OTC Drugs

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.

“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”

Veteran pharma executive leads Vitamin Angels; CEO change to lead unifying Dr. Scholl's brand worldwide; and first CEO change for Prinova in 42 years.

It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.

Key growth driver in consumer health and across Bayer’s sectors, says CEO Bill Anderson, is “dynamic shared ownership program” introduced in January 2024 to "reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes."

HELP Committee members pepper Martin Makary with questions about his investments and potential conflicts of interest as commissioner. Makary’s transparency extends to saying FDA should “use common sense to ask some big questions we've never asked before,” including making more medical products available OTC.

Starboard Value CEO Jeffrey C. Smith and former Bayer consumer health chief Erica Mann among three added to board at Kenvue, which increasing the number of seats temporarily from 11 to 14 until trimming it to 13 at its 2025 annual shareholders meeting on a date yet to be set.