Here’s a radical new idea for FDA post approval safety research

Taking a newly approved drug is not like a box of chocolates.

With a box of chocolates, you may not know what’s in the middle, but know you’re going to get chocolates. With a newly approved drug, you REALLY never know what you’re going to get.

As I’ve mentioned before, the FDA often approves drugs with known safety risks. Then the agency requires postmarketing safety research. That’s not a comforting thought for consumers. But then most people who take a new drug have no idea that safety is a secondary concern.

I recently read an article about drug company adherence to postmarketing obligations. Many companies meet their follow up deadlines. But a high percentage of them don’t.

To be honest, the article was pretty dry. But at the end, things suddenly got interesting with a proposal from a former FDA commissioner. He believes the agency should flip the approval process. That is, they should approve drugs based on safety. Then use postapproval studies to establish drug efficacy.

It’s revolutionary!

And it’s sort of odd. Just imagine your doctor saying, “Let’s try this new drug. Nobody knows if it works. But it’s safe!”

That would be a hard sell. But at the very least, it would satisfy the old medical maxim: First do no harm.

Sources:

“Drugmakers & Their Post-Marketing Commitments” Ed Silverman, Pharmalot, 3/5/12, pharmalot.com