronic Inc. said Tuesday it will have a plan to correct problems with two of its drug-pump catheters this week after the U.S. Food and Drug Administration slapped its most serious recall designation on the devices.

FDA APPROVES 'TOTALLY IMPLANTED' PERMANENT ARTIFICIAL HEART

2006-09-13T21:34:00.000-07:00

The FDA approved the first 'totally implanted artificial heart' for patients with advanced heart failure, the agency announced Sept. 5.

The AbioCor Implantable Replacement Heart is made by Abiomed.

It is intended for patients with advanced heart failure in both pumping chambers of the heart who are ineligible for heart transplants due to advanced age or medical conditions. These conditions include very elevated pressure in the lungs, severe diabetes or kidney failure.

The artificial heart is intended for patients who are unlikely to live more than a month without intervention.

The FDA approved it under the humanitarian use device provisions of the Food, Drug and Cosmetic Act, as the number of patients affected is fewer than 4,000 a year.

Bill Would Require Girls to be Vaccinated Against Cancer

2006-09-13T21:31:00.000-07:00

FDA calls vaccine a breakthrough in prevention.

Michigan girls entering the sixth grade next year would have to be vaccinated against cervical cancer under bills backed Tuesday by a bipartisan group of female lawmakers.

The legislation is the first of its kind in the United States, said state Sen. Beverly Hammerstrom, the lead sponsor.

The vaccine was approved by the Food and Drug Administration in June for use in girls as young as 9, up to age 26, and has been hailed as a breakthrough in cancer prevention. It prevents infections from some strains of the sexually transmitted human papilloma virus, which can cause cervical cancer and genital warts.

A government advisory panel recommended that 11- and 12-year-old girls be routinely vaccinated against the virus but stopped short of recommending the vaccine be required by schools.

Study: Naproxen Best Painkiller for Most People

2006-09-13T21:06:00.000-07:00

Worried that your painkiller could trigger a heart attack or dangerous stomach bleeding?

New reports on painkiller risks, based on reviews of dozens of studies including hundreds of thousands of patients, indicate most patients should try naproxen, an older anti-inflammatory drug.

Experts say it doesn't raise heart attack or stroke risk — a major worry for older people — and naproxen is inexpensive because generic versions have been around for years. Available over the counter, it's taken by millions of Americans.

FDA POSTS INFORMATION ON RECENTLY APPROVED NAVISTAR CATHETER

2006-09-12T23:51:00.000-07:00

The FDA Sept. 12 posted information on the Navistar ThermoCool deflectable diagnostic/ablation catheter, which the agency approved Aug. 11.

The device is manufactured by Biosense Webster. It is used with related accessories and the Stockert 70 radio-frequency generator to treat recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (heart attack) in adults, the agency said.
VT is a fast heart rhythm that occurs within the lower chambers of the heart (the ventricles). Symptoms of VT include palpitations, shortness of breath or lightheadedness.

The FDA approval letter for the Navistar can be viewed at www.fda.gov/cdrh/pdf4/P040036a.pdf

PFIZER'S NORVASC PATENT UPHELD IN FEDERAL COURT

2006-09-12T23:48:00.000-07:00

Generic drugmaker Synthon will have to wait until September 2007 to market a version of Pfizer's hypertension drug Norvasc unless it successfully appeals a recent ruling by North Carolina's Middle District court.

Pfizer announced Sept. 1 that the court ruled its patent on Norvasc (amlodipine besylate) is valid and infringed on by Synthon's generic product.

Norvasc generated $2.34 billion in sales during the first half of 2006 and is the most prescribed hypertension drug in the world, Pfizer said.

Drug May Cut Off Tumor's Blood Supply

2006-09-12T23:35:00.000-07:00

September 12, 2006

When breast cancer spreads to other parts of the body, it can be deadly. Now, a new drug stops advanced breast cancer from progressing - and even reduces the size of tumors.

About 10 years ago, Karen Pike got the news. The mother of two had breast cancer.

'I don't have any history in my family, so at 37, it was pretty scary. Our kids are 5 and 7, and I just went numb,' she said.

Karen's faith and family helped her stay strong. She needed the strength when the cancer came back three more times.

There are now a number of drugs that work by interfering with the process known as angiogenesis, which refers to new blood vessel formation. A new drug might stop it altogether.

Karen has also relied on a team of doctors -- and is now part of a clinical trial on a drug called SUTENT. In a study, the pill shrank tumors by a third or more in 15 percent of patients -- significant because they had very advanced diseases and didn't have any luck with other treatments.

