Renewed Push for CREATES Act as Budget Deadline Looms

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 is getting a renewed push—including a national ad campaign—from its supporters ahead of Congress’s February 8 deadline to fund the US government.

The bipartisan bill that seeks to spur drug price competition has languished since its June 2016 introduction to the Senate, but with President Trump’s recent focus on reducing the price of prescription medicines, the legislation is rumored to be under consideration for inclusion in a government funding package, which faces a deadline of this Thursday.

The bill, sponsored by Senator Patrick Leahy, D-Vermont, would allow a generic or biosimilar drug developer to bring a civil action against the license holder of a reference drug if the latter declines to make available enough samples for testing as part of generic or biosimilar drug development. Similarly, it could bring an action if the reference product’s sponsor fails to agree upon (or allow a competitor to join) a single, shared system of risk evaluation and mitigation strategies with elements to assure safe use of the drug.

A range of stakeholders have voiced concerns in recent months over the ability of reference product sponsors to withhold adequate samples of their drugs for testing, saying that these are defensive strategies to retain market share for originator products that effectively block generics and biosimilars from reaching the marketplace and creating meaningful price competition. A number of organizations, including the Association for Accessible Medicines, AARP, and the American College of Physicians, among others, see the CREATES Act as a viable solution to what they call anti-competitive practices.

Among the most vocal supporters of the bill is former Representative Henry Waxman, D-California, who co-sponsored (with Senator Orrin Hatch, R-Utah) the legal foundation for the US generics drug market: The Drug Price Competition and Patent Term Restoration Act of 1984, referred to colloquially as “Hatch-Waxman.”

Waxman told The Center for Biosimilars^® in an email that the CREATES Act “…Tackles one of the numerous problems driving high drug prices—drug manufacturers’ use of anti-competitive tactics to block access to generic drugs. If passed, the CREATES Act would increase the development and availability of generic drugs. Not only is it good policy, but it could save patients more than $5 billion and the federal government more than $3 billion over 10 years, helping to pay for other necessary federal spending, including Community Health Centers.”

Waxman added that “Taking these steps to counter generic delay tactics could help address one of the factors driving high prescription drug prices. Such action may also serve as an important opening for further conversations on how we can regain the balance of incentives for drug innovation and competition that was established under the Hatch-Waxman Act.”

Despite broad support, the CREATES Act has some detractors; Wayne Wintergarden, PhD, of the consulting firm Arduin, Laffer & Moore Econometrics, wrote in Forbes that the proposed legislation is a “gift to trial lawyers” that will result in a flurry of new litigation rather than a speedier path to generic and biosimilar development and market entry.