The FDA’s own actions are also jeopardizing innovation. In fact, they are endangering American lives as well. We have already seen a significant drop in the number of drug approvals granted: phase 1 clinical trial approval rates currently run 1 in 10, compared with 1 in 5 before 2004). Even worse, though, is what looks unmistakably like the Obama FDA's foray into health care rationing.
Avastin, a cutting edge biologic that cuts off blood supply to tumors, has been at the center of a high-profile battle with the FDA since the agency granted the drug approval for treating breast cancer in 2007.
Based on its performance in several clinical trials, Avastin was shown to promote months and in some cases years of "progression free survival" in late-stage breast cancer patients. In spite of this and the fact that it is prescribed annually to 17,500 women for breast cancer, last December the FDA reversed its decision and revoked Avastin's approval.
One reason for the reversal was likely Avastin's high price tag, as it costs about $8,000 per month. Without FDA approval as a breast cancer treatment, insurance companies are unlikely to pay for it, leaving the women who depend on it on their own. The FDA's final decision on Avastin will come this summer, after the drug's manufacturer exhausts its appeals.
To mask its intentions, the FDA changed its metric for approval mid-deliberation. In 2007, prolonging life was the standard; in 2010, prolonging life for a "clinically meaningful" period of time replaced it. What that duration of time is, specifically, the FDA failed to mention in its decision.
This unilateral and subjective switcheroo has drugmakers concerned. Should they be sinking billions into future Avastins only to find FDA approval revocable on rationing grounds?
Moreover, under the FDA’s fast-track approval process, preliminary research can green-light a drug contingent on its developer submitting follow-up research confirming the original findings. What’s now to stop the FDA from changing metrics in the middle of fast-track approvals as well?
If the president is as committed to innovation as he claims, he could start by looking at the ways his own proposals and his own bureaucrats are undermining it.
Sally C. Pipes serves as a health care advisor to The Rudy Giuliani Presidential Committee. She is President and CEO of the Pacific Research Institute. She is author of Miracle Cure: How to Solve America’s Crisis and Why Canada Isn’t the Answer.
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