The Food and Drug Administration’s O-T-C monograph system, which hasn’t been updated for over 45 years, is facing massive modernization efforts in the form of pending legislation in both the U.S. House of Representatives and Senate. The current system is “rusted shut,” says Clarion Brands chief executive officer Gary Downing, newly named chairman of the Consumer Healthcare Products Association (CHPA). “It has basically stifled innovation.”
The unwieldiness of the existing monograph system has meant that virtually all of the industry’s growth in recent years has come from products switched from prescription to over-the-counter status, notes CHPA president and chief executive officer Scott Melville. But getting a switch approved is costly and risky and time consuming.
Under the monograph system, which has regulated the vast majority of nonprescription products since the 1970s, O-T-C medicines containing ingredients with a proven history of safe use and efficacy may be marketed without pre-approval as long as they adhere to a monograph — a sort of “recipe book” covering acceptable ingredients, doses, formulations, indications and labeling for an O-T-C medicine. Today, there are over 50 monographs based on therapeutic categories.
“But the recipe book is largely static,” says Melville. The current system’s rigidity has caused any updates to monographs to grind to a halt. Today, when the FDA needs to make updates to an existing monograph based on new science and data, the process can take years to complete. As a result, the current system doesn’t allow for responsiveness to an emerging safety concern or a pathway for the development of innovative products, explains Melville. He points out that branded O-T-C sales grew just 1.8% last year. To improve that growth rate over time, innovation is necessary to meet modern consumers’ needs. CHPA has worked with Congress, the FDA and public health stakeholders over the last couple of years to examine how best to fix the monograph system. The effort is now reaching fruition. Pending bipartisan bills in both the House and Senate have raised hopes that a final monograph reform package will be sent to President Trump this year for his signature.
The key elements of the reform are mechanisms allowing manufacturers to make submissions to update monographs with new ingredients, new claims, new combinations and new delivery systems. That would allow ingredients like acetaminophen and other established ingredients to be considered for new indications and new methods of use, including easier-to-take dosage forms. “We’re very, very excited about that,” says Melville. “That can hopefully bring new products to the market which will help grow this sector and benefit consumers with new choices.”
Moreover, if changes are significant enough, manufacturers will get a period of exclusivity before private label versions can be introduced. The Senate legislation provides for two years of exclusivity, while the House version provides for 18 months. CHPA members could support either time frame, according to Melville, who notes that this would be the first exclusivity provision, under the monograph system, in the industry’s history.
Exclusivity is something even private label manufacturers support. In an op-ed in The Hill, Jeff Needham, president of consumer health care Americas for Perrigo Co., wrote, “If drafted correctly, a modern O-T-C Monograph system can create a surge of innovation that will increase the choices available to consumers, protect the choices they already have and continue to allow transparent price competition.”
Another first for the sector is the new package’s mandate for user (manufacturer) fees to provide FDA with the resources it needs to conduct its O-T-C-related work under the prospective law. “Our members felt that was a reasonable price to pay to change the regulatory structure in a way that will allow more efficiency and provide a pathway for innovation,” Melville says, “because, long term, that’s how they’re going to grow.”
Manufacturers are already looking at areas for R&D, he adds, noting that a new system will take some time to get up and running. The FDA will have to hire a lot more people to manage it, and put together a process for submissions, he says, “but I can tell you that our companies are thinking about areas where they might want to innovate. So it’s exciting.”
Downing emphasizes that the change was borne of a joint effort between manufacturers and the FDA. “It’s great to see good legislation come out as a function of industry and the agency working so closely together,” he comments.