Senators: FDA Pulled Reviewer Off Glaxo Drug
From Reuters
Excerpt: A senior Food and Drug Administration scientist has told congressional investigators that the FDA removed him or her from work on GlaxoSmithKline Plc's drug Avandia after voicing concerns about the safety of the diabetes pill, two senators said on Tuesday.

The unnamed FDA medical officer at one time was the primary reviewer for Avandia, according to a letter sent to the FDA by Senate Finance Committee Chairman Max Baucus, a Democrat, and Sen. Charles Grassley, the panel's top Republican.

The scientist has believed since 2005 that there was enough evidence for a strong "black box" warning on Avandia about a risk of congestive heart failure, the senators said.

In a statement titled "Senators reveal effort by the FDA to suppress scientific dissent and downplay safety concerns" released with their letter, they said the reviewer was "sidelined after voicing safety concerns" about Avandia.
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Labels: corruption, FDA

FDA Rules Override Warnings About Drug
Cattle Antibiotic Moves Forward Despite Fears of Human Risk
From the Washington Post

Excerpt: The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.

Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh the threats to human health posed by proposed new animal drugs.
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Labels: agency, FDA, health

FDA Budget Malnourished
From the Los Angeles Times
Excerpt: WASHINGTON — When scientific advisors urged the Food and Drug Administration in February to put a strong warning about suspected cardiovascular risks on attention-deficit drugs taken by millions of children and adults, agency officials said more clinical evidence was needed.

Now, the FDA-funded study meant to authoritatively answer questions about the drugs for attention-deficit hyperactivity disorder may be halted in midstream. The reason: The agency doesn't have the money to finish it.

The threat to the study, as revealed in documents and interviews, stems from chronic shortchanging of the nation's drug safety program. It is one symptom of a federal agency increasingly constrained by a budget that has failed to keep up with costs. This crunch is even more dire in the food division, which tries to keep tainted foodstuffs from supermarket shelves.

Even as concerns grow, the agency has budgeted only $1.6 million for such safety studies of medications already on the market, and that number is scheduled to drop to $900,000 in the coming year. Outside experts estimate that the agency needs $20 million to $100 million a year to conduct such studies.

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Labels: agency, drug safety, FDA, food, health

FDA Tries to Limit Drug Suits in State Courts
From the Washington Post
Excerpt: People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement. ...
... "It's a typical abuse by the Bush Administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," he said in a statement.

The Bush administration has intervened in a number of state liability cases against drug and medical device manufacturers with friend-of-the-court briefs supporting the companies. Yesterday's policy statement was just a way to make the same points on a broad and general basis, Gottlieb said. More

Labels: agency, bush, FDA, health, law