This week at FDA: Kennedy defends HHS cuts, drug pricing EO, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, HHS Secretary Robert F. Kennedy Jr. defended the HHS cuts in a contentious hearing and President Doanld Trump issued an executive order on drug pricing.

In back-to-back hearings before the House Appropriations and the Senate Health, Education, Labor and Pensions committees, Kennedy defended the broad changes he has enacted across HHS, including the mass layoffs of thousands of federal workers. Rep. Rosa DeLauro (D-CT), the top Democrat on the House Appropriations Committee accused Kennedy of overextending his authority by impounding funds appropriated by Congress.

The hearing is reportedly the first time in more than 20 years that an HHS Secretary had testified to a Senate committee about the agency’s budget, and touched on topics including vaccines, autism, and drug pricing, as well as proposed spending cuts under the Trump Administration’s budged request, according to Medtech Insight.

According to The Guardian, Kennedy also said he has ordered FDA to review regulations pertaining to the abortion drug mifepristone and said that such a review is needed based on data from a recent non-peer reviewed analysis by the Ethics and Public Policy Center that some experts say is flawed and exaggerates safety concerns about the drug.

This week, Trump signed an executive order aimed at cutting prescription drug prices by calling on federal agencies to institute “most favored nation” (MFN) pricing policies, bringing back a previously scrapped policy from the first Trump administration. The order expresses concern that Americans are subsidizing lower-priced drugs and biologics in other developed countries while paying higher prices in the US. To address this situation, President Trump ordered a series of measures including obtaining voluntary price concessions from manufacturers. If drug manufacturers do not voluntarily provide American consumers with the MFN lowest price, the executive order outlines additional actions, including importation and mandatory MFN pricing.

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement critical of the order and directed blame for high US drug prices to pharmacy benefit managers and foreign countries “not paying their fair share.”

“Importing foreign prices from socialist countries would be a bad deal for American patients and workers. It would mean less treatments and cures and would jeopardize the hundreds of billions our member companies are planning to invest in America – threatening jobs, hurting our economy and making us more reliant on China for innovative medicines,” said PhRMA President and CEO Stephen Ubl.

On Wednesday, the Government Accountability Office issued a report outlining 35 priority recommendations for HHS, which address leadership of public health emergencies and FDA oversight. The report stressed the need for effective FDA oversight and recommended that FDA beef up its foreign inspections program to ensure that imported drugs are safe.

Drugs & biologics

FDA’s Oncology Center of Excellence announced the launch of its Project Interface outreach and engagement initiative, which aims to connect patients diagnosed with cancer to patient advocacy organizations and oncology experts. The project coordinates listening sessions and meetings for patient advocates and stakeholders to engage with OCE staff about cancer-related topics.

FDA announced it is taking action to remove concentrated ingestible fluoride prescription drug products for children from the market. These products, which are swallowed and ingested by infants and toddlers, have not been approved by the FDA. The agency says these products alter the gut microbiome in childhood while other studies have suggested an association between fluoride and thyroid disorders, weight gain, and possibly decreased IQ. The American Dental Association (ADA) objected to the proposal, saying there is “limited research” linking microbiome composition and fluoride and arguing that ingestible fluoride products are necessary tools to fight tooth decay.

FDA issued a warning letter to investigator Nana Barseghian for failing to adhere to the inclusion and exclusion criteria for selecting patients in clinical trials. The investigational plan called for excluding subjects with any risk factors such as obesity from participating, yet the investigator enrolled participants that had a BMI higher than the stated thresholds.

FDA sent an untitled letter to Mayne Pharma after reviewing a speaker deck for a professional presentation for its oral contraceptive drug Nextstellis (drospirenone and estetrol tablets). The company made “false or misleading claims” about the risks of the drug, FDA wrote in the letter. “The speaker deck is particularly concerning given that Nextstellis is associated with a number of serious and potentially life-threatening risks, including a boxed warning regarding increased risk of serious cardiovascular events from cigarette smoking and CHC use.”

The Consumer Healthcare Products Association (CHPA) announced the appointment of Scott Furness as senior VP of regulatory and scientific affairs. Furness spent over 25 years in various leadership roles at FDA, most recently as director of the division of product quality assessment at the Center for Drug Evaluation and Research’s (CDER) and Office of Pharmaceutical Quality (OPQ).

The Duke-Margolis Institute for Health Policy and FDA will host a hybrid public workshop on generic drug repurposing that will explore the potential role of the regulator and policy solutions.

Devices:

Appearing before the Senate Finance Committee, AdvaMed CEO Scott Whitaker warned that tariffs threaten the US medtech industry’s and called for greater flexibility to protect the medical device supply chain. According to Medtech Dive, industry supports the 90-day pause on most country-specific duties and the recent agreement with China to temporarily reduce tariffs.

Teal Health announced FDA approval of an at-home self-collection device for cervical cancer, and a Teal Wand collections kit and an end-to-end telehealth service providing visual access to Teal medical providers who price the kit, review the results from the lab, and support women through their home screening.

FDA announced the approval of the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio can be used for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients showing signs and symptoms of the disease.

MedTech Dive reports that the Securities and Exchange Commission has wrapped up its investigation into Illumina’s acquisition of liquid biopsy firm Grail and recommended against taking any enforcement action.

Food & nutrition

FDA announced it is launching a systematic review of food chemicals on the market that will feature a “modernized, evidence-based prioritization scheme for reviewing existing chemicals.” The agency said it will also update its list of chemicals under review to include BHT, BHA, and ADA.

FDA and HHS announced the next steps in Operation Stork Speed to review the nutrient content of infant formula. The agency said it will conduct a comprehensive review of infant formula ingredients and has issued a request for information to gather input on the process.

This week at FDA: Kennedy defends HHS cuts, drug pricing EO, and more

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