In yesterday’s Dispatch “No More Avastin For Breast Cancer,” ACSH's Jeff Stier proposed that the FDA expedite the drug market-approval process since “they can always reevaluate later.”
ACSH trustee and Hoover Institution fellow Dr. Henry Miller, a former top FDA official, adds:
Avastin was approved for breast cancer via FDA’s Subpart E “accelerated approval,” which was designed precisely for this sort of situation: rapid access to the market, with the understanding that confirmatory studies needed to be done and that regulators could yank the approval on the basis of new data.
Stier points out, “So the system is working. Anti-pharmaceutical critics should not be allowed to get away with their assertion that FDA approved this indication without adequate assessment.”