Food and Drug Administration Commissioner Scott Gottlieb says he’s not looking to shame brand-name drug companies into providing generic drugmakers with the samples they need to create copies. It’s hard to see what else he has in mind by publishing a list of companies that generics makers say aren’t playing ball.

If pushing the big pharmaceutical companies to allow more competition from generics is indeed his goal, it’s a good one. Getting generic medicines to market faster could go a long way toward lowering exorbitant drug prices in the U.S. But whether Gottlieb’s effort to shine daylight on the companies’ “shenanigans,” as he puts it, will work is an open question.

It would be more effective to empower generics makers to sue brand-name drug makers who resist or delay selling them the thousands of samples they need to create and test copies. Bipartisan legislation to do just that has been stalled in Congress, opposed by the powerful pharmaceutical lobby.

Now, in the wake of President Trump’s recent promise to boost competition in the drug market and Gottlieb’s efforts on generics, Speaker Paul Ryan says a revised version of the bill may soon move forward in the House. He and Senate Majority Leader Mitch McConnell should see that the legislation is passed without delay.

Brand-name drugs are expensive because they are protected from competition by the FDA and the U.S. Patent Office for anywhere from eight to over 15 years. A 2016 Harvard Medical School study found that this is the No. 1 reason drug spending has risen so much in the U.S. – by 164 percent from 2008 to 2015.

Slowing the creation of generic drugs is not the only way that big drugmakers endeavor to extend their brand-name monopolies. But it is one that lawmakers can readily address by ensuring that generics makers can create copies at the earliest possible opportunity.


Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.

Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.

filed under: