Statement of Senator Patrick Leahy (D-Vt.) On Introduction of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act

Reforms To Tackle Tactics That Block Or Delay Lower-Cost Generic Prescription Drugs

Over the past few years, the national headlines have been dominated by stories about the high cost of pharmaceuticals.  We have seen jaw-dropping examples, such as the unconscionable price increase overnight by Turing Pharmaceuticals of their drug for patients with HIV, from $13.50 to $750 per pill. 

Pharmaceutical companies should be compensated for their important work developing lifesaving treatments.  But when companies engage in predatory practices at the expense of consumers, we must act. That is why today I am re-introducing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, bipartisan legislation to end inappropriate delay tactics that are used by some brand-name drug manufacturers to block competition from more affordable generic drugs.  I am glad to be joined by Senators Grassley, Klobuchar, Lee, and Feinstein, and several other Senators of both parties in introducing this bill today. 

The first delay tactic addressed by the CREATES Act involves the withholding of drug samples that generic manufacturers need to gain regulatory approval.  Federal law requires generic competitors to prove that their low-cost alternative is equally safe and effective as the brand-name drug with which they wish to compete.  Unfortunately, some brand-name companies are preventing generic manufacturers from obtaining the samples they need to make the necessary comparison.  This simple delay tactic uses regulatory safeguards as a weapon to block competition.  The FDA has reported receiving more than 100 inquiries from generic product developers who were unable to access samples of a brand-name drug to compare their generic product.

The second delay tactic addressed by the CREATES Act involves the development of shared safety protocols.  For some high-risk drugs, federal law requires a generic drug manufacturer to join the brand-name drug manufacturer in a single, shared safety protocol for distribution of the drug.  Despite this requirement, some brand-name companies are refusing to negotiate shared safety protocols with potential generic competitors, again undermining those competitors’ ability to gain FDA approval for their generic versions of such drugs.

The revised version of the CREATES Act also allows the FDA more discretion to approve alternative safety protocols, rather than require parties to develop shared safety protocols.  Any safety protocol approved by the FDA must meet the rigorous statutory standards already in place.

These exclusionary practices thwart competition and deny consumers the benefit of lower drug prices.  I share the concerns of Vermonters and Americans across the country that many prescription drugs are simply too expensive.  When brand companies can artificially raise the price of drugs by using predatory practices, patients suffer.  Illnesses get worse.  Families, government programs, and other payers in the healthcare system ultimately bear those added, unnecessary costs.  

This legislation is not a silver bullet to address all of the complex problems driving the high costs of medications.  In addition to the delayed entry of generic drugs, I am troubled by the rising cost of treatments for opioid overdoses, which remain expensive for local law enforcement agencies, even though there are generic competitors.  In Vermont, many patients are grappling with the extremely high cost of a new drug for Hepatitis C that will likely have years of market exclusivity before generic alternatives can be made.  Last year we learned the price of EpiPens had increased by almost 500 percent since 2009, now costing roughly $600 for a two-pack.  The sharp increase in price combined with the relatively short shelf life of the product one year to 18 months has put this lifesaving drug out of reach for many. 

Think for a moment about the impact of price hikes on the family of a patient facing a life-threatening illness.  Across the country, hardworking Americans feel like the system is rigged against them by corporations that are looking to make a profit at any price.  With examples like Turing and Mylan, it is no wonder they feel that way.

The CREATES Act is one piece of the puzzle, addressing anticompetitive behavior that delays the creation of affordable generic drugs.  Drug affordability is a bipartisan issue that affects each and every American.  These reforms will make a difference.  I hope other Senators will join us in supporting these bipartisan reforms. 

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