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

February 5, 2019
Press Release

WASHINGTON—Rep. Peter Welch (D-Vt.) and Rep. David McKinley (R-W.Va.) today 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. The FAST Generics Act is cosponsored by Rep. David Cicilline (D-R.I.).

“In a time of skyrocketing prescription drug costs, generic drugs are 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 prescription drugs requires many Americans to make difficult financial decisions for themselves and their families. The FAST Generics Act will help provide patient access to lifesaving medications at affordable prices,” McKinley said. “Families should never have to decide between affording their medications and grocery shopping or filling up their gas tanks. This legislation will prevent pharmaceutical companies from blocking affordable alternatives from entering the market and will help Americans keep money in their pockets.”

“No one should go broke because they can’t afford the cost of their prescription drugs. What pharmaceutical companies are doing is unconscionable. It needs to end,” said Cicilline. “I’m pleased to co-sponsor Congressman Welch’s proposal and I look forward to continuing our work together to bring down the cost of prescription drugs.”

Currently, there are pharmaceutical 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 for consumers.

Specifically, the FAST Generics Act includes commonsense 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. Previously, the bill has received an informal Congressional Budget Office score, which estimated it would save taxpayers $2.35 billion dollars.