Rep. Steve Stivers (R-Ohio) and Rep. Peter Welch (D-Vt.) have re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to what they say will increase consumer access to generic drugs, boost market competition and ultimately save consumers money.
Rep. Steve Stivers (R-Ohio) and Rep. Peter Welch (D-Vt.) have re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to what they say will increase consumer access to generic drugs, boost market competition and ultimately save consumers money.
Rooney
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The FAST Generics Act addresses issues with FDA’s Risk Evaluation and Mitigation Strategies (REMS) program.
“This is an important safety program that is meant to ensure the benefits of a drug or biological product outweigh its risks, but contains an unintended loophole currently being misused by some pharmaceutical companies to avoid competition,” said Curtis Rooney, President of the Healthcare Supply Chain Association (HSCA), one of the supporters of the Act.
When Congress passed legislation in 2007 authorizing the REMS program, it understood that companies could use these programs to delay generic competition, according to Rooney. An element of the REMS program includes the Assure Safe Use (ETASU) requirements. These requirements are being misused to delay generic competition for REMS and non-REMS products alike, according to Rooney.
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“What Congress did not foresee is that companies would use a loophole in the program to deny generic and biosimilar manufacturers access to product samples required to obtain FDA approval and bring their less-expensive products to market,” he said.
According to Rooney, there are 4 ways the FAST Generics Act will help the healthcare industry:
“These samples are needed to obtain FDA approval but are being hidden behind a wall created by restricted distribution networks,” Rooney said. “These abuses are growing, resulting in delays of generic and biosimilar products being brought to market.”