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Latest From Eileen Francis
Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.
OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.
Perrigo's first OTC drug approved in 2018 is extended-relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets, planned for launch under its own store brand, Goodsense, as well as distribution for retailer and private label brands. It already distributes the product for store and private label brands through an agreement with Teva.
OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and has a strong risk/benefit profile, say Pinney Associates consultants. FDA currently is more conservative on risk/benefit decisions and the advisory committee process isn't productive, they say.
MYM subsidiary receives AUD$2.5m investment from Australia to build largest medical cannabis greenhouse in the southern hemisphere; dermatology firm Kamedis introduces products for acne, eczema and dandruff; Life Extension rolls out probiotic formulas under its Florassist line; and more health and wellness news in brief.
Bayer consumer health sales fell 9.1% in Q4 and 2.9% for the year as competitive pressure in the US OTC market, especially from lower-price lines and brands sold on e-commerce sites, cut into sales of its Aleve analgesic and Claritin allergy lines. Heiko Schipper takes over as Bayer's consumer business chief and will lead the division in new initiatives to counter competition with increased marketing support for core brands.