PDUFA

How the FDA will spend your fees

Thu, 08 May 2008 06:59:55 -0400

Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. The agency would spend the to boost the number of employees looking at new scientific approaches to drug safety, improving adverse event detection and prevention programs, and cutting back on medication errors. Plus, it would invest millions in epidemiology "best practices" and data acquisition. Want more detail? Check out the plan itself on the FDA website.

- see the plan
- check out the story at FDA News

FDA mulls behind-the-counter drug sales

Thu, 04 Oct 2007 06:59:57 -0400

Once, the gap between prescription drugs and over-the-counter sales was a wide No Man's Land where few products roamed. Now, the FDA may settle more medications in this country, known as behind-the-counter (BTC) sales, in part to improve access for the uninsured.

The agency is seeking public comment on the potential move, which would allow patients to buy certain remedies after consultation with a pharmacist. Though the FDA won't cite specific meds that might be included, experts cite birth control pills and cholesterol-lowering remedies as possibilities.

- see the AP article

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FDA jobs won't be farmed out

Mon, 01 Oct 2007 06:59:55 -0400

Some FDA staffers can breathe a sigh of relief: Their jobs won't be farmed out to the private sector, the agency says. The FDA has decided not to outsource a batch of 77 workers, but there are nine more cost-benefit studies ongoing that could lead to privatizing some FDA administrative functions.

Earlier this year, the agency mounted 13 studies to determine whether it could save money by outsourcing work done by some 320 FDA employees. With the result of four of those studies in, 77 workers have been told they'll keep their jobs. The remaining research is expected to be complete by January.

- read the AP article

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Pharma, FDA to study adverse events

Thu, 27 Sep 2007 06:59:58 -0400

When it comes to predicting who'll suffer severe drug side effects, seven heads are better than one. Such is the hope of a Big Pharma consortium formed to track down genetic risk factors for serious adverse events.

The group--which comprises Pfizer, Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Roche, Sanofi-Aventis and Wyeth--will pool their data on Stevens-Johnson syndrome, a rare but potentially fatal drug reaction, and liver toxicity. Both side effects occur infrequently, but can be caused by multiple drugs.

Theoretically, it's more evidence of the Brave New World of personalized pharma. But would every patient prescribed a potentially risky drug get the right genetic test? Or would sifting out the vulnerable patients have to wait until we're all carrying ID cards embedded with our personal DNA?

- check out this release for details on the program
- read the New York Times article

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FDA taps new-yet-old drug chief

Mon, 24 Sep 2007 06:59:57 -0400

As the ink was still drying on the new drug-safety bill, FDA shuffled its management, bringing back Janet Woodcock as director of the Center for Drug Evaluation and Research. The previous director, Steven Glason, will take over as acting Surgeon General October 1.

Woodcock held the reins at CDER for more than 10 years before becoming deputy commissioner. She'll need that experience to take on the safety overhaul ordered by Congress--which involves a bigger budget, more power, and lots more responsibility to seek out unsafe drugs before a Vioxx-like disaster strikes.

- see the FDA commissioner's statement
- read this piece from The Wall Street Journal (sub. req.)

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Final FDA bill lacks new DTC oversight

Fri, 21 Sep 2007 06:59:55 -0400

The Senate overwhelmingly passed the drug-safety and FDA funding bill yesterday and sent it along to President Bush for his signature. Experts are calling it a sea change in the FDA's operations. Instead of waiting for reports of adverse events to roll in, the agency will be on the prowl for evidence--digitally, through its new surveillance system and clinical trials database, and non-digitally, by ordering post-approval trials. Questions: Will the agency figure out how to separate false alarms from real read flags? Can it target its post-approval trials appropriately? There's nothing to do but watch and wait.

Interestingly, the final version of the bill is a bit toothless when it comes to regulating drug ads. Apparently, the media industry helped pharma fight provisions that would have allowed the FDA to force changes in direct-to-consumer advertising. Now, the agency will only be able to recommend them.

- read the analysis in the Los Angeles Times
- read this Wall Street Journal article on the media's pro-DTC lobbying

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House overhauls, passes PDUFA

Thu, 20 Sep 2007 06:59:58 -0400

Congress kicked their work on an FDA funding bill into gear--after the FDA commissioner gave them a kick in their collective pants. The commissioner threatened to lay off workers if the agency didn't get its funding by tomorrow's deadline, so the House scrambled to approve a measure that would boost FDA funding and revamp its drug-safety system. The bipartisan compromise bill still awaits approval by the Senate.

The renewed PDUFA would increase the fees paid by drug and device makers when they submit products for approval. And it would boost the FDA's power to monitor drugs after they're put on the market. The agency could order companies to perform clinical trials, for instance, and could issue warnings earlier than it could before.

The bill also sets up a high-tech surveillance system to try to spot safety problems earlier, and, as expected, calls for a public-access database of all clinical trials. So hold on to your pink slips, Mr. Commissioner. It looks as if you'll get your money.

- see this statement from the bill's lead author, Rep. Frank Pallone (D-NJ)
- read the story from the Los Angeles Times

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