The Food and Drug Administration is looking at ways to speed up the approval of generic medicines, part of a Trump administration effort to lower drug prices.
Newly installed FDA Commissioner Scott Gottlieb told a congressional panel on Thursday that the agency is crafting a “drug competition action plan” aimed at expediting approval of generic versions of brand-name medications that lack competition.
Gottlieb, who was confirmed by the Senate on May 9, acknowledged that legislative action would be required to overhaul the drug approval process. But Gottlieb would like the FDA to take a more active role in pricing, which he said would include reviewing instances in which brand-name drug makers try to slow the approval of generic competitors.
Identical bills have been introduced this year in the House and Senate that would enable a generic drug maker to sue its brand counterpart.
“While FDA does not play a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market and increase competition,” Gottlieb said Thursday in testimony before a House Appropriations subcommittee. “This is especially true when it comes to safe and effective generic medicines.”
Key to the FDA effort will be responding to efforts by brand-name drug makers to use safety regulations to slow the introduction of generic competition, he said. Gottlieb said the Risk Evaluation and Mitigation Strategy, which enables the FDA to require a manufacturer to prove that the benefits of a drug outweigh its risks, was being abused by the pharmaceutical industry. He added that the FDA plans to announce a public meeting to “solicit input on situations where manipulation occurs.”
“FDA has an important role to play in preserving the balance between innovation and access and making sure its statutory and regulatory processes are working as intended and not being manipulated in ways that FDA and Congress didn’t intend,” Gottlieb said.
Gottlieb, a former deputy FDA commissioner, said he also wants to improve the process for approving generic versions of “complex” drugs such as EpiPens, which consist of an old medication that has a new delivery system. Another step the FDA will take, he said, is to publish a list of drugs that are off-patent and lack generic competition.
Andrew Powaleny, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug trade group is “committed to working with the administration and Congress on market-based reforms that encourage generic competition and promote biopharmaceutical innovation.”