On May 25, FDA Commissioner Scott Gottlieb told House lawmakers that the Food and Drug Administration intends to take steps to lower drug prices by increasing generic drug competition.
Gottlieb announced the FDA hiring freeze placed on the agency by the Trump administration is over, and that the FDA will have clear and more frequent communication with developers of generic drugs in order to make the review process more efficient. Generic drug makers will also have access to additional information in regards to the pursuit of development programs as the FDA will publish a list of drugs with no generic competition and that are off patent.
The head of the agency also said that, while the FDA doesn’t have a direct role in the pricing of drugs, the agency can increase competition by implementing measures to facilitate entry of cheaper alternatives to the market. Gottlieb said “Simply put, too many patients are priced out of the medicines they need.”
REMS (risk evaluation and mitigation strategy) is another area being evaluated by the FDA in an effort to streamline the process. While REMS are often shared by brand companies and generic applicants, brand companies have been known to delay negotiations with generic companies on shared REMS in an effort to keep the generic company’s product off the market. The FDA is working to determine whether the shared REMS can be waived more often than has occurred in the past in an effort to speed what has been known to be a slow and often tedious process.
Soaring prescription drug prices have made headlines in the news in recent years, as more consumers find they cannot afford the medications they need to treat diseases/conditions or even extend their lives. Time will tell whether the FDA’s efforts will have an impact on drug prices.
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