May 31, 2018

Grassley: FDA Action on Prescription Drug Competition Good First Step

Congress must also act to improve access to more affordable prescription medications


WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) today reiterated the need for Congress to pass bipartisan measures aimed at improving competition in the prescription drug market and expand access to lower-cost generic medications. His statement followed newly-announced FDA guidance documents aimed at preventing brand name drug makers from delaying market entry of generic alternatives.

“I applaud the FDA Commissioner for his continued efforts to improve competition in the pharmaceutical industry and timely access to safe lower-cost generic prescription drugs. The new FDA guidance announced today calling for voluntary action by drug makers is an important step in the right direction, but this cannot be the end of our efforts to stop bad behavior by some drug companies. The bipartisan CREATES Act, which I’ve cosponsored, would require that brand name drug makers cooperate with generic manufacturers so that more affordable generic alternatives can be brought to the marketplace in a timely fashion. Congress should take up and pass this commonsense consumer-minded bill without further delay,” Grassley said.
 
Grassley is the lead cosponsor of S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a bill to combat anticompetitive practices used by some brand name pharmaceutical and biologic companies to block entry of lower-cost generic drugs by abusing the Risk Evaluation and Mitigation Strategy (REMS) requirements to withhold drug samples needed to develop and test generic equivalents.  The legislation is also estimated to reduce the federal deficit by $3.8 billion over ten years.
 
The CREATES Act allows for disputes over drug samples to be litigated under a clear and narrowly-tailored legal pathway in federal court.  By improving and streamlining existing litigation options, the legislation will actually send more parties to the bargaining table instead of the courtroom, ensuring timely resolution of disputes over sample testing and facilitating healthy competition in the marketplace, for the benefit all consumers. 
 
Grassley and his colleagues have previously called on the administration to work to boost competition in the prescription drug market to reduce costs for consumers.
 

-30-