US lawmakers re-introduce FAST Generics Act

US Representative Steve Stivers (Republican, Ohio) yesterday joined Rep Peter Welch (Democrat, Vermont) to re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money.

“My bill closes federal loopholes to ensure consumers have faster access to less costly generic drugs by increasing market competition and eliminating bureaucratic red tape,” said Rep Stivers. Currently, there are companies that abuse Food and Drug Administration drug safety programs by withholding access to drug samples for generic manufacturers, resulting in anticompetitive practices and increased pharmaceutical costs, stated.

Aims to address abuse of REMS and non-REMS programs

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.

“Generic prescription drugs are often a cost-effective alternative to brand name drugs. Patients, in consultation with their physician, should have a choice where possible,” said Rep Welch, adding: “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.”

According to a study conducted by Matrix Global Advisors, companies using FDA safety programs as a smokescreen for these practices are costing American consumers $5.4 billion annually, including a lost savings of $1.8 billion for the federal government, the lawmakers stated.

Move welcomed by generics group GPhA

Responding to the news, Ralph Neas, president and chief executive of the Generic Pharmaceutical Association (GPhA), said: “This bipartisan bill would close loopholes that allow some drug companies to misuse the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) programs and other non-FDA mandated restricted access programs to thwart competition from more affordable generic drugs….Should these practices extend to biosimilars, $140 million in savings would be lost for every $1 billion in biologics sales, according to a study by Matrix Global Advisors.”