The New FDA commissioner, Scott Gottlieb, has announced several strategies for lowering drug costs. President Donald Trump made fighting the high cost of pharmaceutical drugs a key part of his campaign, and now he’s tasked his new FDA commissioner with implementing policies that would help the agency tackle high prices.
It is important to note that the FDA does not have the authority to regulate drug prices on its own, as some other governments and regulatory agencies around the world have. Instead, the FDA must consider measures that increase competition and thus lower drug prices with market based solutions.
One of the strategies commissioner Gottlieb outlined in a budget hearing with the US House of Representatives was a new FDA initiative where the agency will publish and update a list of drugs that are off patent and currently have no competition. Gottlieb also said that the agency is looking to simplify the generic review process and to eliminate the backlog of generic drugs waiting for review. Those moves would increase competition and theoretically lower drug prices over the long term.
The FDA has also said it is looking to end misuse of the Risk Evaluation Mitigation Strategies program which has limited generic drug producers’ ability to get samples of branded drugs needed to develop generic versions.
With little legislation moving through Congress and a public that is bitterly divided on partisan lines, the FDA proposals are likely to be some of the only strategies for lowering US drug prices in the near term. FDA law firms, generic companies, and other parties are likely to consider what moves to make to maintain profitability under new FDA strategies.
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