Congress hasn't made any progress on drug pricing legislation, but that hasn't stopped the government from acting. Now, FDA Commissioner Scott Gottlieb has unveiled yet another move to step up competition in the generics business.
After previously announcing several strategies to bring copycat drugs to market more quickly, Gottlieb now says the agency will prioritize applications for generics that could launch immediately after a first-to-market copy loses its 180-day exclusivity.
Though the first generic tends to be cheaper than the brand, the real pricing relief comes after multiple copies launch. Under generic approval rules, the first company to file for FDA approval gets a 180-day lock on the market, and that means the pricing battle waits till that period expires. Gottlieb wants to make sure the competition doesn't wait further, by lining up other copies for approval.
The news comes after the FDA earlier this year unveiled its Drug Competition Action Plan. Back in May, Gottlieb said the FDA would publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allow companies to extend monopolies.
All of those moves, Gottlieb has said, could help to tackle high medicine prices. And the effort is showing: so far this year, the FDA has approved a record number of generic drugs, according to Regulatory Focus, topping a previous record set last year.
Addressing the regulatory "gaming" issue, the commissioner last week said it's time to "end the shenanigans" of Risk Evaluation and Mitigation Strategies abuses that hurt the ability of generics companies to develop cheap copycats. The FDA will work with supply chain companies to make sure generic companies can get their hands on needed samples, and unveil further strategies in the coming weeks, Gottlieb said at a Federal Trade Commission workshop.
Moves at the FDA to increase competition come after a two-year firestorm against the drug industry for its pricing. Many lawmakers in Congress have floated ideas to address the issue, but no proposals have gained steam. In the absence of reform in Washington, many states have taken the issue into their own hands.
California, Maryland and Nevada have enacted laws that seek to tackle the pricing issue in individual ways, while voters in Ohio just rejected a ballot initiative that would have limited prices for state agencies to those paid by the U.S. Department of Veteran's Affairs. Ohio voters rejected the proposal by nearly a 4-1 margin.
President Donald Trump, for his part, has railed on the pharmaceutical industry and its prices, but critics contend his administration's actions and proposals have favored industry. On Monday, the president nominated former Eli Lilly executive Alex Azar to run the Department of Health and Human Services.