Policy & Regulation

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Canada’s shortage of children’s analgesic/antipyretic OTCs in 2022 as COVID-19 and seasonal flu virus combined to drive stockpiling by consumers. Some poison control centers and hospitals offered recommendations about modifying adult doses to pediatric use.

OTC antifungal fluconazole will soon only be available with a doctor's prescription in Norway.

Over five years, the cost of the European Commission's proposal could exceed a total €50bn, finds a study by IQVIA commissioned by the AESGP.

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

GSCF research shows that self-care already saves the Asia Pacific region more than $30bn a year in healthcare system costs. To realize higher gains, health literacy, Rx-to-OTC switch and digitalization need to be leveraged, according to the EU-ASEAN Business Council.

APAC health agencies such as WHO and Thailand's FDA are on board with the self-care agenda, and see it as crucial to achieving universal health coverage.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

Consumers in Denmark no longer need a prescription to buy opioid antagonist naloxone as the country looks to tackle the growing issue of overdose.

To improve engagement with patient information, a UK ePI Task Force comprising PAGB, ABPI and BGMA is looking at how electronic patient information leaflets (ePILs) can be introduced in the country.

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

Whether Democrat Harris or Republican Trump is in White House or which party has majority in either chamber of Congress, the FDA’s conundrum will continue around a regulatory pathway for allowing use of ingredients derived from hemp in supplements.

The International Council for Advertising Self-Regulation has launched a "Global Think Tank" to further effective industry self-regulation in the area of advertising, backed by national authorities such as the UK's ASA.

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

Perrigo is among the supporters of a campaign to get a clause of Germany's Medicines Advertising Act removed, which bans the advertising of the OTC morning after pill.

Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.