Coalition Letter Calling on the Senate Not to End the Current Development of Quality Standards for Biologics

July 23, 2019

Dear Chairman Grassley and Ranking Member Wyden,

As organizations representing American consumers, seniors, taxpayers, and free-market advocates, we are writing to express concerns over Section 207 of S. 1895, the Lower Health Care Costs Act. Many provisions of the bill would expand consumer choice, save taxpayer money, and lower out-of-pocket costs for patients. Section 207 would not.

Our organizations support a robust free market which harnesses competition to drive down costs for American consumers, and which supports innovation by American enterprises. The U.S. free market system, when allowed to function, provides unrivaled consumer choice in a competitive environment, which demands the highest standards for the quality of medicines – standards which are used by more than 100 other countries around the world.

The current U.S. system of public, independent standards for pharmaceuticals reassures patients and physicians about the strength, quality, and purity of the drugs they take and prescribe. These standards, many of which are referred to as monographs, are developed after Food and Drug Administration (FDA) approves an innovator medicine. They do not impede competition between pharmaceutical innovator companies and makers of generic and biosimilar drugs. Instead, they encourage it, by setting public standards through a transparent, scientifically informed process, which are used as a benchmark for development and production by competitors seeking to expand consumer choice and access to life-saving medicines. Europe, where similar standards have been in place for decades, has a robust biosimilars market, with more than 50 biosimilars currently available for sale and use.

Standards for biologics, which have been in place for more than a century, are developed using private sector expertise by committees of current and former industry representatives, regulators, and medical and scientific researchers. This occurs at no cost to the taxpayers, and is administered by a self-funded, nongovernmental non-profit. Repealing the existing standards would undermine taxpayer savings, put additional cost burdens on FDA’s already limited resources, and create a potentially slow, bureaucratic and less transparent process for setting quality standards.

This provision could also jeopardize patient safety and threaten the integrity of the U.S. pharmaceutical supply chain. U.S. Customs and Border Protection utilizes this system of standards to stop counterfeit or substandard medicines from crossing the border, and pharmacists rely on them to fill prescriptions safely and accurately. If implemented, Section 207 could place further demands on the FDA’s enforcement arm, possibly requiring additional taxpayer money with no demonstrable benefit.

The current system is efficient and transparent, and Congress reaffirmed its support by removing similar language out of the 21st Century Cures Act in 2016. We urge your committee to do the same for Section 207 of S. 1895.

 

Respectfully,

 

Steve Pociask

President

American Consumer Institute

 

Wayne Brough

President

Innovation Defense Foundation

 

David Williams

President

Taxpayers Protection Alliance

 

Andrew F. Quinlan

President

Center for Freedom and Prosperity

 

Jonathan Bydlak

President

Coalition to Reduce Spending

 

James L. Martin

Founder/Chairman

60 Plus Association

 

Saulius “Saul” Anuzis

President

60 Plus Association

 

Dr. Joseph Fuhr

Professor Emeritus of Economics

Widener University

 

 

CC:

Senate Majority Leader Mitch McConnell

Senate Minority Leader Chuck Schumer

Members, Senate Finance Committee

Members, Senate HELP Committee

 

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