January 25th, 2013
Antibiotic resistance is a major concern confronting our health care system, and there is tremendous pressure on the Food and Drug Administration (FDA) to “do something” about it. Unfortunately, the FDA is responding by approving drugs that are likely to do more harm than good.
FDA advisory committees are supposed to provide independent advice from experts across the country, but recent meetings have left observers wondering whether too many FDA advisory committee members are providing neither scientific nor independent advice, and whether the committee process itself is fundamentally flawed. These concerns dovetail with essential questions about FDA objectivity and scientific judgment in its review of antibiotics.
For example, a few weeks ago, the FDA approved a new drug for multidrug-resistant tuberculosis (TB) — bedaquiline, to be sold under the name Sirturo — shortly after data reviewed by FDA scientists indicated a higher death rate for the new drug compared to the usual standard of care. The FDA’s Anti-Infective Drugs Advisory Committee had publicly reviewed the TB antibiotic on November 28, 2012.Read the rest of this entry »