Importantly, the FDA cannot regulate drug prices; however, it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.
At a U.S. House of Representatives budget hearing on in May, new FDA Commissioner Scott Gottlieb said his Agency will 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 allows companies to extend patent monopolies. On the first point, Gottlieb said a regularly updated list of off-patent meds could “entice competitorsa into the market” and ultimately lower costs. One such old, off-patent med with no generic competition is infamous to industry watchers: Daraprim.
Back in 2015, after picking up the medication from Marathon Pharma, Martin Shkreli’s Turing Pharma raised Daraprim’s price exponentially, triggering intense backlash.
In his opening remarks at the budget hearing, Gottlieb said he is working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.
The FDA will work to “improve processes that enable generic versions of complex drugs to be approved for marketing,” and simplify the overall generic review process, Gottlieb said. He wants the agency to achieve those goals while “completely eliminating” a backlog of generic medications waiting for a review, he told members of Congress. Furthermore, the FDA will seek to stop misuse of Risk Evaluation Mitigation Strategies that have hurt generic drug developers’ ability to get samples of branded medications needed to develop copycats.
The proposals will likely be welcomed by those who’ve asked for drug pricing reform but have seen little action from Congress despite more than a year of calls from its members to rein in drug prices.
In a May statement, the pharmacy benefit manager industry group PCMA hailed the proposals. “As the Trump administration seeks to combat high drug costs, we applaud FDA Commissioner Gottlieb’s decision to publish a ‘watch list’ of off-patent drugs,” PCMA CEO Mark Merritt said in a statement. “This move, which PCMA and others have long advocated, will help deter manufacturers from buying the rights to drugs like Daraprim for the explicit purpose of raising their price.”
Shortly after winning the U.S. presidential election, Donald Trump said pharma has been “getting away with murder,” but has moderated that tone in subsequent meetings with industry leaders.
Proposals floating in Congress to fight drug costs include Medicare price negotiations and importation from Canada.
REFERENCE: Fierce Pharma; 26MAY 2017; Eric Sagonowski