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Investing.com -- The U.S. Food and Drug Administration (FDA) has laid off a significant number of its senior negotiators, who were involved in discussions with the pharmaceutical industry regarding the renewal of user fee programs. These programs are crucial for funding the FDA’s drug review system, according to Reuters, citing six sources familiar with the situation.
The layoffs included 15 staff members who were preparing for the upcoming renewal discussions scheduled for 2027. The user fee program involves agreements where pharmaceutical and generic drug companies finance the FDA’s review of their products. These agreements are supervised by Congress.
The dismissals have caused disruption in the process of reauthorizing these agreements, several experts told Reuters. They also suggest that the loss of these FDA employees could jeopardize the agency’s preparations for the reauthorization process of the program that funds its budget for one of its core functions, which includes reviewing potentially life-saving drug products and approving treatments that are safe and effective.
Pharmaceutical (TADAWUL:2070) and medical device companies rely heavily on the predictability offered by these user fee agreements. Under these agreements, the FDA commits to completing new drug reviews within either 10 months or 6 months, depending on whether it is a standard or priority application. The layoffs at the FDA could potentially give the industry an upper hand in the upcoming talks, experts have noted.
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