House Dems call on health agencies to enforce drug-trial reporting laws

A trio of House Democrats on Tuesday raised concerns with federal health agencies' enforcement efforts after a British medical journal reported that drugmakers "routinely fail" to publish the results of clinical trials within the timeframe required by law.

The study in BMJ found that only 163 out of 738 trials — 22 percent — covered by federal reporting requirements were disclosed in accordance with the law in 2009. 

In letters to the heads of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the lawmakers argue that the "publication delays may allow ineffective or dangerous drugs to remain on the market, resulting in significant harm to patients and waste in the health care system."

One letter asks FDA Commissioner Margaret Hamburg to explain the delays and suggest any changes to the law that could help address the issue. The other, to NIH Director Francis Collins, asks if his agency has "adequate resources and authority" to implement the requirements of the Food and Drug Administration Amendments Act of 2007, which requires publication of a results summary on clinicaltrials.gov for all "applicable drug trial(s)" within 12 months of their completion.

The NIH is responsible for maintaining the public database of drug trial results, while the FDA is responsible for enforcing the statutory drug trial reporting requirements.

The law "was enacted in response to similar reporting failures that contributed to dangerous or ineffective drugs remaining on the market far longer than they should have," the letter points out. "The new study suggests this underreporting is continuing today."

The letter was signed by Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.), the top Democrats on the Energy and Commerce and Natural Resources committees, respectively, and Rep. Diana DeGette (D-Col.), ranking member on the Energy and Commerce oversight subpanel.

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