Joint letter to Congressional leadership urging passage of CREATES Act

This letter was originally organized and sent by the Campaign for Sustainable Rx Pricing to Congressional leadership. To see the PDF with the full list of co-signers, please click here.

Dear Majority Leader McConnell, Leader Schumer, Speaker Ryan, and Leader Pelosi:

The undersigned organizations write to voice our strong support for the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) and encourage Congress to pass this important, bipartisan legislation as soon as possible.

President Trump remarked in his State of the Union address that the “injustice of high drug prices [is] one of our top priorities.” It is also a top priority for voters across the country, and Congress has a golden opportunity to make a real impact on prescription drug prices by passing the CREATES Act.

Each of our organizations is committed to ensuring that Americans have access to the life-enhancing and life-saving medications that they need at an affordable price. It is undisputed that the key driver of affordability in prescription drugs is competition from generics once the market exclusivity has expired on a brand-name medication. Unfortunately, manufacturers of brand name drugs often go to great lengths to stave off competition from generics in order to keep prices high.

In particular, certain companies abuse the Food and Drug Administration’s (FDA) regulatory rules that allows them to use a tool designed to protect patient safety as a pretext to deny generic manufacturers the ability to purchase the samples they need to bring more affordable FDA-approved drugs to market. These actions contradict Congressional intent. Through this anticompetitive abuse, brand companies extend their monopoly pricing power, costing patients and the healthcare system an additional $5.4 billion annually.

The CREATES Act is a narrowly targeted, bipartisan, pro-competition, and market-based solution to these abuses that cost patients, job-creators, and taxpayers billions of dollars each year. The CREATES Act is a step towards restoring the balance that Congress attempted to strike in Hatch-Waxman, between providing incentive for innovation through exclusivity while providing for affordability through generic competition.

We thank the bipartisan, bicameral sponsors of this important legislation for the work that they have done to, in the words of FDA Commissioner Scott Gottlieb, “end the shenanigans” by certain brand companies, and we strongly encourage Congress to pass the CREATES Act without delay.