Senate Committee Advances OTC Monograph Reform Bill

Regulatory NewsRegulatory News | 31 October 2019 |  By 

The Senate Health, Education, Labor and Pensions Committee on Thursday advanced a bill by voice vote that would reform the way over-the-counter (OTC) drugs are brought to market by creating a user fee system like the ones used for prescription drugs and devices.

The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create an 18-month exclusivity period as an incentive for companies to bring innovative OTC products to market.

Beginning in FY 2021, the bill also would assess annual facility fees for OTC manufacturers and contract manufacturers. OTC monograph order request fees would also amount to $500,000 for Tier 1 OTC monograph order requests and $100,000 for Tier 2 order requests. Tier 2 requests are defined in the bill as changes made to the OTC drug label, such as the reordering of existing information or adding new information or modifying the directions of use. Tier 1 requests are defined as other requests that are not considered to be Tier 2.

Sen. Lamar Alexander (R-TN) noted that CDER Director Janet Woodcock pointed to the OTC monograph reforms as one of the crucial pieces of legislation that the agency would like to see done because the current monograph system was implemented in 1972. Former FDA chief of staff Lauren Silvis also said OTC monograph reform is a top priority for the agency.

In June, the Pew Charitable Trusts and other organizations sent a letter to several representatives seeking action on OTC monograph reform.

And action in the House on such reforms has been more successful than in the Senate. The House Energy & Commerce Committee advanced a bill in May 2018 with the same period of exclusivity and that bill was passed by the House in July. Similar legislation from Casey and Isakson was also introduced in April 2018, passed out of the committee and received a positive CBO score, but did not advance to a full Senate vote.

Sen. Richard Burr (R-NC), who asked to have his “no” vote announced to the committee on Thursday, put a hold on the previous Senate bill because of concerns about the user fees. 


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