“As an industry, we sometimes get caught up in regulatory distinctions that most consumers really don’t care about. When they walk up the pharmacy aisle, they see an increasingly wide assortment of FDA-regulated traditional O-T-Cs, homeopathic remedies, nutritional supplements and devices. Consumers are embracing these self-care options that they can access at retail without the intervention of a doctor or pharmacist. They are seeking to prevent sickness, to self-treat minor conditions and to avoid unnecessary doctor appointments. In light of this evolving and more empowered consumer, we decided that CHPA should take a more holistic approach to self-care. In reality, most of our member companies were already there.” One thing that will not change is the association’s pivotal role in representing the industry in Washington, D.C., and state capitals. The long-sought objective of updating the regulatory framework governing the majority of O-T-Cs was attained at the end of March, when Congress enacted the third in a series of measures designed to address the COVID-19 crisis. About 50 pages of the massive law are devoted to reform of the O-T-C Monograph system, as well as the reinstatement of the right to pay for O-T-C medicines and, for the first time, menstrual care items, with Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs).
“The regulatory system for over-the-counter drugs had rusted shut,” Melville notes. “It was not efficient. It did not accommodate innovation.” The new law is expected to foster innovation in self-care by creating a streamlined process that the Food and Drug Administration can use to update monographs as science and technology evolve, enabling O-T-C suppliers to submit requests to the agency to alter monographs to pave the way for new dosage forms, new claims or new combinations, or to add an existing ingredient to a monograph. Changes like these that win FDA approval can qualify for 18 months of exclusivity.
“These provisions of the CARES Act will have a significant effect on health care in America,” Melville says. “We are absolutely going to see more innovation in the O-T-C aisle as a result of monograph reform — new indications for existing products, new combinations of ingredients, new dosage forms and new products that have been on the market outside the U.S. — in addition to Rx-to-O-T-C switches which are regulated under a different framework.” CHPA is realigning operations in order to meet the needs of members involved in dietary supplements and medical devices as well as O-T-C medications. “One thing we’ve done internally is make sure that we are resourced in all of our functions to have dedicated staff and resources focused to each of these three categories,” explains Melville.
In addition, the association has established three councils made up of executives from member companies and CHPA staffers to establish category priorities and provide strategic advice to the board of directors. “We realized that the association needed some formal structure that would allow business leaders in each category to meet with each other to talk about issues and to help understand the environment for O-T-C drugs, for dietary supplements and for consumer medical devices, respectively” Melville says. “The councils are designed to identify trends, help the association prioritize issues and initiatives, and essentially serve as CHPA’s think tank for each of our three self-care categories.”
The recent development bodes well both for the association and for the industry it represents. “I certainly anticipate more products in the self-care aisle coming down the road,” Melville notes. “Consumers have spoken. They want to practice responsible self-care. They want safe and effective self-care options at their fingertips. They want convenience. They want value. Our industry is ready to respond, and I am optimistic that the regulatory system will provide consumers new and improved O-T-C options given the authorities that FDA has been provided under the new monograph reform law.”
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