WASHINGTON — U.S. Sen. Patrick Leahy, D-Vt., introduced a bipartisan bill Thursday that aims to hasten the availability of generic prescription drugs to Americans by stripping away powers of brand-name pharmaceutical companies to stymie the research and development of off-brand prescriptions.
“Vermonters and American families across the nation know from hard experience that many prescription drugs are simply too expensive,” Leahy said in a statement Thursday. “Vermonters tell me that the high cost of prescription drugs has become their top health care concern. When brand companies can drive up the price of drugs through predatory practices, patients suffer. Illnesses worsen. Families, government programs, and other payers in the healthcare system ultimately bear those added, unnecessary costs.”
The legislation, entitled the Creating and Restoring Equal Access to Equivalent Samples [(CREATES) Act, targets two common practices of large drug companies. The first tactic is for large companies to prevent generic competitors from obtaining drug samples for comparative testing purposes. Without samples to prove the generic drug’s equivalency to the brand name drug, competitors are unable to gain approval from the Food and Drug Administration.
The second tactic, which also hampers FDA approval, involves large companies refusing to allow generic competitors to participate in the development and participation of safety guidelines for the drug.
The CREATES Act would allow generic drug makers to seek legal recourse if samples are not provided, and also grants the FDA more discretion in allowing generic drug makers to develop alternative safety protocols that, while still stringent, do not have to mirror exactly the large drug company rules.
Leahy is the leading sponsor of the legislation, which is co-sponsored by U.S. Sen. Chuck Grassley, R-Iowa, who has long served with the Vermont senator on the Judiciary Committee. Other sponsors include U.S. Sens. Dianne Feinstein, D-Calif., Amy Klobuchar, D-Minn., and Mike Lee, R-Utah.
Identical companion legislation in the House was introduced this week, also with bipartisan support.
The Congressional Budget Office estimates that the Leahy bill would save the federal government — one of the biggest drug purchasers in the world — roughly $3.3 billion by creating more availability of cheaper medicines. Leahy’s office estimates that billions more would be saved by consumers.
Leahy introduced similar legislation in 2016, and held hearings on the issue in the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Despite bipartisan support in 2016, the bill did not see much action.
The bill has attracted a wide variety of outside support, including from the conservative Heritage Foundation, the AARP and various interest groups representing doctors, hospitals and insurance companies.
“AARP is pleased to endorse the CREATES Act that would deter brand name pharmaceutical companies from participating in certain practices that can delay or block the availability of less expensive generic and biosimilar drugs,” said Greg Marchildon, Vermont’s AARP director, in a statement Thursday. “Left unchecked, these unnecessary delays could cost consumers, government programs, taxpayers and the healthcare system billions of dollars annually.”
No pharmaceutical companies have endorsed the legislation, and the industry poured more than $27.5 million into the pockets of Congress members in 2016, according to the Center for Responsive Politics.
Leahy, who received $63,500 from pharmaceutical and health companies during the 2016 election cycle, said the tactics used by pharmaceutical firms to delay the development of low cost drugs “cause real harm.”
“Drug affordability is a bipartisan issue that affects every American,” Leahy said. “This needs to be a high priority. I’m committed to working on behalf of Vermonters to see that the CREATES Act and other vital initiatives to address the high cost of prescription drugs are signed into law.”