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FDA Disappoints Lung Transplant Patients
Gottlieb notes that criticism of the FDA is expected by the FDA’s internal reviewers, who have some insulation from political pressure. The FDA’s outside advisory committees, on the other hand, are much more likely to hedge their recommendations to protect themselves from public criticism.
…a series of lopsided votes from the agency's outside advisory committees to turn down otherwise promising new drugs leaves the overwhelming impression that the criticism has cast a darker shadow of caution over these outside advisors than even over rank-and-file FDA staff.
The latest came on Monday with a stunning split decision on an effective new medicine called Pulminiq to prevent rejection in lung transplant recipients, a condition that is fatal in more than half of all cases once the malady sets in.
That the advisory panels would be the first to grow skittish seems to make sense. It is one thing when the media and Congress go after rank-and-file FDA reviewers and agency hands. Most people who work at the FDA expect the criticism, and there are many institutional protections built into the agency that shield its professional staff from gratuitous attacks.
But members of the FDA's outside advisory committees, who are drawn from the ranks of academic medicine, are rewarded for serving only by the enhancement to their reputation, and don't have similar protections or expectations.
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