A markup you should watch that’s not on H.R. 3 ...

Congress’s effort to let the FDA actually regulate your Tylenol (also known as over-the-counter monograph reform) is finally getting a markup this Thursday. 

Congress has been trying for years to revamp the way the FDA regulates over-the-counter drugs. More specifically, it wants to set up a user-fee-based system that looks a lot more like the way the FDA currently regulates prescription drugs, rather than the antiquated system of FDA regulating via “monographs,” which can literally take decades to craft. 

There’s perhaps no greater example of the arbitrage created by the existing system than the fact that it recently took 45 years for FDA to finalize its antiseptic handwash regulations. A coalition of public health and industry groups, including the Pew Charitable Trusts and the Consumer Healthcare Products Association, highlighted that example in a recent letter to House leadership urging Congress to finally get this legislation across the finish line. 

If you’re thinking, ‘Wait, didn’t this happen like three years ago?’ ... you’re right. The House has literally passed this bill three times, but the Senate hasn’t taken it up — a number of Republicans have had “holds” on the bill that have kept it off the voting schedule. Sen. Richard Burr (R-N.C.), for example, held the issue up because he was angry at the FDA over its regulation of menthol cigarettes. Who ever said democracy wasn’t messy? 

We don’t actually know what exactly the Senate HELP committee will be marking up yet, since the bill hasn’t been introduced, but the last version the House passed back in January is a good place to start. That bill would have set up a user fee program for OTC products and granted innovative OTC products 18 months of exclusivity in exchange for going through the FDA regulatory process.