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Legislation

Price To Resolve US Hemp Dilemma Too High In House Appropriators’ FY 2026 FDA Spending Bill

Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

CHPA Survey Shows Consumer Trust In Supplements Strong, Not So Much In Regulation

Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

Proponent For Age-Restricting Diet Supplement Sales Adds ‘Health Inequities’ To Argument

Result of firms marketing weight loss products to Black and Latino girls and to lower-income households is to “worsen health inequities by gender, race, ethnicity and income,” says Harvard researcher Bryn Austin, director of Strategic Training Initiative for the Prevention of Eating Disorders.

Kennedy Defends Spending Cuts During Contentious Senate Hearing On HHS Budget

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.