CSRxP: U.S. SUPREME COURT DECISION HELPS SAFEGUARDS CRITICAL PATHWAY FOR GENERIC COMPETITION

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. Ruling Will Help Protect Skinny-Label Pathway from Big Pharma Attempts to Exploit Loopholes

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released the following statement in response to a decision by the U.S. Supreme Court Thursday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. The U.S. Supreme Court ruled 9-0 in favor of Hikma Pharmaceuticals.

“Today’s U.S. Supreme Court decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. will help safeguard a critical pathway for generic competition,” said CSRxP executive director Lauren Aronson. “Big Pharma has sought to exploit legal loopholes in the skinny label pathway as another tactic in an egregious anti-competitive playbook to block and delay more affordable alternatives to high-priced brand name drugs from entering the market and lowering prices for American consumers.”

“This decision helps restore certainty to the skinny-label pathway and will encourage more lower-cost generic competition to enter the market more quickly,” Aronson continued. “Congress should further provide certainty and regulatory clarity around the skinny label pathway and support greater generic competition to lower drug prices by advancing the bipartisan Skinny Labels, Big Savings Act, and passing additional market-based solutions to crack down on Big Pharma’s anti-competitive practices that keep drug prices high in America.”

The Supreme Court decision helps protect access to safe, lower-cost generic drugs by safeguarding ‘skinny labeling,’ a longstanding process by which generic manufacturers carve out patented uses from a drug’s U.S. Food and Drug Administration (FDA) label so lower-cost generics can be approved earlier for non-patented uses. Skinny-label generics saved Medicare Part D nearly $15 billion on just 15 drugs.

Read the full U.S. Supreme Court opinion HERE. 

Read more about the Skinny Labels, Big Savings Act HERE.

Read more about solutions Congress can advance that would further encourage generic and biosimilar competition HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.