This Week at FDA: Makary confirmation hearing, HHS to limit notice and comment for rules

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, Health and Human Services Secretary Robert Kennedy moved to limit public comment on some of the department’s actions, bucking decades of precedent. Plus, the Senate HELP Committee has scheduled a hearing to review President Trump’s pick for FDA commissioner next week.

On Friday, HHS posted a Federal Register notice announcing that it will rescind a longstanding policy, known as the Richardson Waiver, that held it to publishing a notice of proposed rulemaking for most rules and regulations, including those exempted from notice requirements under certain circumstances under the Administrative Procedures Act (APA). While the APA allows agencies to bypass notice and comment rulemaking for “matter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” then agencies have “good cause” to do so, the Richardson Waiver held HHS to using the good cause exception sparingly.

Now, HHS says it is doing away with the Richardson Waiver, arguing that the waiver imposed obligations “beyond the maximum procedural requirements specified in the APA.”

“Effective immediately, the Richardson Waiver is rescinded and is no longer the policy of the Department. In accordance with the APA, “matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” are exempt from the notice and comment procedures,” HHS wrote in a policy statement signed by Kennedy. Read more about the policy from STAT News.

The Senate Health, Education, Labor and Pensions Committee has scheduled a hearing for Thursday, 6 March to review the nomination of Johns Hopkins surgeon Martin Makary to serve as FDA commissioner. According to Politico Pro, Makary has been meeting with senators in an effort to ease his path to confirmation.

Politico Pro also reports that two members of the Department of Government Efficiency (DOGE) have been spotted at FDA’s White Oak campus, allegedly seeking information about the agency’s IT contracts, including a contract with billionaire Peter Thiel’s Palantir Technologies.

In other major news this week, FDA canceled an upcoming meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the composition of next year's influenza vaccine. This decision follows the indefinite postponement of a planned meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). Despite, the VRBPAC meeting cancellation and Trump’s moves to leave the World Health Organization (WHO), Reuters reported that FDA and CDC officials participated in a WHO meeting on flu vaccine strain selection for the 2025-2026 flu season.

Endpoints also reported that a group of infectious disease doctors are considering setting up an independent committee to offer “scientifically credible” information about vaccines to the public, following reports that Kennedy plans to revamp ACIP and remove members he feels have are too close to industry.

On Thursday, a federal judge in Washington, DC ordered the Trump Administration to revoke the directives that had led to the firing of thousands of federal workers across the government, ruling that these directives were illegal, according to The Washington Post. The action responds to the firing of thousands of probationary workers at federal agencies, including FDA.

Drugs & biologics

FDA announced it would be discontinuing its REMS program for clozapine, although prescribers are still recommended to monitor the results of absolute neutrophil count (ANC) blood tests in patients taking the drug. The agency acknowledged that while the risk of severe neutropenia associated with clozapine remains, the benefits of the drug outweigh these risks. Removing the Risk Evaluation and Mitigation Strategy (REMS) is anticipated to ease access to the medication.

FDA’s Center for Drug Evaluation and Research (CDER) announced the release of its drug safety priorities report for FY 2024. The report details various programs related to CDER’s drug safety operations, including the FDA Adverse Event Reporting System and the Sentinel System. It also outlines ongoing initiatives aimed at addressing the overdose crisis, efforts to prevent medication shortages, and work to improve the quality of compounded medications within the Sentinel System.

Former CDER Director Patrizia Cavazzoni has returned to Pfizer as the company’s chief medical officer, according to Reuters.

FDA has postponed its upcoming public workshop on optimizing pregnancy registries. The aim of the workshop was to discuss challenges in designing and implementing pregnancy registries and consider new approaches to improve their design. No reason was given for the postponement and a new date for the meeting has not been announced. The annual FDA-NIH Rare Disease Day meeting that would have taken place this week was also postponed indefinitely.

The Office of Generic Drugs issued its monthly and quarterly reports detailing the status of abbreviated new drug application (ANDA) approvals, as well as pending applications awaiting FDA action.

FDA handed Piramal Pharma Limited a Form 483 following an inspection earlier this month. The Navi Mumbai, India-based firm was cited for several issues concerning the inadequate manufacturing of active pharmaceutical ingredients (APIs). Investigators identified problems related to the maintenance of equipment and insufficient investigations into foreign particles discovered in the APIs.

FDA also issued a Form 483 to BPI Labs, an outsourcing facility in Largo, FL, for not including "Office Use Only” on its compounded semaglutide injection products.

Federal health officials from the FDA, OIG, CMS, and CDC have withdrawn as speakers at the Healthcare Information and Management Systems Society meeting in Las Vegas next week, according to STAT News.

In an opinion that appeared in STAT News, BIO CEO John Crowley stated that FDA reform in the rare disease sector needs to be based on strategy rather than on indiscriminate cuts.

A federal judge for the US District Court for the District of Columbia ruled that FDA correctly delayed the approval of Liquidia's lung disease drug Yutrepia (treprostinil) due to United Therapeutics' exclusivity for its blockbuster drug Tyvaso (treprostinil), according to Bloomberg Law.

In other news, the Outsourcing Facilities Association (OFA) filed suit against FDA on Monday for removing Wegovy and Ozempic from the drug shortage list. The group asserts that the shortage is not over, and said FDA’s decision to remove semaglutide from the shortage list is “reckless and arbitrary,” according to Reuters.

The CDC announced that it is in close communication with health authorities in Texas regarding the measles outbreak in West Texas, which has resulted in the death of a child. HHS is providing technical assistance, laboratory support, vaccines, and therapeutic medications as needed to the Texas Department of State Health Services and the New Mexico Department of Health. The agency emphasized that vaccination “remains the best defense” against measles infection, as there is currently no specific antiviral treatment available.

Medtech

On Tuesday, Tandem Diabetes Care announced it received FDA clearance for its next-generation automated insulin delivery (AID) algorithm, for use by adults with type 2 diabetes. The device automatically calculates how much insulin the patient should receive using continuous glucose monitoring data.

FDA has cleared Google’s Pixel Watch 3 to send loss of pulse alerts, The Verge reports. Company officials said the device is can accurately distinguish actual loss-of-pulse events from the removal of the device from a person’s wrist.

FDA approved Medtronic's BrainSense Adaptive deep brain stimulation for patients with Parkinson's disease, the company said. The technology is designed to adjust therapy in real time based on a patient's brain activity, potentially improving symptom control.

This Week at FDA: Makary confirmation hearing, HHS to limit notice and comment for rules

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