Proposed Sunscreen Monograph Hikes Costs, Increases Prices – CHPA, PCPC
Changes in tentative final OTC sunscreen monograph would increase testing costs than FDA estimates and leave consumers with fewer, more expensive products to choose from, say CHPA and PCPC. Firms estimate testing costs will increase roughly 25% to 30% based on proposed changes in protocols.
You may also be interested in...
Industry and the FDA agree that the OTC drug monograph system is direly in need of reform, but innovating with noncompliant dosage forms and indications, without approved new drug applications, is a risk companies need to weigh seriously, says Arnall Golden Gregory partner Alan Minsk. The FDA offers perspective on its OTC monographs for acne and antiperspirant products.
Spaulding Clinical, which the FDA contracted for its sunscreen maximal usage trial published in May, is in discussions with a handful of sunscreen industry players about doing more MUsTs to fulfill data needs identified by the agency. Meanwhile, leading trade groups are interested in talking to the FDA about developing sunscreen study protocols that more accurately reflect real-world consumer usage.
The Personal Care Products Council and Consumer Healthcare Products Association say FDA’s tentative final sunscreen monograph and related communications have given rise to confusion that could lead to reduced sunscreen use and negative public health consequences. The groups go one further: FDA should reissue a tentative final monograph proposing that the 12 chemical UV filters currently in question are GRASE.