Dr. Angell, Former NEJM Editor-In-Chief And Current Harvard Medical School Professor, Writes An April 2009 Editorial For The Boston Globe
(Posted by Tom Lamb at DrugInjuryWatch.com)
Marcia Angell was the first woman to serve as editor-in-chief of The New England Journal of Medicine (NEJM). Dr. Angell currently is a senior lecturer in the Department of Social Medicine at Harvard Medical School, in Boston, Massachusetts.
In the April 6, 2009 edition of The Boston Globe there is an editorial by Dr. Angell titled, "Charting a new course at the FDA", wherein she offers a list of seven thing that she thinks would return the FDA to its rightful purpose, "to ensure that [drugs] are safe and effective."
Dr. Angell's Boston Globe editorial should be read in full by anyone with an interest in the drug oversight aspect of the FDA's work. As a preview, I have listed below the seven things that she would like to see Margaret Hamburg -- the nominated commissioner of the FDA -- and Joshua Sharfstein -- Hamburg's principal deputy -- do at the FDA in addition to (just) being the "new leadership".
- First, Congress should repeal the Prescription Drug User Fee Act.
- Second, consultants for drug companies should no longer be permitted to serve on FDA advisory panels.
- Third, the agency should see that the post-marketing studies it mandates are actually carried out.
- Fourth, the FDA should review generic drugs as fast as brand-name drugs.
- Fifth, Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type.
- Sixth, the FDA should stop approving me-too drugs on the basis of surrogate endpoints.
- Finally, the FDA should prohibit direct-to-consumer advertising for three years after drugs are approved.
After Dr. Hamburg has been confirmed by the Senate, I hope that she and Dr. Sharfstein will heed the guidance offered in Dr. Angell's April 6, 2009 editorial.