FDA Policy/General
Health and Human Services secretary Robert F. Kennedy Jr. has privately discussed plans to scale back the operational role of FDA commissioner Marty Makary, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure — a move that administration officials
FDA Policy/General
FDA commissioner Marty Makary and CBER director Vinay Prasad offered an unusually candid preview of upcoming agency reforms during an FDA Direct podcast focused on the appointment of longtime oncology regulator Rick Pazdur as CDER’s new director (see earlier story). The two officials described Pazdur — formerly head of the
FDA Policy/General
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in the agency. The article notes that top Trump-era health officials entered office arguing that the FDA lacked transparency, was overly influenced by industry, and failed to follow
FDA Policy/General
University of Chicago researchers say that while the federal government has proposed expanding direct-to-consumer ad oversight to include influencer partnerships and sponsored content, “effective oversight will be challenging because promotion is driven by thousands of individual creators rather than a few dozen companies.” Writing in a JAMA Research
FDA Policy/General
FDA has introduced a new regulatory framework — the “plausible mechanism pathway” — designed to speed approval of highly personalized therapies for rare genetic diseases, according to an 11/12 article published in The New England Journal of Medicine by CBER director Vinay Prasad and commissioner Marty Makary. The accelerated pathway aims
FDA Policy/General
An 11/19 MAHA Summit in Washington will bring together leaders and influencers of the Make America Health Again movement, according to an event schedule obtained by Politico. An online post says the gathering will hear from vice president JD Vance and HHS secretary Robert F. Kennedy, Jr. The summit
FDA Policy/General
FDA Matters president Steven Grossman says strong morale will be built at FDA based on a foundation of trust. After reviewing all that has battered the agency in the first year of President Trump’s second term, Grossman raises the question of whether FDA staff morale is primed to rebound
FDA Policy/General
Despite recent departures among its senior ranks and turmoil caused by the ongoing government shutdown, FDA remains robust, according to commissioner Marty Makary, who spoke at the Milken Institute’s 2025 Future of Health Summit 11/6. Makary emphasized a shift toward a more collaborative culture and outlined ambitious plans
Biologics
The 11/5 Medpage Investigative Roundup highlights key findings in a STAT report (subscription required) about chaos at CBER under the leadership of Center director Vinay Prasad. The report indicates that several CBER employees have filed human resources complaints about the director’s management style and practices. It says employees
FDA Policy/General
President Donald Trump and the White House have “total confidence” in FDA commissioner Marty Makary as he weathers yet another agency crisis with the abrupt departure of new CDER director George Tidmarsh, who was accused of official misconduct by a drug company. A Politico article quotes from an e-mail
FDA Policy/General
Sydnexis says its SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of myopia in children, met both the primary and key secondary endpoints in the Phase 3 STAR trial. A company statement says treatment effects were
FDA Policy/General
Reflecting on the recent FDA turmoil over the resignation of CDER director George Tidmarsh, Axios questions how long industry can “tolerate an underperforming and dysfunctional FDA … before looking to other markets.” Tidmarsh resigned as controversy broke over comments he made on social media that were part of a lawsuit alleging
FDA Policy/General
Sen. Jim Banks (R-IN) is urging FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging oversight in countries that supply the majority of U.S. drug ingredients. In a 10/16 letter to FDA commissioner Marty Makary, Banks warned that “shoddy foreign
FDA Policy/General
With FDA apparently taking a more aggressive stance on direct-to-consumer (DTC) drug ads, two academic researchers call in a Washington Post opinion column for the agency to create a “Drug Facts” box to go with ads. The column says that DTC ads “almost always fail to communicate what
FDA Policy/General
Fifty-one Republican senators are urging FDA to restrict access to abortion pills following the agency’s recent approval of a new generic version of mifepristone. The letter called on the agency to suspend approval of generic mifepristone until a planned safety review (see earlier story) is completed. It also
FDA Policy/General
Americans’ ratings of FDA and five other major agencies (FEMA, CIA, CDC, EPA, and IRS) “have deteriorated markedly since last year,” according to a new Gallup poll. The pollsters say the six agencies are at or near their lowest point in Gallup’s trend. The report says the only agency
FDA Policy/General
As the government shutdown went into effect 10/1, FDA commissioner Marty Makary told employees that the agency will continue mission-critical activities necessary to protect public health until the budget impasse is resolved. This means the agency is directed to respond to foodborne illness outbreaks, manage high-risk food
FDA Policy/General
The Washington Legal Foundation (WLF) says FDA’s recent “crackdown” on direct-to-consumer television advertising runs counter to First Amendment protections for commercial speech that is truthful and non-misleading. A 9/29 letter to the agency cautions that challenges to the agency’s “thousands” of Warning Letters and
FDA Policy/General
FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government and avert an ensuing shutdown, which now seems likely to occur beginning 10/1, according to contingency plans released by HHS. While critical safety functions and some drug and device reviews funded
FDA Policy/General
FDA commissioner Marty Makary has told agency employees that they are protected from planned mass workforce firings if a government shutdown goes into effect 10/1. “I want you to know that would not apply to the FDA,” Makary said in a 30-second video reported by Bloomberg Law that
FDA Policy/General
A survey conducted by the University of Pennsylvania’s Annenberg Public Policy Center (APPC) shows that public confidence in FDA and other U.S. health and science agencies has dropped across the board since the 1/20 inauguration of Donald J. Trump as president. An APPC news release says the
FDA Policy/General
Rep. Frank Pallone Jr. (D-NJ) has sharply criticized Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of undermining vaccine access and endangering public health. Pallone’s comments followed a vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which recently recommended changes that could