Senators Call for Supporting Drug Pricing Law After REMS Reform Stalls

A recent op-ed in STAT written by Senators Chuck Grassley (R-Iowa) and Patty Leahy (D-Vermont) argued for legislation to fix loopholes in the Risk Evaluation and Mitigation Strategy (REMS) process, which currently allows drugmakers to stall the process through which cheaper generic drugs come to the market.

“Prices continue to skyrocket as companies making brand-name drugs restrict competition by refusing to share samples of their drugs with companies aiming to make generic versions or refusing to negotiate a shared safety protocol,” Senators Grassley and Leahy wrote. “This is an abuse of government regulations that are intended to protect patients and ensure drug safety.”

Under the REMS process, generic manufacturers must develop a shared system REMS with the innovator product, and in order to develop these safety plans, the manufacturers of the generics need access to brand-name samples from the original manufacturer. However, by withholding access to the required samples, the original manufacturers can draw out the process and prevent generic competitors from coming to the market.

The FDA, recently announced ways it was going to reduce abuses of the REMS process; however, legislation is required in order to completely stop abuses of this process.

“My message is this: end the shenanigans,” Scott Gottlieb, MD, commissioner of the FDA, recently said while addressing the need for REMS reform. “Branded companies’ use of REMS – which FDA adopts as a way to ensure the safe use of certain drugs – is also sometimes being used as a way to frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies. This needs to stop.”

As a result, a bipartisan group of Senators, including Mike Lee (R-Utah), Ted Cruz (R-Texas), Rand Paul (R-Kentucky), Amy Klobuchar (D-Minnesota), Dianne Feinstein (D-California), Dick Durbin (D-Illinois), and Sens Grassley and Leahy creates the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

“Our bipartisan bill targets anti-competitive behavior that keeps prices artificially high, such as when companies withhold drug samples from generic manufacturers or refuse to negotiate a shared safety protocol,” they wrote. “Both steps undermine the FDA approval process and block potential generic competitors from creating less-expensive alternatives.”

They also argue that pharmaceutical lobbyist who are currently attacking the bill by claiming it will lead to frivolous lawsuits against drugmakers, are misleading the public. They noted that the CREATES bill is crafted to only allow certain eligible manufacturers to sue only after they have been authorized to do so by the FDA.

According to the op-ed, the CREATES act would save the federal government $3.8 billion by 2028.

“The CREATES Act is a sensible, efficient, market-based way for generic drug manufacturers to address the delays in developing generics without jeopardizing patient safety or creating lengthy battles in the courts,” Senators Grassley and Leahy concluded. “There is no question that pharmaceutical companies should be compensated for their important work developing lifesaving treatments. But they should not be allowed to use predatory practices to cling to their patents and delay the development of generics at the expense of their customers.”

—David Costill

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