New Painkiller Studies Show New Risks

2006-09-12T23:25:00.000-07:00

September 12, 2006

Worried that your painkiller could trigger a heart attack or dangerous stomach bleeding? New reports on painkiller risks, based on reviews of dozens of studies including hundreds of thousands of patients, indicate most patients should try naproxen, an older anti-inflammatory drug.

Experts say it doesn't raise heart attack or stroke risk - a major worry for older people - and naproxen is inexpensive because generic versions have been around for years. Available over the counter, it's taken by millions of Americans.

The drawback is that like most painkillers, it can irritate the stomach, so doctors say some people may also need to take one of the newer acid reflux drugs.
'I do think we should start with naproxen in the vast majority of cases,' said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic and president of the American College of Cardiology. 'It's about balancing the cardiovascular and gastrointestinal risk.

FDA Asks for More Data on Genentech's Avastin

2006-09-11T21:42:00.000-07:00

September 11, 2006

The Food and Drug Administration wants more information before it decides whether to approve the Genentech blockbuster drug Avastin as a treatment for advanced breast cancer.

South San Francisco-based Genentech originally hoped to begin marketing the drug as a treatment for advanced breast cancer by early next year.
Now, following an F-D-A request for additional safety and efficacy data, Genentech says it will likely take an extra six months to roll out the drug.

FDA has Concerns About Expanding Use of Antibiotic

2006-09-11T21:39:00.000-07:00

September 11, 2006

You don't want to cure one problem and create another. So federal health officials suggest doing more research into an antibiotic that's being proposed to treat acute sinus infections.
Factive has been used for pneumonia and acute bronchitis the last three years. Now, the manufacturer wants the O-K to use it on acute sinusitis.

But the Food and Drug Administration has concerns over serious skin reactions. According to the F-D-A, the risk of rashes from Factive is greater than what there is in other similar antibiotics.
The manufacturer, Oscient Pharmaceuticals, says Factive has a safety profile equivalent to other antibiotics.

At a meeting tomorrow, a group of outside experts will weigh-in on their thoughts about the drug."

BAXTER Recall

2006-09-08T21:13:00.000-07:00

BAXTER Recalls Vaporizer
September 08, 2006

Baxter is recalling its Sigma Delta Sevoflurane vaporizer, the company said recently. Interaction with the drug in the vaporizer led to degradation of materials in some units of the vaporizer, prompting the recall.

Degradation has occurred in the filling port shoe and the Sight glass, and can make it hard to establish the drug level in the device, Baxter said. However, the vaporizer continues to work effectively, according to the firm.

Mold Growth

2006-09-08T21:10:00.000-07:00

Inspection Uncovers Mold Growth, Leads to Warning Letter
September 08, 2006

An in vitro diagnostic manufacturer failed to investigate root causes of nonconformances, including fungus and mold growth, the FDA said in a recent warning letter.

The FDA cited Pointe Scientific for at least 10 nonconformances including stability failures, fungus and low recoveries. No investigations were conducted to determine root causes, the agency said

Sanofi-Aventis Drug Application Rejected

2006-09-08T21:07:00.000-07:00

FDA Rejects Sanofi-Aventis Drug Application
September 08, 2006

The FDA has issued a not approvable letter for sanofi-aventis' dronedarone, but the company vows to continue pursuing the product.

Sanofi-aventis also announced the U.S. District Court for the Central District of California has moved the patent trial date for its blood thinner Lovenox to Dec. 4.

Dronedarone is being developed by sanofi-aventis to treat atrial fibrillation and atrial flutter.

VIOXX

2006-09-08T21:04:00.000-07:00

VIOXX Report Clears Merck of Ignoring Risks, But Slams "Poor Judgement"September 08, 2006

Authors of a new report say it exonerates Merck from allegations that the company knowingly kept its painkiller Vioxx on the market despite underlying cardiovascular risks, but investigators also condemn Merck's "poor judgment and errors," including public statements that downplayed the health hazards.

Merck pulled the drug from the market roughly two years ago after preliminary clinical trial results found an increased risk of heart attack and stroke in patients taking the treatment.

2006-09-08T21:02:00.000-07:00

Feds Examine Safety of Mercury Fillings
September 08, 2006

Federal health officials are again examining what's known _ and what's still to be learned _ about the safety of a mercury mixture that's stirred controversy since dentists began using it to fill cavities in the 1800s.

