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
FDA Policy/General
FDA is announcing a 10/9 Vaccines and Related Biological Products Advisory Committee meeting that will discuss and make recommendations on the strain selection for influenza virus vaccines for the 2026 Southern Hemisphere influenza season. Additionally, the panel will discuss and make recommendations on advancing CBER’s allergen standardization program.
FDA Policy/General
The House Energy and Commerce Committee has unanimously approved legislation to reauthorize FDA’s Rare Pediatric Disease Priority Review Voucher program, a move hailed by patient advocates and drug developers as a crucial step in sustaining incentives for treatments targeting rare childhood illnesses. The measure, called the Creating Hope Reauthorization
Drugs
A direct-to-consumer TV ad for CSL Behring’s Hizentra (immune globulin subcutaneous (human)) overstates the drug’s effectiveness and minimizes safety information, thus misbranding it, according to a CBER Warning Letter. The letter says the Hizentra labeling describes it as a 20% liquid subcutaneous immune globulin indicated to
FDA Policy/General
FDA has released 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major push (see earlier story) to crack down on misleading direct-to-consumer drug advertising. For example, a letter to AstraZeneca addresses a specific DTC
FDA Policy/General
FDA is moving to rein in direct-to-consumer (DTC) pharmaceutical advertising after decades of weak oversight allowed misleading promotions to flood the U.S. market, according to a new JAMA article by FDA commissioner Martin Makary. He called drug advertising a “public health crisis” in need of urgent intervention.
FDA Policy/General
FDA under President Donald Trump is pushing forward with plans discussed during the Biden Administration under commissioner Robert Califf to scale back its long-standing practice of convening independent advisory committees to review new drug applications — a shift that critics warn could reduce transparency and weaken public trust in the
FDA Policy/General
Capsida Biotherapeutics has halted enrollment in its SYNRGY clinical trial that is evaluating CAP-002, an investigational intravenous (IV)-administered gene therapy for treating STXBP1 developmental and epileptic encephalopathy, due to a patient death in the trial. The company says CAP-002 is the first IV-delivered, adeno-associated virus
FDA Policy/General
FDA has ordered pharmaceutical companies to remove any “noncompliant ads” and bring all promotional communications into compliance with the Federal Food, Drug, and Cosmetic Act. Thousands of letters have now been sent to companies warning that the agency is moving to “take aggressive action” against violative ads, citing longstanding concerns
FDA Policy/General
Former FDA Digital Health Center of Excellence acting director Sonja Fulmer has left the agency to accept a position at Mayo Clinic as senior director of health policy. Fulmer had been at the agency for 11 years, and assumed her role as acting director in April after director Troy Tazbaz,
Biologics
The latest Make America Healthy Again (MAHA) Commission report, “Make Our Children Healthy Again: Assessment,” says FDA has a role to play in working with the National Institutes of Health to “build systems for real-world safety monitoring of pediatric drugs and create programs to independently replicate findings from industry-
FDA Policy/General
Former FDA commissioner Scott Gottlieb is warning that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challenge the scientific basis of the nation’s pediatric vaccine program. Speaking on CNBC 9/8, Gottlieb said he believes Kennedy intends to link aluminum
FDA Policy/General
Health and Human Services secretary Robert F. Kennedy Jr. was grilled over his controversial policies and actions during a contentious three-hour Senate Finance Committee hearing 9/4 marked (XXX DELETE, INSERT XXX)by sharp bipartisan criticism and heated exchanges. Senators from both parties questioned Kennedy's recent public
FDA Policy/General
Calls for HHS secretary Robert F. Kennedy Jr. to leave office are intensifying. Over a thousand current and former staff at FDA, CDC, and NIH have joined a new open letter to Kennedy and Congress, calling for Kennedy to resign or be fired. "We warn the President, Congress, and