Overheard at GMM HQ
"The FDA makes me feel like I’m speeding when I’m only going 65 mph." - Valerie, explaining why the FDA shouldn’t make us feel guilty for DTC advertising.
WHAT THE INDUSTRY IS BUZZING ABOUT
FDA RELEASES REPORT PRAISING THEMSELVES
It’s easy to be awesome when you are comparing slow outcomes from 5 years ago with today’s satisfactory speeds. That’s what the FDA did last month when it issued a report stating that investigational device exception (IDE) times have been reduced by roughly one year. How did they do it? By “applying existing authorities rather than changes to the basic framework for devices oversight that was put in place almost 40 years ago,” sayeth the FDA.
IDE review time reductions are huge, but uneven across the board. As innovation accelerates the need to bring products to market faster, it is crucial to maintain forward momentum and more positive health outcomes. Everything is not awesome.
TURNING A BLIND EYE TO BLINDING THE DOUBLE-BLIND
Try saying that ten times fast! Nothing ruins the placebo effect faster than opening up your itemized medical bill only to see the phrase “just kidding.” The Feds agree. Charging the test group, but not the control group, a copay effectively un-blinded patients allowing them to determine if they were in the treatment or control arm. Now, the Office of Inspector General (OIG) has determined that device companies can subsidize copays in clinical trials.
Conducting clinical trials can be tricky and requires flexibility. Subsidized copays help prevent contaminating the control group while also removing the barrier for lower income participants.
GOOD TO KNOW
Sorry Kim, FDA guidance is for everyone. #prescriptiondrugselfie