Statement of Senator Patrick Leahy On Introduction of the Creating and Restoring Equal Access to Equivalent Samples (CREATES)

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

June 14, 2016

In recent months, the high cost of pharmaceutical products has been front and center in national news, sometimes with astonishing examples like the unconscionable price-hike by Turing Pharmaceuticals of their drug for patients with HIV from $13.50 to $750 per pill overnight.

Pharmaceutical companies should be compensated for their important work developing life-saving treatments, but when companies engage in predatory practices at the expense of consumers, we must act. That is why today, I am 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.

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 a shared safety protocol with potential generic competitors, again undermining those competitors’ ability to gain FDA approval for their generic version of the drug.

These exclusionary practices thwart competition and deny consumers the benefit of lower drug prices. They also undermine the careful balance created in the Hatch-Waxman Act and the more recent Biologics Price Competition and Innovation Act, which are designed to reward and incentivize innovation while ensuring that consumers ultimately benefit from the entry, after an appropriate time, of generic or biosimilar versions of a drug. Innovative companies can and should gain the benefit of their inventions. But when companies artificially extend the period of those benefits by using dilatory tactics to delay generic entry, the thoughtful balance of the Hatch-Waxman Act and BPCIA are plainly undermined.

I share the concerns of Vermonters and Americans across the country that many pharmaceutical products are simply too expensive for consumers. Nearly three-quarters of the public view prescription drug costs as unreasonable, and one in four patients say they have not filled a prescription because of cost. Parents should not be forced to choose between putting food on the table and getting their children and themselves the medicine they need. When drug prices are artificially inflated, patients suffer, illnesses become protracted, and families, government programs, and other payers in the healthcare system ultimately bear the cost. That is why this legislation is supported by consumer groups, physicians, insurance companies, pharmacists and hospitals who all see firsthand the impact of unreasonably high costs of some prescription drugs.

Earlier this month, Vermont set an example for the Nation when it passed into law drug transparency legislation that will require pharmaceutical companies to justify large increases in their drug prices. Here in Washington, the Senate Aging Committee and other Committees have been doing important work to analyze the root causes of high drug pricing and find practical solutions. Solving this issue will require nuanced, thoughtful work on all sides to ensure that consumers are protected and that pharmaceutical companies that act in good faith can continue to innovate for patients.

With the CREATES Act, the bipartisan leaders of the Senate Judiciary Committee and its Subcommittee on Antitrust, Competition Policy and Consumer Rights are using our roles to address anticompetitive behavior that blocks competition and delays the creation of affordable generic drugs. I thank Senators Grassley, Klobuchar and Lee for joining me in this effort, and for agreeing to hold a hearing on this bill as soon as next week.

Drug affordability is a bipartisan issue that impacts each and every one of us. I hope other Senators will join us in supporting this bipartisan legislation.


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