OTC monograph reform passes House

The House of Representatives on Tuesday passed H.R. 269 — a package of bills that includes the Over-the-Counter Monograph Safety, Innovation and Reform Act. The legislation is aimed at modernizing the OTC monograph process.

The bill package, which also includes the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, was sponsored by Reps. Anna Eshoo, D-Ca.; Susan Brooks, R-Ind.; Diana DeGette, D-Colo.; Bob Latta, R-Ohio; Brett Guthrie, R-Ky.; Debbie Dingell, D-Mich.; Frank Pallone, D-N.J.; and Greg Walden, R-Ore. The bill’s passage was lauded by the Consumer Healthcare Products Association.

“Today marks the third time the House has passed OTC monograph reform, demonstrating the members’ ongoing commitment to bringing the OTC monograph system into the 21st century,” said CHPA president and CEO Scott Melville. “This legislation has received overwhelmingly bipartisan support because it would make common sense regulatory reforms to increase the efficiency and responsiveness necessary to protect consumer health and spur innovation. We are encouraged that the momentum behind monograph reform is carrying over into the new Congress.”

CHPA said that the current monograph system relies on notice and comment rulemaking, which it said has become increasingly slow and unresponsive as a process. The organization also said that it can take several years to update product labels with new safety information, approve new ingredients or make changes to OTC products. CHPA also argued that the current system doesn’t offer a mechanism for innovation.

The new legislation includes reforms that would speed up the process of decision-making, provide the Food and Drug Administration with funding and staff for OTC-related work, and build an IT infrastructure. It also would improve communication and transparency between regulators and manufacturers by creating a streamlined regulatory path for review of innovations within the OTC monograph system and accommodating changes to ingredients and dosage forms with a submission fee, as well as create a mechanism to encourage investment in the data needed for innovations in self-care for Americans. It also would allow the FDA to quickly address emerging issues due to labeling and safety.

“This legislation is the product of years of collaborative discussion between regulators, lawmakers, public health stakeholders and industry,” Melville said. “It has been a bipartisan effort from the onset, and we are hopeful that the legislation will be quickly considered by the full Senate.”

Other groups that have supported OTC monograph reform include the American Academy of Allergy, Asthma & Immunology, the American Academy of Pediatrics, the American Dental Association, the American Public Health Association, March of Dimes, the National Association of County and City Health Officials, the Society for Maternal-Fetal Medicine, and the Pew Charitable Trusts.