Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues | Wilson Sonsini Goodrich & RosatiJuly 13, 2019
Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs
During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved bipartisan legislation that includes 54 proposals that would aim to reduce health care costs. According to a summary of the bill released by the committee, the Lower Health Care Costs Act of 2019 would reduce costs in three major ways: it would end surprise billing, create more transparency, and increase competition to reduce prescription drug costs.
As part of the goal to reduce prescription drug costs, the bill includes the following provisions that would lower the cost of generic and biosimilar drugs:
- Expedites the drug development process for biosimilar companies through a transparent, modernized, and searchable patent database.
- Improves the Food and Drug Administration’s (FDA) drug patent database by keeping it more up to date—to help generic drug companies speed product development.
- Prevents the abuse of citizens’ petitions that can unnecessarily delay drug approvals.
- Clarifies that the makers of brand biological products, such as insulin, are not gaming the system to delay new, lower cost biosimilars from coming to market; and
- Eliminates a loophole that allows drug companies to get exclusivity—and delay less costly alternatives from coming to market—by merely making slight modifications to an old drug.
Biologics and USP Standards
A provision in the bill that would remove the requirement that biological products meet product quality standards established by the U.S. Pharmacopeia is certain to be subject to contentious discussions if the bill moves forward. FDA officials have pushed for this provision, contending that product-specific monographs for biological products impede technological progress and innovation. A similar provision was included in the 21st Century Cures Act in 2016, but was dropped before the bill’s final passage. Also, the Trump administration included this provision in its FY 2020 budget proposal.
USP officials, along with a coalition of pharmacists and some patient and health care groups, have urged the committee to delete this provision in the bill. These groups maintain that monograph standards are important for ensuring the safety and quality of all drugs and biotech therapies.
Letters and Statements
Cannabis: Congressional Pressure on FDA for Regulations Begins
McConnell Meeting with FDA
On June 27, Senate Majority Leader Mitch McConnell (R-KY) met with Acting FDA Commissioner Dr. Ned Sharpless to remind him of the need for a regulatory framework for cannabidiol (CBD).
In a press statement released subsequent to the meeting, Sen. McConnell lamented that CBD food and dietary supplement products remain in a gray area without clarification from the FDA. “Congress’ intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers…