Speakers from the EMA and European Commission, as well as Pfizer and HRA Pharma, debated at the AESGP's Regulatory Conference the ongoing digital transformation of the European consumer healthcare market, the latest developments in the implementation of the new medical devices regulations, and the best ways to encourage Rx-to-OTC switching across the EU.

Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.

Poland's ministry of health is calling for codeine, dextromethorphan and pseudoephedrine to be reverse-switched from OTC to prescription status in response to abuse of the drugs by adolescents. At the same time, an academic paper argues Ireland should restrict codeine to prescription-only sale to combat an addiction epidemic "verging on eruption."

European self-medication association AESGP is one of several European pharmaceutical industry bodies to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

One active ingredient in unapproved drugs sold by two e-commerce operations, identified by FDA as Rabold and AidAccess.org, is mifepristone, also known as RU-486 in the only drug with the ingredient approved for an indication of medical termination of early pregnancy, Danco Laboratories' Mifeprex. Firms' websites offer sales of products without requiring customers to submit prescriptions.

France's Prime Minister Edouard Philippe intervenes in the debate over whether to liberalize the country's still very traditional pharmacy market. 

Zentiva has signed its first acquisition after it was carved out from Sanofi last year to become an independent company, entering into a shared purchase agreement with Siyiara to acquire Romania-based food supplement and OTC medicines producer Solacium.

Assessing how closely GSK's brands such as Panadol compete with Pfizer brands like Robitussin is the aim of an investigation launched by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. 

Trimb has gained the exclusive rights from Teva to market across Scandinavia a portfolio of "well-known" consumer health brands, covering skin-care, oral-care, and digestive health, as well as dietary supplements. 

While Rx drug pricing is under attack by Congress, White House and consumer and public health advocacy groups, OTC drugs' value isn't gaining a higher profile. "Our health care system undervalues the contribution of our industry's products," says CHPA chief Scott Melville. Trade group conducts “Value of OTC Medicines" study for reasons including raising the profile of consumer health products in the US health care system.

Zur Rose adds French online retail platform Doctipharma as two board members resign over “differences of opinion” with regards to the firm's growth strategy.

Cosmetics Europe expects its in vitro method for SPF determination to be a published ISO standard within two to three years. The European Commission is behind in vitro sunscreen testing, and the method could significantly reduce costs and technical challenges while providing in vivo-equivalent results, the trade group says.

Notwithstanding a particularly difficult 2018, Bayer Consumer Health still has "one of the best brand portfolios," and can continue to compete with the market leaders, says CEO Werner Baumann. Consumer Health struggled particularly in the US and Europe in the 12 months, with the majority of its leading brands recording poor performances.

RB's Health business failed to keep pace with market growth in 2018, with the firm admitting its mindset in Europe "needs to change." The UK-based consumer-goods giant spent the 12 months working on its RB 2.0 restructuring program, which will give it the option to separate into two independent companies focusing on Health and Hygiene by 2020.

France's self-medication market had a difficult 2018, due to a weak flu season and changing dynamics in the sector, according to industry association Afipa. Despite this it was a good year for Sanofi, which overtook Boiron as the number-one OTC firm in the market, while its Doliprane analgesic became France's best-selling brand.

As "market leader" in OTC nicotine replacement treatments, Perrigo should "be the one that's doing a lot of innovation," says CEO Murray Kessler. He discussed Perrigo's problems and potential sales drivers as it reported 2018 net sales of $4.7bn, down 4% , and Q4 net sales of $1.2bn, down 7%. Global consumer health product sales for year were flat at $3.9bn and Q4 sales were down 4% at $973m.

Former Biotene owner Laclede ordered by federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.

JP Morgan analysts had questions and J&J CEO Alex Gorsky and CFO Joseph Wolk had answers about liability suits alleging that use of the Johnson's brand talcum powder has caused mesothelioma or ovarian cancer. On the Johnson's brand outlook following its relaunch as a natural product line, Gorsky says sales were a key driver in the firm's consumer health sales in the 2018 third quarter. China, meanwhile, is a model for growing sales online, he says.

GSK, Pfizer, HRA Pharma and Mentholatum all enjoyed a particularly fruitful evening at the OTC Marketing Awards 2019. J&J, P&G and RB were also among the winners at a celebration of the best and brightest in the UK consumer health market. 

Sanofi has overcome production challenges to bring its OTC migraine and tension headache treatment Syndol back to the UK market after more than five years away.

Trademarks registered and published for opposition with UDPTO in Class 3 – cosmetics and cleaning Preps, and Class 5 –pharmaceuticals. Marks for vitamin, mineral and supplement products also are registered or published for opposition in both Class 3 and Class 5.

GSK, Pfizer, HRA Pharma and Mentholatum all enjoyed a particularly fruitful evening at the OTC Marketing Awards 2019. J&J, P&G and RB were also among the winners at a celebration of the best and brightest in the UK consumer health market. 

National Advertising Division recommends Sanofi add "nearly" to claim that Xyzal Allergy 24HR is "as effective at half the size" of J&J's Zyrtec in a TV ad because 3D modeling comparing the products showed Xyzal tablet has 73-mm volume and a Zyrtec tablet's is 145.2 mm. Sanofi's evidence also supported referring to Xyzal's size would not mislead consumers to expect its drug has half the pharmaceutical dosage of Zyrtec.

Olay skin care ad during Super Bowl with actress Sarah Michelle Geller could usher in era of for women’s products during the event. Marketing experts say as advertisers look to identify more with women’s issues and take on political or social bents, they should tie brands with messaging that is straightforward.

Two UK advertising complaint verdicts delivered by the MHRA, Reckitt Benckiser's Nurofen Express (upheld) and Perrigo's Solpadeine Max (not upheld).

The UK's Advertising Standards Authority has cleared Reckitt Benckiser of misleading British consumers with two advertisements for its Nurofen brand of analgesics.

UK Advertising Standards Authority says despite P&G’s modification of a claim in TV ads for Oral B Gum and Enamel Repair toothpaste, visuals in the ad combined with claims suggest the product can repair enamel.