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Welch, McKinley Introduce Bipartisan Bill to Increase Consumer Access, Drive Down Costs, and Boost Market Competition for Generic Pharmaceuticals

April 7, 2017
Press Release

WASHINGTON—Rep. Peter Welch (D-VT) and Rep. David McKinley (R-WV)this week introduced the Fair Access for Safe and Timely (FAST) Generics Act. The legislation would thwart manipulation of the Food and Drug Administration’s (FDA) drug safety regulations in order to block the production of generic alternatives to brand name medicines. This would increase consumer access to generic drugs, boost market competition, and ultimately save consumers money.

“Generic prescription drugs are very often a cost-effective alternative to brand name drugs. Patients, in consultation with their physician, should have a choice where possible,” said Welch. “Our legislation will save consumers billions of dollars by ensuring timely competition in the market and preventing unfair delays for patients seeking more affordable options for their medications.”

“The high cost of brand name drugs should never force patients to make painful financial decisions. Medicine must be affordable to those who need it most,” said McKinley. “Our bipartisan bill will allow more people to access generic alternatives by providing competition in the marketplace and removing unnecessary bureaucratic delays from the federal government,” McKinley said.

Currently, there are companies that abuse Food and Drug Administration (FDA) drug safety programs by withholding access to drug samples for generic manufacturers, resulting in anticompetitive practices and increased pharmaceutical costs.

Specifically, the FAST Generics Act includes common-sense reforms to close these loopholes and address the most common abuses of Risk Evaluation and Mitigation Strategy (REMS) and non-REMS restricted access programs. These reforms provide a reasonable window for negotiations between manufacturers; limit the extent to which companies can delay competition; and minimize the burden on FDA, which has spent hundreds of hours adjudicating disputes between companies. In the last Congress, the bill received an informal Congressional Budget Office score, which estimated it would save taxpayers $2.35 billion dollars.