Banks Questions FDA Nominee on Drug Safety and FDA Oversight

WASHINGTON, D.C. - Yesterday, Senator Jim Banks (R-Ind.) questioned Food and Drug Administration (FDA) commissioner nominee Dr. Heidi Overton during a Senate Health, Education, Labor, and Pensions Committee confirmation hearing. Banks focused his questioning on foreign clinical trials, the danger that abortion drugs pose, and the federal oversight of food ingredients.

Click here or above to watch Sen. Banks' full line of questioning.

Clinical Trials

Sen. Banks opened his line of questions by highlighting that American pharmaceutical and biotech companies are increasingly relying on clinical trials conducted in China, where safety and quality standards are often deficient. He asked Overton how she would strengthen inspections of clinical trials in China and other countries and ensure that Good Clinical Practices are followed.

"China is dominating clinical drug trials, which is concerning because often the standards in those trials are far less safe and effective there than how they are applied in the United States."

Overton agreed that more must be done. She said strengthening and enforcing Good Clinical Practice requirements would be a priority. She also emphasized the need to make it easier to develop and manufacture medicines in the United States.

Mifepristone

Sen. Banks also expressed concern that the FDA has given conflicting answers in the past about its mifepristone safety study, in conjunction with its Risk Evaluation and Mitigation Strategies (REMS) program, and about whether the drug's in-person dispensing requirement will be reinstated. He asked Overton when the safety study would be completed and whether she would commit to accelerating it in the interest of women's safety.

"I'm disappointed that the FDA has removed so many guardrails from this dangerous drug, which carries the strongest black box warning."

Overton said that if confirmed, she would immediately seek a briefing on the study and determine when the review is expected to be completed. She also noted that the FDA owes a court update on the process on October 7 and that separate litigation seeks to eliminate mifepristone's REMS requirements.

Overton added that the safety study must be well-designed, produced in the most durable, scientific way possible and publicly released so Americans can understand its findings. Sen. Banks also pressed Overton about the FDA's responsibility to investigate companies that dispense abortion drugs and mislead women about their risks.

"Is it in the public interest to investigate companies that dispense abortion drugs and mislead women about their risk?"

Overton said FDA-approved drugs are subject to post-market reviews and enforcement, and the FDA has a responsibility to make sure that drug manufacturers comply with federal law, particularly when a drug is subject to REMS requirements.

GRAS Reform

Sen. Banks also questioned Dr. Overton about reforming the FDA's Generally Recognized as Safe (GRAS) food ingredient standard. He praised the mandatory ingredient-notification rule announced by Health and Human Services Secretary Robert F. Kennedy Jr. in August and asked whether the FDA has sufficient resources to evaluate food ingredients.

"Does the FDA have enough resources to do all the ingredient safety evaluations, and how can Congress help you provide better and more resources?"

Overton said that the FDA's Human Foods Program would need additional resources to review the mandatory notifications properly. Sen. Banks asked her to provide Congress with more information about the agency's needs.

Sen. Banks concluded by asking whether states have enough personnel and expertise to independently evaluate food ingredients and establish their own bans and labeling requirements. Overton responded that states' actions can be helpful, but a strong uniform national standard may be needed, especially once a certain threshold of states establish their own requirements.

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