Regulation

Negative growth in global OTC market sales volume means that “as an industry, we're not doing good enough,” argues Opella’s Asia Pacific, Middle East and Africa (AMEA) head, Carol-Ann Stewart, in this exclusive feature interview.

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

Norway's Medical Products Agency has rejected claims that misuse of OTC ibuprofen is linked to its availability for purchase in outlets other than pharmacies.

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.

Informed Consent Action Network requests warning on acetaminophen-containing OTC monograph drugs in petition submitted by Siri & Glimstad LLP, where partner Aaron Siri has provided legal counsel for HHS Secretary Kennedy. Tylenol marketer Kenvue disputes ICAN’s conclusions and its grasp of FDA regul

Panelists at the BioFuture conference discussed the potential opportunities the government shutdown creates for the FDA to improve flexibility and efficiency.

Regulations likely holding consumer product firms’ attention include the Plastic Pollution Prevention and Packaging Producer Responsibility Act, SB 54, scheduled to become effective by 2027. “Easily the most significant, extended producer responsibility law ever to pass in the world,” says lobbyist

A Senate committee is investigating leadership changes at the US Centers for Disease Control and Prevention. While the primary focus is vaccine policy, the first hearing suggested the probe could raise questions about FDA independence.

Haleon, Colgate-Palmolive and other manufacturers have changed the way they manufacturer toothpaste tubes to be sold in the UK so they can be all be technically recycled.

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.

Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.

Cemag Care may be behind the recent Rx-to-OTC switch of menstrual health treatment tranexamic acid (1000mg) in France.

Recent FDA warning letters hit typical problems in consumer health space such as manufacturing quality control deficiencies, but also note honey offered for eye infections and nasal spray to enhance cognitive function.

“Women's health isn't a niche area," noted Perrigo’s Alison Slingsby at Lynx2Market’s PharmaSynergyOTC event in Rome. Slingsby offers advice from the firm's experience in delivering some of the most innovative women's health Rx-to-OTC switches.

FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.

EMA and MHRA among European regulators reiterating the safety of paracetamol use by pregnant women following news FDA will require OTCs to carry label warning.

Among critics of Trump administration's moves, American Academy of Pediatrics says “White House event on autism was filled with dangerous claims and misleading information.”

“I knew when I was pregnant with my kids the first thing, I knew from just talking to my other friends, before you take anything when you're pregnant, you go to talk to your doctor. I think that's what most pregnant women do,” says regulatory attorney Christine Lawson.

Aska Pharmaceutical has recieved a green light from Japan’s Ministry of Health, Labour and Welfare for the Rx-to-OTC switch of its NorLevo (1.5mg levonorgestrel) emergency contraceptive. Controversially, OTC NorLevo will need to be taken on the spot by purchasers in the presence of a pharmacist.