WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley, along with Senators Patrick Leahy, Mike Lee and Amy Klobuchar, is pushing to include legislation that would combat rising drug prices for Iowans by deterring brand-name pharmaceutical companies from blocking the entrance of more affordable generic alternatives in the marketplace in the 21st Century CURES bill being debated in the Senate.
“The rising price of prescription drugs is having a major impact on families and seniors everywhere. Some brand-name drug companies are engaging in anti-competitive tactics that delay entry of lower cost generic drugs into the market, and this tactic is becoming more common,” Grassley said. “We need to start taking steps to ensure that our laws are not frustrated and consumers have access to less expensive generic drugs in a timely fashion.”
The stand-alone bill, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, was introduced in June. Currently the FDA has a streamlined approval process whereby generic drug companies can conduct testing of generic versions of a brand-name drug prior to its patent expiration. However, concerns have been raised that some brand-name companies are misusing an FDA program, known as the Risk Evaluation and Mitigation Strategy (REMS), to thwart that process by preventing the sale of samples of their product and refusing to allow generic competitors to participate in their REMS protocol. These tactics result in blocking generic drug approval and keeping drug prices high for consumers. The CREATES Act addresses this anticompetitive behavior by giving generic companies an opportunity to obtain relief in a timely fashion rather than through lengthy antitrust litigation.
The amendment filed by the senators refines the CREATES Act text to ensure patient safety by allowing the FDA to require additional information before approving a request for samples of high risk drugs, and by giving the FDA authority to more easily approve safety protocols.
Grassley is also the co-author of the Preserve Access to Affordable Generics Act which would make sure consumers have access to cost-saving generic drugs by making it illegal for brand-name and generic drug manufacturers to enter into anti-competitive pay-off agreements.