FDA Probes Shine Harsh Light on Pharma Biz

It must be awful to work at the FDA right now. There you are, sitting in your cubicle, trying to make sure the pharmaceutical industry cures more people than it kills. But every five minutes some investigator from the Government Accountability Office calls you into the conference room for a "word" about how you do your job.

Perhaps not every five minutes, but that's what it must feel like according to this story in the Wall Street Journal. There have been 20 investigations into the FDA launched by Rep. John Dingell (D-Mich.) and Sen. Chuck Grassley (R-Iowa) and their colleagues.The pair want to overhaul the agency in 2009, when the Democrats are more likely to control Congress and the White House.

The story doesn't describe many of those probes, or their results, so I went digging. It turns out that the probes shine as much negative light on the industry as they do on the FDA. Here's a selection:

Drug advertising is out of control: "FDA's oversight has not prevented some pharmaceutical companies from repeatedly disseminating ... misleading advertisements for the same drug, and some pharmaceutical companies have failed to submit all newly disseminated advertisements to FDA for review."

Post-market monitoring of drugs such as Arava, Baycol, Bextra, and Propulsid is slipshod: "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints. ... There is a lack of criteria for determining what safety actions to take and when to take them."

Most illegal off-label drug promotion goes undetected: If the FDA sends warning letters to offending companies, it takes "an average of 7 months to issue these letters from the time it [FDA] first drafted them. In addition, drug companies that were cited for more serious violations took an average of 4 months to take the corrective actions requested."

Foreign drug manufacturing plants don't get inspected much (a major problem given that most major pharma companies offshore their manufacturing): "FDA had difficulties in determining whether the scope of other countries' inspection reports met its needs and these reports were not always readily available in English. ... FDA inspected relatively few foreign establishments each year. ... the agency still inspects far fewer of them than domestic establishments."

The approval of next-day contraceptive Plan B for over-the-counter was a political mess: "The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval. ... there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them ... FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B ... GAO found that high-level management's involvement for the Plan B decision was unusual for an OTC switch application and FDA officials gave GAO conflicting accounts about when they believed the decision was made."

Drug companies don't provide enough data on how drug affect elderly people, and the FDA doesn't check this out enough: One third of new drug applications don't include a discussion of drug safety in the elderly, who process drugs more slowly than younger people. Plus, "We found that about [only!] one-quarter of the medical officer clinical review summaries that we reviewed documented the medical officer's review of the sufficiency of representation of elderly persons."

And these are only the investigations that are finished. Coming down the pike are battles over whether the FDA should oversee imported drugs and new generic pills.