A joint panel of outside experts voted Thursday to reject a draft report that concluded that dental fillings used by millions of people are safe. Yet the panel did not go so far as to declare the mercury-laden amalgam a danger, only that more study is needed because of the risk it poses to some groups

2006-09-08T20:59:00.000-07:00

FDA Again Fines Red Cross Over Blood Collection Practices
September 8, 2006

Levying the largest fine to date, the U.S. Food and Drug Administration has slapped the American Red Cross once again for failure to comply with safe blood collection techniques.

The Red Cross (ARC), which gathers 45 percent of the nation's blood supply, has been under government mandate since 1993 to improve its quality control system and ensure the safety of its blood supply.

2006-08-02T20:32:00.000-07:00

Mentholatum Voluntary Recalls Wellpatch Vapor Pads
August 02, 2006

Mentholatum announced Aug. 1 that it would conduct a nationwide voluntary recall of its WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if children chew or eat the product.

While no serious adverse events have been reported, chewing or ingesting the product could lead to symptoms ranging from a burning sensation in the mouth to seizures, due to the camphor and eucalyptus oil they contain.

The recall is being conducted with the knowledge of the FDA.

2006-08-02T20:30:00.000-07:00

State Court Order Could Help Merck Challenge Vioxx Suits
August 02, 2006

A recent state supreme court decision to review the validity of a class action claim concerning Merck's drug Vioxx could raise the bar for a national case against the company, an industry attorney says.

The Supreme Court of New Jersey decided late last week to hear Merck's appeal of the New Jersey Superior Court's decision that a national class action claim could be based on whether parties qualified under the standards of a single state's consumer fraud law. Usually courts certify a class action suit on a state-by-state basis, deciding whether the residents of that state qualify under their state's law. The New Jersey Appellate Division upheld the Superior Court's finding in a March 31 decision.

2006-08-02T20:27:00.000-07:00

Plan B Proposal Backfires on FDA; Opposition to Von Eschenbach
August 02, 2006

The FDA's proposal to approve the controversial contraceptive Plan B for OTC use has inflamed critics of the agency, leading to a number of new questions about the agency's decisionmaking and the continuation of a threatened hold against Andrew von Eschenbach's nomination to be the FDA commissioner.

The agency announced July 31 that if Barr Pharmaceuticals met certain requirements regarding the age of purchasers of its Plan B (levonorgestrel) contraceptive and undertook enforcement efforts, the drug would be approved for OTC use. However, these requirements led the agency's opponents to again question whether the FDA's decisionmaking was based on morality rather than science.

2006-08-02T20:24:00.000-07:00

Ranbaxy Invalidates Pfizer's '995 Lipitor U.S. Patent
August 02, 2006

Ranbaxy Laboratories Limited (Ranbaxy) announced today that the U.S. Court of Appeals for the Federal Circuit (CAFC) handed down a judgment in its case challenging two key atorvastatin patents held by Pfizer.

Atorvastatin is a cholesterol-lowering drug, marketed by Pfizer as Lipitor(R), and is the largest-selling drug in the world with estimated annual sales in the U.S. of USD 8.5 Bn (IMS - MAT: March 2006).

2006-08-02T20:20:00.000-07:00

Don't Eat Raw Washington Oysters, Gov't Says
August 02, 2006

The U.S. government is urging people not to eat raw oysters harvested in Washington state. The Food and Drug Administration said bacterial illnesses have sickened people.

State health officials said more than 70 cases of vibriosis have been reported this year in people who ate oysters in Washington.

2006-08-02T20:19:00.000-07:00

Journal Issues Caution About Implant Study
August 02, 2006

A study that spurred concern about high concentrations of platinum in women with silicone breast implants seems to contain flaws and should be viewed "with caution," the scientific journal that published the work warned Monday.

Questions about platinum, a heavy metal that is a fairly common pollutant, come as the Food and Drug Administration nears a final decision on whether to allow the sale of silicone breast implants.

The FDA maintains on its Web site that while small amounts of platinum can leak from implants, it is in an inert state that doesn't pose any significant risk.

2006-08-02T20:17:00.000-07:00

FDA Clears Seasonal Flu Vaccine
August 02, 2006

Vaccines that protect against three strains of seasonal influenza considered most likely to strike the Northern Hemisphere this winter have received federal approval.

The Food and Drug Administration said Wednesday that four manufacturers licensed to sell their vaccines in the United States should have 100 million doses available for the 2006-2007 flu season. Barring any changes, that record number would end years of flu shot shortages and production delays.