Leahy Judiciary Committee Statement On The CREATES Act

Thank you, Mr. Chairman, for listing the CREATES Act.  I also want to thank you and Senators Klobuchar, Lee, Feinstein, and many others on this Committee for supporting this legislation.  I am hopeful that we are one step closer today to getting it to the president’s desk, which would result in Americans saving literally billions of dollars on prescription drugs.

The CREATES Act targets a simple yet devastating scheme that some brand name drug companies have used to keep drug prices high:  They simply, without justification, deny competitors the drug samples needed to prove to the FDA that their product is equally safe and effective.  If a potential competitor cannot apply for FDA approval, there can be no competition.  In other cases, a brand name drug company can refuse to agree to a shared safety system needed for drug development.  In either case, the brand can then extend its monopoly long past protections already afforded to it under law, keeping its prices artificially high without fear of competition.

This tactic has been dreadfully effective.  The FDA has no way to compel companies to sell samples.  That is not the FDA’s mission.  Nor should it be.  The FDA’s focus is on drug safety and efficacy.  And traditional antitrust suits take years to resolve and will not result in the consistent, timely sharing of drug samples.   

Yet this behavior is abusive.  It is anticompetitive.  And it is all too common.  The FDA has received more than 100 inquiries from generic product developers who were unable to access samples.  Last month the FDA took the extraordinary step of actually naming drug makers that are improperly denying samples to delay or avoid competition.

The CREATES Act would provide a narrow, efficient, market-based solution to this problem.  It would allow eligible product developers who have been wrongly denied samples to file a lawsuit.  This would allow qualified generic competitors to obtain the samples quickly and bring their product to market sooner.  Our hope and expectation is that no lawsuits would be necessary; that companies would simply stop these abusive gimmicks and sell the samples at market price.

This legislation may make only a small change to the law, but it would have a massive impact.  The Congressional Budget Office says it will save the government $3.8 billion in lower drug costs.  And it will surely save American consumers billions more. 

Every single one of us here has heard from Americans struggling with the cost of prescription drugs.  Many feel compelled to skip doses, or forego promising, possibly life-saving treatment options due to the cost.  Every single one of us here has promised to do something.  Now is the time to follow through.  Achieving affordable drug costs is a massive challenge — larger than one bill —but the CREATES Act is a critical part.

This legislation has support across the ideological spectrum, including 28 bipartisan cosponsors and counting, and nearly 90 outside groups.   Drug affordability is a bipartisan issue.  Today we have a chance to advance a bipartisan solution — a solution that will save Americans billions of dollars in unnecessary drug costs.  I hope every member will join me in supporting this legislation.

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