US: Senators introduce bill aimed at getting generic drugs to market

Four US senators – two Democrats and two Republicans – introduced a bill on Tuesday aimed at preventing big pharmaceutical companies from using safety rules to prevent generic drugs from coming to market.

Senators Charles Grassley, chair of the Judiciary Committee, and Patrick Leahy, the top Democrat, are sponsors of the bill along with Senators Mike Lee and Amy Klobuchar, the chair of the antitrust subcommittee and top Democrat, respectively.

The Food and Drug Administration, which ensures the safety of the country’s food and drug supply, has a risk evaluation and mitigation strategy program, called REMS, which is designed to ensure that the riskiest drugs are dispensed safely.

But there have been complaints that the program has been misused by brand-name drug companies to prevent generic manufacturers from getting the drug samples needed to market cheaper versions. Generic companies also complain their drugs are not allowed to share a safety protocol, making it difficult to come to market.

The bill would allow a generic manufacturer who faces either of these situations to file a lawsuit to force access to a sample or force negotiations for a safety protocol.

“Balancing the cost of developing lifesaving medications with the need to make available affordable prescription drugs to consumers has always been a difficult task. It’s a consistent topic at my town meetings,” Grassley said in a statement.

Full Content: Reuters

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