FDA Commissioner Scott Gottlieb, MD, unveiled his plan to slow drug price increases, in part by making it easier for generic drugs to be approved and increasing competition.
In an appearance before the House appropriations subcommittee, which is deciding on the FDA’s budget for next year, Gottlieb said his Drug Competition Action Plan would make it easier for generic drugs to enter the US market by accelerating the FDA’s review process, which has a current backlog of over 2600 applications. Gottlieb also called for a simpler approach to reviewing applications for biosimilars of complex biologic drugs, including Sanofi’s Lantus insulin and Mylan’s EpiPen. Gottlieb has previously advocated a faster path to marketing new and generic drugs.
Gottlieb’s plan might also receive a boost from the lift of the hiring freeze on the FDA, which came to light during the hearing.
Acknowledging that the FDA does not play a direct role in drug pricing, Gottlieb said the agency can take steps to facilitate entry of lower-cost alternatives to the market and increase competition. Stating that legislative action would be needed to overhaul the drug approval process, Gottlieb noted that among the actions the FDA could take was reviewing situations in which brand-name drug makers try to slow approval of generic competitors. Both the Senate and House have introduced bills that would allow generic drug makers to sue brand counterparts.
Gottlieb also said that the Risk Evaluation and Mitigation Strategy (REMS) program, which allows the FDA to require drug makers to prove that a drug’s benefits outweigh its risks, was being manipulated by the pharmaceutical industry and used to slow the introduction of generic competition. He said the FDA was evaluating whether to waive REMS requirements more easily than the agency has in the past.
Bloomberg notes that drug companies with older and competition-prone medications, more than firms with newer drugs, will have more to fear from faster generic approvals and changes made to the legal and regulatory tactics that are used to extend a drug’s sale period. Companies that rely on biologics—which are among the bestsellers worldwide but that have faced little or no generic competition in the United States—will also be more concerned with such changes. If biosimilar approvals speed up, the biggest losers may be specialty pharma, which tend to have older products and smaller markets.
A spokesman for the pharmaceutical industry group Pharmaceutical Research and Manufacturers of America said the group is committed to working with the Trump administration and Congress on market-based reforms that would encourage generic competition and promote biopharmaceutical innovation.
President Trump’s 2018 budget proposal for the FDA seeks a last-minute renegotiation of user fees to make up for an approximate 30% decrease in the FDA’s budget. The President’s call for over $1 billion in new user fees to replace losses from his proposed budget cuts was made even though the House and Senate have already both agreed upon their respective versions of user fee reauthorization legislation that contain the user fees already agreed to by the FDA, the pharmaceutical industry, generic drug and biosimilar makers, and medical device manufacturers.
Senator Lamar Alexander (R-TN) told HHS Secretary Tom Price that it was too late for the Trump administration to have an impact on this year’s user fee reauthorization bills. Industry group representatives including BIO and AdvaMed told Senate officials that a failure to act on the already agreed-upon reauthorizations would be devastating.