FDA Policy/General

Committee to Protect Health Care: Don’t Approve Overton

The Committee to Protect Health Care has sent a letter signed by over 2,500 physicians to members of the Senate, urging them to reject the Trump administration’s nomination of Heidi Overton to be FDA commissioner. “Dr. Overton’s dangerous record on vaccines and extremist anti-abortion advocacy are deeply troubling, and render her unfit to lead such a critical public health institution,” the letter says.

Citing sources for their concerns, the physicians say that Overton opposes school vaccine requirements and played a key role in the administration’s recent orders to modify childhood vaccine policies, “which is exacerbating chaos and confusion for parents who are simply trying to protect their children from preventable disease.”

The letter says the physicians are equally concerned that Overton has been an outspoken opponent of abortion and has advocated for greater restrictions on mifepristone, used in medication abortions. It notes that she wrote a 2023 policy paper opposing medication abortion access via telehealth. “That is especially concerning as FDA is currently conducting a new review of mifepristone, a study which could be used by the Trump administration to ban its distribution,” it says “FDA’s decisions about this medication should be made according to science and facts, not according to an individual’s ideological position on abortion. Dr. Overton’s extensive and extremist anti-abortion advocacy is in diametric opposition with that principle.”

The doctors conclude that the FDA commissioner “must be prepared to follow the evidence wherever it leads, even when that evidence conflicts with political preferences. They must be willing to listen to career scientists, public health experts, physicians, providers, patients, and researchers and to make independent regulatory

decisions. At a time when public confidence in vaccines is already under strain, and foodborne illnesses have been sickening tens of thousands of Americans, the FDA cannot afford to have its scientific independence called into question. FDA requires a commissioner who will put evidence and patient safety ahead of ideology and political pressure. Dr. Overton’s blatant attacks on abortion and support for President Trump’s dangerous vaccine orders disqualify her from the position.”

Patient Advocate Urges Safety Metrics in PDUFA, GDUFA Deals

Patient-safety advocate Suzanne B. Robotti is calling for stronger postmarket safety and drug-quality accountability measures to be added to the upcoming reauthorization of the brand and generic drug user fee programs. Writing in an 10/1 MedShadow opinion piece, Robotti said she urged FDA during September public meetings

Talk to FDA Early About Foreign Clinical Data: Analysis

While FDA is stepping up scrutiny of foreign clinical trials, particularly studies conducted outside an IND (see earlier story), drug sponsors should discuss their plans to rely on foreign data with FDA early in development, including at pre-IND meetings, and put greater emphasis on site selection, monitoring, investigator training

CDRH Proposed Guidances for FY 2027

CDRH has released its list of proposed guidances for FY 2027. The document separates the proposed guidances into three lists: * A List — priority guidance documents the Center intends to publish in FY 2027; * B List — guidance documents CDRH intends to publish as resources permit during FY 2027; and * Under Construction

14 Observations on Houston Rx FDA-483

FDA has released the Form FDA-483 issued following an 8/20-8/28 inspection at Houston Rx, a Houston, TX, producer of sterile drugs. The 14 inspection observations were: * personnel performed aseptic manipulations with exposed hair or skin; * a pattern of frequent or acute pressure reversals was observed from

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Patient Advocate Urges Safety Metrics in PDUFA, GDUFA Deals

Talk to FDA Early About Foreign Clinical Data: Analysis

CDRH Proposed Guidances for FY 2027

14 Observations on Houston Rx FDA-483