Klobuchar Statement on Federal Trade Commission, NY Attorney General Complaint Against Vyera Pharmaceuticals, Martin Shkreli, and Others for Anticompetitive Scheme to Protect Massive Daraprim Price Increase
U.S. Senator Amy Klobuchar (D-MN) issued the following statement after the Federal Trade Commission (FTC) announced that it has filed a complaint in federal court against Vyera Pharmaceuticals, LLC, alleging an elaborate anticompetitive scheme to preserve a monopoly for the life-saving drug, Daraprim. In 2015, Klobuchar called on the FTC to investigate pharmaceutical companies for possible antitrust violations after the price of the drug Daraprim increased by more than 4,000 percent.
"After Turing Pharmaceuticals increased the price of the life-saving, infectious disease drug Daraprim by more than 4,000 percent, I called on the Federal Trade Commission to investigate whether pharmaceutical companies were restricting the distribution of their drugs to delay the approval of generic alternatives," Klobuchar said. "I am encouraged to see that the FTC and the Office of the New York Attorney General conducted such an investigation and decided to take action against the company, now known as Vyera Pharmaceuticals, and the people responsible for this brazen anticompetitive scheme. We need a fair and competitive drug marketplace to give consumers access to critical medication at prices they can afford. That means cracking down on anticompetitive conduct that limits or delays the introduction of more affordable generic and biosimilar alternatives."
Klobuchar has long supported efforts to combat anticompetitive tactics in pharmaceutical markets and to lower prescription drug costs by promoting free and fair drug competition.
Klobuchar was an original Senate sponsor of the CREATES Act, which became law in December 2019. Introduced in the Senate by Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Klobuchar, and Mike Lee (R-UT), the CREATES Act will combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs, including some of the practices implicated in the Daraprim complaint. The law addresses two types of delaying tactics: (1) when brand-name drug companies prevent potential generic competitors from obtaining samples of a product; and (2) when brand-name drug companies block their generic competitors from participating in shared safety programs to ensure drugs are used safely. Both of these tactics prevent generic companies from performing the necessary testing and distribution necessary for FDA approval. By combating these anticompetitive practices, the CREATES Act will help consumers access lower-cost generic drugs more quickly, saving billions of dollars.
The Preserve Access to Affordable Generics and Biosimilars Act, led in the Senate by Klobuchar and Grassley, would enhance the Federal Trade Commission's ability to crack down on anticompetitive patent settlement agreements in which branded pharmaceutical companies pay their competitors to delay the introduction of more affordable generic drugs and biosimilars. Deterring "pay-for-delay" deals would make some critical prescriptions more affordable for patients and reduce costs on our healthcare system.
The Stop STALLING Act, led in the Senate by Klobuchar and Grassley, would reduce the incentives for branded pharmaceutical companies to use the FDA petitioning process to interfere with the regulatory approval of generics and biosimilars that would compete with their own products, a tactic that delays patient access to more affordable medications. The bill would give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions. The bill passed the Senate Judiciary Committee in June 2019.