FDA Corruption, part the 98787

Yes, yes, it's all a big joke, at the expense of consumers who end up taking drugs that should never have made it to the market because of untested risks. Meanwhile, by the time enough people die, or suffer debilitating side effects, the drug manufacturers have reaped large profits, and the FDA regulators now have left the FDA, and work as consultants for Big Pharma. Everybody gets rich, the public gets screwed, rinse, repeat. Disgusting.

WSJ.com - Drug Makers Seen As Slow to Finish Postmarket Studies: By JENNIFER CORBETT DOOREN
Pharmaceutical companies haven't completed about half of the studies ordered by the Food and Drug Administration as part of the agency's accelerated-approval system for new drugs, according to a congressional-staff review.

The review, by Rep. Edward J. Markey (D., Mass.), focused on the accelerated-approval program, which requires pharmaceutical companies to continue studying an approved drug after it goes on the market.

FDA spokeswoman Suzanne Trevino said agency officials couldn't comment on the report because they hadn't seen it. “Accelerated approval has an important role and gives earlier access to life-saving medicines,” she said.

Using FDA and Securities and Exchange Commission data, the Markey staff looked at 91 studies ordered on 42 products that were approved from 1993 to October 2004. The FDA's accelerated-approval process was established in 1992.

Of the 91 studies, 46 have been completed, 42 haven't and three have been delayed. Half of the unfinished studies are yet to begin. The oldest outstanding study was ordered in 1996 for a Shire Pharmaceuticals Group PLC drug used to treat a small group of people who faint as a result of low blood pressure. A Shire spokesman said the company acquired the marketing rights to the drug in 2000 and agreed to do two studies, one of which is completed and the other is continuing.

The Markey review also found that 68% of the companies didn't disclose with the SEC that they were required to conduct studies. It is unclear if companies were required to divulge that information. SEC regulations require firms to disclose “material” information to investors.

“It is outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required postmarketing studies,” Mr. Markey said. “They are laughing at the FDA, and sometimes it seems as if the FDA is treating it as a joke as well.”

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