“CREATES Act” is Nothing but a Giveaway to Well-Heeled Personal Injury Lawyers

The United States Senate is currently considering legislation that would benefit trial lawyers at the expense of consumers and innovative drug manufacturers. Proponents claim the Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act (Pat Leahy D-VT) would provide a more efficient path for generic drug manufacturers to bring their product to market.  In reality, the legislation is nothing but a giveaway to greedy personal injury lawyers and generic drug manufacturers.

Among the most troubling aspects of the bill is the damage it would cause to a regulatory system that is essential to facilitating the development of new medicines and treatments.  The CREATES Act seeks to alter a regulatory process known as Risk Evaluation and Mitigation Strategies (REMS).  The process exists to maintain safety standards and promote innovation.  The legislation would open the door to increased litigation by establishing a private right of action when generic manufacturers seek samples from innovative drug companies.  These monetary damages would provide an incentive for generic drug companies to delay negotiations over appropriate sample transfers and sue in an effort to obtain windfall settlements.

Also troubling is the bill’s blatant disregard for intellectual property rights.  Without sufficient patent protection, innovators will not be appropriately incentivized to create the treatments that patients need.  The CREATES Act empowers generic manufacturers, and profit-seeking personal injury lawyers, to force brand-name drug companies into giving up their intellectual property rights.

For a bill that claims to benefit consumers, the CREATES Act contains a long list of questionable policies with two absolute certainties – consumers will see the development of fewer life-saving medicines and personal injury lawyers will profit from increased litigation against innovative drug companies.