House E&C Advances Bill With 18 Months Exclusivity as Part of OTC Monograph Reform
The House Energy & Commerce (E&C) Committee on Wednesday advanced a series of bills directed at combating the opioids epidemic, as well as a bill to create a user fee program for over-the-counter (OTC) monographs.The OTC monograph user fee program would allow the US Food and Drug Administration (FDA) to collect fees from industry in exchange for meeting certain performance commitments for completing those reviews.
The bill would add new sections to the Federal Food, Drug, and Cosmetic Act (FDCA) to update what had originally been established by FDA in 1972 to review the safety and efficacy of OTC ingredients in the
At issue in Wednesday’s committee hearing was whether OTC drugmakers should be able to win exclusivity for tweaks to existing OTC products. marketplace.
The House E&C Committee said the bill would enact the following reforms: (1) include by reference, OTC Review Final Monographs and Tentative Final Monographs in statute; (2) create a system for future changes to monographs through an administrative order procedure with the opportunity for development meetings or other consultations, comment on proposed orders, and dispute resolution protections; (3) create a mechanism for faster safety label changes; (4) create a pathway for monograph innovations and (5) include a clause to not prejudice either the new drug approval pathway or nonprescription drugs otherwise marketed under existing enforcement discretion.
The bill would also authorize facility fees totaling $22 million for FY 2019 and incrementally increase said fees to $34 million in FY 2023. The bill includes a five-year authorization.
A hot topic at the hearing Wednesday was the issue of allowing companies to win exclusivity for certain improvements
Rep. Frank Pallone (D-NJ) put forth an amendment to lower that period of exclusivity from 18 months, as the bill initially had it, to 12 months, while Republicans said 18 months was a compromise from an originally discussed 24 months of exclusivity. The Pallone amendment failed to pass, by a vote of 30-24.
Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville applauded the House committee’s passage of the bill.
Under the draft goals letter for the OTC user fee program, drafted last August, FDA committed to hiring more than 100 new full-time employees over the course of the five-year program, beginning with 30 new hires in its first year.
The Senate also introduced its version of the OTC bill in January and on 24 April 2018, the Senate Health, Education, Labor and Pensions (HELP) Committee approved its companion bill, S. 2315, by a 22-1 vote.
Bill Markup
OTC Monograph House Bill