CBO Offers Positive Score for Senate Bill to Reform OTC Drug Regulations

Regulatory NewsRegulatory News | 12 December 2018 |  By 

The Congressional Budget Office (CBO) this week said that a Senate bill that would create a new user fee program for over-the-counter (OTC) drugs would not increase the budget deficit.

“Over the 2019-2023 period, spending would lag collections by $10 million,” CBO said.

Elizabeth Jungman, Pew’s director of public health programs, told Focus: “The CBO score seems like a sign that things are moving in the right direction. Hundreds of millions of Americans use OTC products every year, and there is support for reform across parties in both the House and Senate. Passing this legislation would protect public health and allow for innovation, and give FDA the funding it needs to effectively oversee OTC drugs.”

The Senate bill would let FDA collect and spend fees paid for by industry through 2023 to cover the costs of expediting FDA’s regulatory activities relating to the OTC products. The bill would also grant two years of exclusivity for certain qualifying OTC drugs.

The House, meanwhile, passed its version of the bill last July and would also collect fees but would only grant 18 months of exclusivity.

Marc Schloss, VP of federal government affairs, at the Consumer Healthcare Products Association, told Focus:
“The current OTC regulatory system is outdated, cumbersome, and does not inspire innovation. Under Monograph reform, we would see increased efficiency and transparency, while providing the agency with more efficient work processes and the resources it needs to continue protecting public health... We are hopeful that there is enough bipartisan support and momentum behind Monograph reform to see it over the finish line in the near future.”

As far as where the Senate bill is currently, according to Politico, Sen. Richard Burr (R-NC) put a hold on the Senate bill because of concerns about the user fees. A spokesman for Burr did not respond to a request for comment.


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