Drug-Trial Reporting Laws Need To Be Enforced

FDA Asked For Explanation

FDA / Maher Law Firm / Frank M. EidsonThe Hill (2/14, Pecquet) “Healthwatch” blog reported that Reps. Henry Waxman (D-CA), Edward Markey (D-MA), and Rep. Diana DeGette (D-CO) “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 lawmakers sent “letters to the heads of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).” The first “letter asks FDA Commissioner Margaret Hamburg to explain the delays and suggest any changes to the law that could help address the issue,” and “the other” letter “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 “applicable drug trials” within 12 months of completion.


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