Congressional witch hunts make FDA officials leery of approving innovative drugs, resulting in delays and red tape that costs lives. That’s the message of two letters in Sunday’s New York Times. The first letter, from former FDA official Henry Miller, notes that FDA has become “excessively risk-averse” and unwilling to approve “innovative, high-tech products.”The second letter, from former Congressional staffer John J. Cohrssen, notes that Congressional “staff on both sides of the aisle long considered the FDA a target rich environment” for grandstanding investigations by publicity-seeking politicians.
When the FDA blocks a life-saving drug that could have saved lives, thus costing thousands of lives, Congress is silent. But when the FDA approves a drug that later turns out to have unforeseen side effects (or is alleged to be harmful by trial lawyers), Congressmen can be counted on to bring a highly-publicized, grandstanding investigation that attacks the FDA for approving the drug.
The FDA bureaucrat’s incentives are clear: delay or block innovative drugs, even if thousands of people die as a result. At least that way, you’ll avoid the wrath of Congress.