FDA and NIH Not Talking About Critical Program

ClinicalTrials.gov is considered by many to be critical to the transparency and effectiveness of medical research.  It’s a database at which many clinical trials are supposed to be registered.

But last year a review said most studies that are supposed to report, don’t.

NIH and FDA said the numbers aren’t that bad but they have not released analysis indicating what the numbers are.

Meantime, the agencies have not published the rules Congress called for in 2007 legislation to enhance enforcement. Last year NIH told Congress it anticipated the rules would be out by the end of the year.

Now NIH and FDA aren’t answering questions. In January public information officers refused to let me speak to anyone over the course of eight contacts I made with them. An NIH official adamantly refused to tell me anything on the phone and an FDA official did not return my calls, sending refusals through the public information officers.

FDA public information officers said, “From our perspective it would be inappropriate to discuss or speculate on a process that is incomplete,” and, “Regulatory actions take time.”

Kathryn Foxhall

Freelance health reporter

Washington, D.C., area