WASHINGTON During her opening address to Consumer Healthcare Products Association members here, Linda Suydam, president of the CHPA, noted that two Food and Drug Administration meetings held last year have forever changed the over-the-counter regulatory landscape.
The two meetings Syudam referenced—an FDA advisory panel on the efficacy of children’s cough-cold medicine and a separate panel on the efficacy of phenylephrine—called into question the long-standing efficacy of monographed products. “What was learned from both of these meetings is that the regulatory landscape is changing,” she said. “We must move forward on the science supporting our product.”
To this end, CHPA is already committed to conducting pharmacokinetic and efficacy studies in pediatric populations for monographed OTC medicines.
Another point of concern identified by Suydam was the issue of dextromethorphan abuse. She commended the industry for pulling together on this issue, and through CHPA effectively raised awareness and education behind DXM abuse. “The level of cooperation among members this past year has been exceptional.”
Looking forward, the industry prognosis is positive, however not without its challenges. For example, “FDA’s chronic underfunding will take a long time to rectify,” Suydam said, regardless of whether a Democrat or a Republican wins the presidential election next year.