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French Industry Loses Appeal Against Standardized OTC Packaging And No. 42 • 4 November 2019 by “facilitating identification….and im- proving the visibility, readability and un- derstanding of labeling.” The regulator is also looking to curb the practice of umbrella branding for non-prescription drugs which it claims is a source of confusion and misuse among consumers. Its recommendations advise MAHs when seeking product approval not to use a brand name which contains all or part of the name of another existing OTC line or a product which was previously available on the market. In response to ANSM, Afipa described the proposals as “counterproductive and dangerous for patients” and appealed to the court on the grounds that the regula- tor was abusing its power. Rejecting a request by ANSM to have the case thrown out, the court said Afipa French Industry Loses Appeal had grounds for its appeal. Against Standardized OTC INDUSTRY TO BE ‘SIGNIFICANTLY’ IMPACTED While ANSM’s proposals were technically Packaging And Curb On Branding recommendations and devoid of legal ef- TOM GALLEN [email protected] fects, they had the “purpose of significant- ly influencing the behavior of marketing TC drug packaging could before that the outer packaging of non-prescrip- authorization holders, as well as the be- long become uniform and be- tion drugs sold in solid oral form should havior of patients using self-medication,” Oreft of branding in France after display its active ingredient(s) in a font the court judged. As such, the proposals the country’s highest court rejected the larger than that used for all other informa- were “therefore likely to produce signifi- protestations of national self-medication tion, including the brand name or manu- cant effects,” particularly for the OTC in- industry group Afipa. facturer’s name. Marketing authorization dustry, it said. France’s Conseil d’Etat ruled against holders are also advised that brand names On the question of the packaging rec- Afipa, which had sought to have annulled should be displayed in a standardized font ommendations, Afipa argued that ANSM recommendations adopted last year by and all logos, for either the brand or com- was seeking to amend the public health national drug regulator ANSM to stan- pany, should be confined to the reverse or code in such a way that would treat OTC dardize OTC drug packaging and curb side panels of the package. drugs differently from their prescription the practice of umbrella branding. As a counterparts. result, the recommendations continue to MOTIVATED BY PATIENT SAFETY In response, the court said ANSM’s stand. ANSM has stated its goal is to en- ANSM’s rationale for removing branding recommendations did not disregard sure that the recommendations are “prop- and standardizing packaging is to reduce the meaning and scope of Article R. erly implemented by manufacturers.” the risk of medication error and promote 5121-138 of the code which stipulates ANSM’s recommendations stipulate the proper use of non-prescription drugs CONTINUED ON PAGE 4 FOR THE LATEST INSIGHT ON OTC, DIETARY SUPPLEMENTS AND COSMETICS VISIT: HBW.PHARMAINTELLIGENCE.INFORMA.COM HEALTH BEAUTY WELLNESS FDA Adds Homeopathic Enforcement National Toxicology Program: UK Weight Loss Claims Sell Sex Appeal Details, Subtracts Compliance Policy Oxybenzone Shows ‘Equivocal Evidence But Regulator Isn’t Buying, p. 16 Guide, p. 6 Of Carcinogenic Activity,’ p. 10 Global Regulatory and Compliance Insight for Fast Regulatory Approval Successfully navigate the complex world of Pharmaceutical Regulatory and Compliance with access to worldwide intelligence for approved and pipeline drugs. 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Firm reports net sales slumped 13.9% as portfolio optimization strategy focused on shuttering www.pharmaintelligence.informa.com/ 15 P&G Extends Secret Line With Essential Oils, Challenges pink-sheet underperforming stores continues to hamper North ‘Sweat’ With Old Spice American business. Wellness Wellness Market Regulatory News: GMP Crimes, Spiked Product Sentences 16 UK Weight Loss Claims Sell Sex Appeal https://bit.ly/2PzHP5z But Regulator Isn’t Buying Connecticut man faces criminal charges for producing 18 RB Eyes UK VMS Market With Optrex ProVision supplements after agreeing to cease operations due to GMP violations. Two other defendants sentenced on criminal 19 Herbalife CEO, President Changes Effective In March charges following FDA investigations of supplements containing undeclared drugs. HBW-Insight @HBWInsight hbw.pharmaintelligence.informa.com 4 November 2019 | HBW Insight | 3 JN2181 Pink Sheet Advert HBW A4.indd 1 2019/06/05 12:57 HEALTH (OTC DRUGS) CONTINUED FROM PAGE 1 association maintained, which would shared the same or closely related names the information drug packaging must breach Article L. 714-5 of the intellec- were even more likely to be confused by legally display. The regulator was not tual property code. patients than prescription drugs given seeking to amend the code to add to Dismissing this argument, the court they could be obtained without the over- the list of particulars which must ap- said that while ANSM’s recommenda- sight of a doctor. pear, the court judged, but to make tions advocated that logos and brand- By causing confusion, umbrella brand- recommendations relating to the lay- ing should be kept off the front of the ing could also mislead patients regarding out and presentation of those particu- packaging – in favor of the active ingre- a drug’s quality or properties, the court lars, in order to improve readability and dient and strength – they did not pre- noted, which was prohibited under Article consumer understanding. clude their inclusion on other areas of R. 5121-3 of the health code. While ANSM had proposed general the pack and labeling. In recommending MAHs should avoid principles” of “comprehensibility, visibility Addressing Afipa’s concerns about umbrella branding, ANSM was motivated and legibility of statements” – with an em- how ANSM’s packaging proposals by “the risks of medication errors this prac- phasis on the prominent display of the ac- would impact patients, the court said tice was likely to entail”, the court said, and tive ingredient and its strength – the regu- that if packaging was standardized and had therefore not committed any “mani- lator was allowing MAHs to adapt these logos and branding removed patients fest error of judgement.” recommendations according to their own would still be able to identify the drugs Summing up its ruling, the court said constraints, the court observed. they needed by active ingredient. The Afipa was not justified in maintaining that Afipa also claimed that ANSM’s pro- measure would not increase the likeli- ANSM’s recommendations were based on posal to remove branding and logos hood of confusion between medicinal “materially incorrect facts,” or by claiming from the front of drug packs infringed products, it judged. the regulator had overstepped the mark, Article R. 5121-139 of the
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