美媒：FDA混乱局面威胁美国医疗创新及患者健康

Core Viewpoint - The FDA is facing significant internal turmoil and criticism, which threatens the timely approval of new drugs and therapies, potentially jeopardizing the U.S.'s position as a leader in biomedical innovation [1][5]. Group 1: Internal Conflicts and Leadership Issues - George Tidmarsh, the former director of the FDA's Center for Drug Evaluation and Research, resigned amid investigations into his social media posts that suggested toxicity in an FDA-approved lupus treatment [1]. - Tidmarsh claims he was retaliated against for questioning a new expedited drug approval process, while the chairman of the company selling the drug has filed a lawsuit against him for alleged retaliatory actions [1]. - Vinay Prasad, the head of the FDA's vaccine and biologics division, has been accused of fostering a toxic workplace culture, leading to the departure of at least seven senior executives [2]. Group 2: Impact on Workforce and Morale - The management chaos at the FDA has severely impacted employee morale, with many staff members feeling overworked and underappreciated, leading to a significant talent drain [3]. - The FDA has struggled to fill vacancies, with high-level scientists questioning why talented individuals would choose to work there instead of pursuing more lucrative opportunities elsewhere [3][4]. - Employees report a pervasive atmosphere of fear regarding retaliation, which has contributed to a challenging work environment [2][3]. Group 3: Consequences for Innovation and Investment - The instability within the FDA is causing investors to hesitate, as the pharmaceutical and biotechnology sectors rely on predictable and reliable regulatory processes to attract funding [4]. - A report indicated that the FDA has approved only 32 drugs this year, with review speeds lagging behind previous years, which poses significant challenges for companies seeking FDA approval [4][5]. - The FDA may face a dilemma of either slowing down the approval process significantly or compromising the rigor of its reviews, which could endanger public health [5].