Pro-generics access bill gets Senate subcommittee hearing
WASHINGTON — The Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights on Tuesday held a hearing on the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a piece of legislation that was introduced last week that could increase patient access to generics if passed.
The CREATES Act was introduced by Sens. Patrick Leahy, D-Vt.; Chuck Grassley, R-Iowa; Amy Klobuchar, D-Minn.; and Mike Lee, R-Utah, and is aimed at allowing generics makers access to a reference product that might be subject to a Risk Evaluation and Management Strategy (REMS) with Elements to Assure Safe USE, or is under a restricted distribution system. It would also allow for shared REMS negotiations.
The bill was met with praise from several groups, including the National Association of Chain Drug Stores (NACDS), Express Scripts, the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council and the Pharmaceutical care Management Association (PCMA), among others, in a letter sent to the bill sponsors on June 14. Additionally, GPhA representatives testified at Tuesday’s hearing.
“The CREATES Act provides essential relief and remedies when brand companies refuse to provide samples on commercially reasonable terms or drag their feet during shared REMS negotiations,” GPhA member and Amneal assistant general counsel Beth Zelnick Kaufman said at the hearing. “It will help make the promise of affordable medicine a reality for more Americans.”
Following the hearing, PCMA praised the subcommittee for taking action on the legislation, which furthers an issue that has been a priority among many industry groups.
“This legislation will help bring generics to market faster, which is key to reducing drug costs,” PCMA president and CEO Mark Merritt said.
GPhA president and CEO Chip Davis noted that the legislation holds promise when it comes to creating affordable alternatives to branded medicines.
“The CREATES Act is a bipartisan solution to stop REMS abuse and limit similar restrictions that certain branded drug makers use to limit competition,” Davis said. “GPhA is pleased that the Senate is choosing to shine a light on brand drug company ploys to block patient access to safe, effective and more affordable generic and biosimilar medicines. A diverse group of health experts, providers, stakeholders, economists, regulators and others recognize that a legislative remedy is needed to stop REMS abuse and encourages swift passage of the CREATES Act.”