Speeding up FDA Approvals Calls for Pause
It's an election year so it's not surprising to learn that politicians are floating new ideas—some good, some bad—to fix the system and garner a little media attention for themselves.
First in line is Sen. Ted Cruz (R-TX, below), a man with little to no experience in healthcare, except perhaps through meeting industry lobbyists during his personal fund-raisers.
If you predicted that the senator's plan for the FDA involves “streamlining” the approval process, then give yourself a pat on the back. Specifically, he wants to negate any need for the FDA to evaluate products that are already on the market in foreign countries. Once approved somewhere on the planet, the FDA then has 30 days to pull the trigger on its own decision—giving the drug a thumbs-up or -down.
See also: FDA Policy: Is Off-Label on the Table?
The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further. If Congress is not happy with the FDA decision, they can override that decision with a majority vote. Placing congressional staffers in the position of making such decisions moves this proposed legislation beyond silly to simply dumb.
Dumb and dangerous.
Cruz has likely succeeded in gaining attention for his ideas, and they probably sell well at campaign events where few people understand complicated medical science. But anyone who relies on drugs and expects them to be somewhat safe should be alarmed. And that includes the lobbyists supporting his run for president.
Paul Thacker is a journalist and adviser to nonprofits.