4 ways the FAST Generics Act will help healthcare

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:

• The FAST Generics Act will create greater competition under the framework of the Hatch-Waxman Act.
  “Lack of competition is costing patients, the federal government and the healthcare system billions of dollars annually,” Rooney said.

• A July 2014 analysis by Matrix Global Advisors found that using restricted access programs to prevent generic competition costs the healthcare system $5.4 billion annually, including $1.8 billion to the federal government.

• As companies expand this practice to biosimilars, it could result in approximately $140 million in lost savings for every $1 billion in biologics sales. The FAST Generics bill would apply to both generics and biosimilar drugs, therefore preventing this from occurring in the future.

• The FAST Generics Act establishes clear processes to facilitate the provision of samples to generic manufacturers and prevent companies from denying the implementation of shared REMS programs. It defines certain anticompetitive practices with respect to restricted access programs, therefore closing the existing loophole around current REMS prohibitions.

“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.”

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