Politics enters the drug approval process

Some politics might have sometimes been in the FDA approval process. A good example of that may have been with breast implants. But now there will be a new clear dimension: did they reject a drug because it really wasn't effective or because the FDA panel just didn't think that the drug was worth its cost? The latest prime example is: Avastin for the treatment of breast cancer. Cost-benefit calculations are always important, but let patients and insurance companies figure this out, not the government. This post by sometimes NY Times writer Jessica Wapner observes that financial considerations might have been involved in the panel's rejection of the drug, but doesn't really address whether the government cost concerns could lead to the rejection of drugs. From Human Events:

In a sign of things to come, members of the Food and Drug Administration’s Oncologic Drugs Advisory Committee voted Wednesday to reject an appeal of its December 2010 recommendation that the FDA withdraw its sanction of Avastin for treatment of breast cancer.

The day before, in what now seems futile, advocates for the drug rallied at the FDA headquarters in Silver Spring, Md., with signs, chants and a folk singer.

Blocked by a team of Homeland Security police officers in combat uniforms, the nearly 100 pink-shirted protesters massed in front of the entrance to the agency's campus demanding it continue to approve Avastin for metastasized breast cancer. . . .



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