In recent years, patient groups and lawmakers have excoriated the US Food and Drug Administration for not approving drugs more quickly, sometimes advocating shortcuts to the decades-old testing standards for evaluating medicines. One notable example: For the top FDA job, the Trump administration is considering a fund manager who once suggested the agency require only safety testing for new drugs.
Now, though, the FDA is pushing back.
Efficacy, schmefficacy. It’s all about connections if there is even a hint of a promise the drug works. In 1984 we received a phone call at Abbott from the White House. President Reagan was on the line, trying to help his good friend, Senator Jacob Javits, who at the time was dying from ALS. We were looking at TRH as an agent that could ameliorate ALS on a short term basis, and there were data to support it. We got the emergency shipment of TRH out to Javits, who survived another two years, although it is impossible to know how much the hormone therapy helped. This is just one example of many. This FDA report isn’t really just about the handful of Phase III failures, especially considering that Clinical Trials.gov currently lists 78,344 ongoing Phase III trials. It’s really about protecting turf and job security, which, considering Trump’s plan to whack the Federal budget is probably a valid concern.
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