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Senators introduce bill aimed at getting generic drugs to market
Source: Reuters
Life | Tue Jun 14, 2016 6:44pm EDT
Senators introduce bill aimed at getting generic drugs to market
WASHINGTON | BY DIANE BARTZ
Four U.S. 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.
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Senators introduce bill aimed at getting generic drugs to market
WASHINGTON | BY DIANE BARTZ
Four U.S. 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.
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Read more: http://www.reuters.com/article/us-congress-pharmaceuticals-genericdrugs-idUSKCN0Z02RM