FDA to take tougher line on fast tracked drugs

This is a welcome development!  The FDA has had a priority of releasing drugs and medical devices on an unsuspecting public before they’ve really been tested thoroughly.  Drug companies pay the FDA, and it’s a big source of their funding.  They’re well aware that once a drug is released they’re hard to pull them back so they are eager to release them early.  I talk about this in my Do No Harm Chapter.  Wait seven years before trying new drugs!  Wait for seven years!

The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG and other drugmakers to remake plans for their drugs or pull them from the market.

Under the accelerated-approval program, the FDA clears the use of prescription medicines faster than it normally would. The agency relies on preliminary data to make the decision, but asks companies to conduct follow-up studies to confirm that the drug works.

Yet companies haven’t always done the studies—or been willing to pull drugs when a follow-up study failed to show a true benefit.

In recent weeks, the agency has taken action, prodding GSK to withdraw a blood-cancer drug after it failed a follow-up trial, and announcing that Viatris Inc. stopped selling a burn treatment because the company never finished its confirmatory study.

Meantime, the FDA told ImmunoGen Inc. and ADC Therapeutics SA, which have been developing cancer drugs, that it wouldn’t grant the speedy approval until they had begun follow-up studies, the companies said.

“The message from the agency is we want to see, you know, meaningful progress on your confirmatory study,” said ImmunoGen Chief Executive Mark Enyedy.