FDA Faces Criticism Amid Declining Drug Approvals in 2025

The Food and Drug Administration (FDA) is facing significant scrutiny as concerns mount over its increasing reluctance to approve new medications. In a recent commentary, Dr. Marty Makary, Commissioner of the FDA, highlighted the agency’s accomplishments for the year 2025, emphasizing reduced decision times and accelerated drug approvals. However, critics argue that the agency’s heightened risk aversion is stifling innovation and leaving patients with fewer treatment options.

Despite boasting a consistent average of 46 new therapeutic agents approved in 2025, the FDA’s overall approval rates are not keeping pace with the growing number of drugs entering clinical trials. A report from Nature indicates that while the FDA has maintained a steady approval count, the pipeline of drugs awaiting evaluation has expanded significantly. According to data from RxDataLab, the number of active “Investigational New Drugs” has surged from approximately 11,000 in the five years preceding the COVID-19 pandemic to over 14,000 in recent years. This increase highlights the disconnect between the growing demand for innovative treatments and the FDA’s current approval capabilities.

Concerns Over Risk Aversion

The FDA’s recent decisions regarding several high-profile medications illustrate this trend of risk aversion. For instance, the agency has repeatedly denied approval for an ophthalmic version of Avastin, which is already permitted for other uses, to treat wet age-related macular degeneration. The FDA contends that there is insufficient evidence for its effectiveness, a stance not shared by regulatory bodies in Europe.

Similarly, the FDA’s rejection of a higher dose formulation of Spinraza, used for treating spinal muscular atrophy, was attributed to a lack of technical information in the drug’s application paperwork. Reports indicate that the required data is readily available, yet the agency prioritized documentation over the urgent need for effective treatment options. Patients in Japan have access to this higher dose regimen, raising questions about the FDA’s standards.

The agency also faced criticism for its handling of Ebvallo, a medication for a rare and often fatal blood cancer. The FDA has been hesitant to approve clinical trials for this drug, not due to safety concerns, but due to issues at third-party manufacturing sites. In contrast, patients in Europe have had access to this life-saving treatment since 2022.

Missed Opportunities for Patients

The FDA ended 2025 with yet another controversial rejection, this time for relacorilant, a drug designed to treat Cushing’s syndrome, a rare hormonal disorder. Despite evidence from clinical trials indicating significant benefits, including improvements in blood pressure and glucose levels, the FDA insisted on additional efficacy data before granting approval. This decision denies patients the ability to make informed choices regarding their treatment options.

Critics argue that the FDA’s current approach hampers progress in medical innovation and access to necessary therapies. The agency has the potential to save lives by expediting the approval process while maintaining safety standards. As frustrations grow among patients and healthcare providers, the demand for a more responsive regulatory environment becomes increasingly urgent.

The ongoing debate surrounding the FDA’s approval processes underscores the critical balance between ensuring safety and fostering innovation. As the agency navigates these complex challenges, the implications for patients seeking effective treatments remain a pressing concern for many Americans.