Healthy Skepticism Library item: 3847

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Publication type: news

Bridges A.
FDA: Drug Companies Drop Ball on Studies
Associated Press ( here on Forbes) 2006 Mar 3
http://www.forbes.com/home/feeds/ap/2006/03/03/ap2569865.html

Notes:

Ralph Faggotter’s Comments:

It beggars belief that the FDA can be so negligent as to permit drugs to be approved for general use on the promise that safety studies will be done at a later date.

Studies which could show that the drugs were too dangerous to be released in the first place!

Full text:

FDA: Drug Companies Drop Ball on Studies
By ANDREW BRIDGES , 03.03.2006, 07:18 PM

Drug companies sometimes are allowed to hurry medicines to market in exchange for a promise to continue studying their safety and effectiveness. Those studies haven’t begun in two-thirds of cases, the government reported Friday.

The Food and Drug Administration said Friday that drug companies had pledged to conduct 1,231 drug studies. But as of Sept. 30, 797 – or 65 percent – were still pending.

“That doesn’t mean they will never be started,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.

Dr. Alastair Wood, associate dean of Vanderbilt Medical School, said if the FDA doesn’t require the studies to be done, it shouldn’t ask for them in the first place.

“It’s astonishing, really. Their job is to get the studies done and not be an apologist for their not getting done,” Wood said.

Federal regulators often grant new drugs expedited approval on condition that their manufacturers then carry out so-called “post-marketing” studies. The outcome of those studies can lead to changes in how a drug is made, prescribed and used.

Of the 797 studies still pending, commitments for 116 of them were made during the previous year. The clinical trials required under the commitments can take six months to a year to design and launch, Jenkins said.

Some studies had been agreed to years earlier, but the FDA didn’t provide a breakdown.

The pending studies represent a slight dip from the 812 still pending as of a year earlier, according to FDA documents. FDA spokeswoman Kathleen Quinn said the agency feels that “these numbers show drug companies are taking this thing seriously.”

Alan Goldhammer, of the Pharmaceutical Research and Manufacturers of America, an industry group, said the figures should not be “distorted.”

“To be clear, pending does not mean delayed. It does mean, however, that the immense and vitally important tasks of developing research protocols, finding investigators and researchers and even recruiting patients to participate in the study is in process,” Goldhammer said.

Dr. Jerry Avorn, a Harvard Medical School professor and author of “Powerful Medicines,” in which he criticizes the FDA’s post-marketing system, said the numbers show the system is broken.

“This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has ‘mandated’ drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven’t even been started yet,” Avorn said.

The FDA says it relies on the so-called Phase 4 studies to gather additional information about a drug’s safety, efficacy or use. The FDA also can require the studies after it has approved a drug, including to better determine its safe use in children.

The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as delayed and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.

The report also tallies studies required of biological products, which include vaccines, blood components and transplant tissues. There, of 321 study commitments, 118 – or 37 percent – remained pending as of Sept. 30. Another 56 were completed by that date.

“The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug – an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion,” said Peter Lurie, deputy director of the watchdog group Public Citizen’s Health Research Group.

Sen. Charles Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA added authority to require drug companies to carry out studies of their drugs once they’ve been approved and are being sold.

The FDA plans to award a contract in coming weeks to evaluate and improve the process of how the studies are developed and implemented, Quinn said.

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