Legislation

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

Council for Responsible Nutrition contends New Jersey bill, which Assembly Health Committee amended with substantial language to make restrictions more stringent on 23 September, is targeted as inaccurately as restrictions in New York effective in April.

Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.

Joint letter on scheduling for proceedings before a trial CRN’s attorneys and state AG’s office recently submitted in New York federal court includes, among other information, a statement that both the trade group and the state anticipate a settlement could be reached.

Key challenges facing companies working to implement the European Sustainability Reporting Standards have been identified by the European Financial Reporting Advisory Group. Onur Durmus, Partner at sustainability consultancy ERM, shares his thoughts on EFRAG’s findings and offers takeaways for firms that will be subject to the EU’s Corporate Sustainability Reporting Directive.

California Senate Appropriations Committee suspends consideration of bill for current session after it and Judiciary Committee voted to recommend passing the bill earlier in session. Legislative sessions continue in Massachusetts and New Jersey with bills for similar restrictions.

With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.

Just under a third of UK parents who smoke or have smoked in the past believe there isn’t enough support to quit, and nearly a quarter don’t know where to go for support, Kenvue reports, based on recent surveys. In response, the firm launches the “Smokefree Families” initiative to help the 1.8m households in England with children and at least one smoker to become smoke free. 

Marketing authorizations for OTC medicines could be rejected if their environmental risk assessments do not meet new requirements proposed within the EU pharma legislation revision. HBW Insight speaks to regulatory law experts Tine Carmeliet and Eline D'Joos to find out what you need to know about the new rules.

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

The UK's consumer healthcare industry association, PAGB, sets out six priorities for the new UK government, following the landslide victory of the Labour Party in the recent general election. One of these priorities is driving Rx-to-OTC switch - something that the UK public also wants, according to the association's latest Self-Care Census, published to mark International Self-Care Day 2024.

FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.

“Science is pretty evident that there's no connection between supplement use and eating disorders,” says NPA’s Kyle Turk. “CRN continues to raise fundamental concerns about what benefit the bill offers,” says CRN’s Steve Mister.

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

Proposed change is “the first FDA-initiated proposed order that was not statutorily required” by the 2020 legislation authorizing the agency’s overhaul of the program which makes the large majority of nonprescription drugs available in the US.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

The Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium, opens with a rousing call to action from president Jonathan Workman. Looking to the upcoming EU elections, Workman urges industry to push for widening access to OTC medicines through switch, digital and sustainable investment, improved health literacy and regulatory flexibility.

Around 800 pharmacies across Poland have signed up to offer women and girls access to the emergency contraceptive pill without the need to visit their doctor.