Legislation

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Provision supported by Sen. Mitch McConnell, R-KY, along with House Appropriations Committee chair Andy Harris, R-MD, tightens definition of lawful hemp to exclude any THC derivative from cannabis at more than 0.3% concentration by dry weight and specifically exclude synthetics.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

State and territory attorneys general urge congressional leaders to clarify definition of hemp, which they say “bad actors have exploited due to a perceived loophole” of 0.3% delta-9 THC level stated in 2018 farm bill de-scheduling as controlled substances some ingredients extracted from cannabis.

In addition to Kenvue, complaint names as defendant J&J, which for decades marketed Tylenol oral analgesics before spinning Kenvue out in 2023. State asks court to order firms to pay $10,000 for each violation of state Deceptive Trade Practices-Consumer Protection Act.

The AAM has asked for a federal injunction to block a Connecticut state law on drug pricing that it says represents “an unconstitutional overreach that threatens patient access to affordable medicines.”

As the US biosimilars market enters its second decade, Cencora’s director of biosimilar commercialization Dennis Nelson talks to Generics Bulletin about the progress made so far, as well as fresh regulatory and commercial developments on the horizon.