The Preserve Access to Affordable Generics Act would increase consumers’ access to cost-saving generic drugs by helping put an end to pay-offs by brand-name drug manufacturers that keep cheaper generic equivalents off the market
WASHINGTON, DC – U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) today introduced bipartisan legislation to crack down on anti-competitive pay-for-delay pharmaceutical deals. The Preserve Access to Affordable Generics Act would crack down on anti-competitive pay-offs in which branded companies pay their generic competitors not to compete as part of a patent settlement. These pay-off settlements (also known as “reverse payments”) delay consumer access to generic drugs, which can be as much as 90 percent cheaper than brand-name drugs. The legislation would stop these anti-competitive pay-off agreements to keep more affordable generic equivalents off the market and make sure consumers have access to the cost saving generics they need.
“Outrageous pay-for-delay pharmaceutical deals thwart competition and raise prescription drug prices for consumers,” Klobuchar said. “Our legislation would put an end this harmful practice that keeps generic drugs off the market. I’ll continue to push to ensure that consumers have access to the drugs they need at a price they can afford.”
“When brand-name drug makers and generic manufacturers enter into agreements to keep more affordable medicines out of the marketplace, all of us are left to pay the price. This anti-competitive practice results in artificially high drug prices for consumers and taxpayers, and short-circuits laws in place to expedite access to less-costly medications. This bill would prevent drug companies from engaging in these abusive dealings and ensures more timely access to affordable medicines for patients and taxpayers,” Grassley said.
Klobuchar and Grassley introduced similar legislation last Congress following a Federal Trade Commission report demonstrating that a significant number of potential pay-for-delay settlements continue to occur.
Klobuchar has championed efforts to address the high cost of prescription drugs, authoring multiple pieces of legislation that would protect American consumers. She introduced the Medicare Prescription Drug Price Negotiation Act, which would allow for Medicare to negotiate the best possible price of prescription drugs. Klobuchar joined with Senators Grassley, Patrick Leahy (D-VT), and Mike Lee (R-UT) to introduce the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. In addition, Klobuchar introduced the Safe and Affordable Drugs from Canada Act with Senator John McCain (R-AZ) that would require the Food and Drug Administration to establish a personal importation program that would allow individuals to import a 90-day supply of prescription drugs from an approved Canadian pharmacy.
Grassley introduced the bipartisan CREATES Act with Klobuchar and others to prevent brand name drug makers from restricting access to samples for product testing for generic manufacturers, which can delay generic drugs from entering the marketplace. Grassley has advocated for lifting importation restrictions on prescription medications, allowing for greater competition in the marketplace, and voted for such reforms during a budget resolution debate earlier this week. He also led an investigation into the business practices of Mylan, a drug company that dramatically increased the price of the life-saving EpiPen. The company also overcharged taxpayers by misrepresenting its product to the Centers for Medicare and Medicaid Services. He also called on the Federal Trade Commission to look into whether drug makers are engaged in anticompetitive behaviors that drive up the price of prescription medications, and urged President-elect Trump to prioritize efforts to improve competition in the prescription drug market to help bring down prices for consumers.