Pharmaceutical companies would be deterred from preventing cheaper generic alternatives from going to market under bipartisan, bicameral legislation led by U.S. Rep. Tom Marino (R-PA) and U.S. Sen. Chuck Grassley (R-IA) last week.
The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act takes aim at tactics used to delay the entry of generic drugs into the marketplace, contributing to rising drug prices.
“The CREATES Act will lead to lower costs for patients by ensuring that they have access to safe and effective FDA approved generic medicines,” said Marino, the chairman of the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law. “It will also ensure consumer safety by maintaining safeguard features of the Risk Evaluation and Mitigation Strategies (REMS) Program while closing regulatory loopholes that are used to keep prices artificially high.”
The CREATES Act would address two specific delay tactics: drug companies preventing makers of generics from obtaining samples of branded products in order to demonstrate that a generic is equivalent, and when manufacturers of branded products refuse generic competitors access to distribution safety protocols.
“I frequently hear from Iowans about the high price of prescription drugs,” Grassley, the chairman of the Senate Judiciary Committee, said. “Many Americans rely on more affordable generic medications once patents have expired for brand-name drugs. Unfortunately, we’re seeing some brand-name drug companies engage in anti-competitive tactics that delay entry of lower cost generic drugs into the market. This bill takes important steps to improve the current system so that consumers have access to less expensive generic drugs in a timely fashion.”
Under the CREATES Act, makers of generic medicines would be able to petition federal courts for relief when they face sample-sharing delay tactics, and judges would be authorized to award damages to further deter delays.
The FDA would also have more ability to approve alternative safety protocols when a branded drug maker blocks generic competitors from accessing distribution safety protocols.
The legislation received bipartisan support, with Sen. Patrick Leahy (D-VT) sponsoring the legislation in the Senate and Rep. David Cicilline (D-RI) helping to introduce the bill in the House.
The CREATES Act would lead to a $3.3 billion net decrease in the federal deficit and lead to even more savings among private insurers and consumers, the Congressional Budget Office estimates.