A promise made. . . . Posted by Rob Schneider at 03/04/06 06:54 PM

Before a drug is approved it is generally tested on a relatively small number of people. Once on the market -- particularly in the case of a blockbuster drugs -- it may be taken by millions. So pre-approval testing is very important but doesn't necessarily provide a complete picture. It may be ambiguous whether the drug is as effective as the maker claims. Or, there may be side effects that regulators are concerned about, but not concerned enough to hold up approval.

In these cases the FDA often requires additional post-market studies. In exchange for approval now, the drug's maker agrees to conduct additional studies.

Well, apparently lots and lots of these studies are never completed though the drugs remain on the market, as reported iIn a March 3 NY Times article, New Drugs Hit the Market, but Promised Trials Go Undone.

According to the article:

Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs' approval.

The agency defended its . . . er . . . lack of oversight, with the director of the Office of New Drugs saying that

many drug companies who promised to undertake trials "are taking that commitment very seriously."

Dr. Jenkins emphasized that only 5 percent of the promised drug trials were officially considered "delayed." In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for the tests.

And the deputy commissioner, Dr. Scott Gottlieb, said the FDA would ask for an external evaluation -- but it may take a year.

Apparently:

Although the controversy about these numbers has raged for years, the ratio of uncompleted trials has remained largely unchanged. In 2002, the first year that the F.D.A. began closely monitoring the issue, 820 of 1,339 promised trials, or 61 percent, were "pending."

Here's an external evaluation of the FDA that won't take a year: 61 percent of your post-market studies are pending.

The article notes that studies sometimes are difficult to complete and that they are expensive -- it also notes that drug companies have little incentive to do the studies. The FDA has few tools to require them to complete the studies and not a terribly strong a will to jawbone drug makers into completing them.

Dr. Alastair Wood, associate dean of Vanderbilt medical school, said the F.D.A. needed to get tougher on drug makers. "Who would turn in their homework if they didn't have to?" Dr. Wood asked.

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