Congress Introduces FAST Generic Act

Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) have introduced a bill, the Fair Access for Safe and Timely (FAST) Generics Act, in the hopes of shutting down loopholes in the Risk Evaluation and Mitigation Strategies (REMS), which was introduced in 2007 to allow branded pharmaceutical companies to restrict market access for generic alternatives.

REMS was originally intended to ensure public safety and restrict the distribution of dangerous or highly addictive drugs, but according to generic pharmaceutical developers, the letter of the law is being exploited to prevent or delay generics from coming to market.

Current U.S. law requires that a generic manufacturer must test its proposed generic against existing name-brand products, and in order to conduct these tests, a sample of the name-brand product is required. Name-brand drug innovators are using existing safety measures as an excuse to block the flow of products to wholesalers whom generic companies rely on to acquire testing samples.

A study conducted by Matrix Global Advisors concludes that the advantage, in this instance, is simply too high to be tolerated by the FDA.

According to the study which examined data from eight generic drug companies in possession of a product covered by REMS and currently under investigation, “Government, consumers, and private payors are already missing out on sizeable health care savings from the misuse of these programs (REMS).” Matrix Global estimates the lost savings at nearly $5.4B.

FAST Generics Act would amend existing laws to ensure that generic drug companies had fair and competitive access to samples required for safety and equality testing. Under the new provisions, license holders would be subject to anti-trust liability for failure to adhere to requirements.

Many brand-name drug developers and manufacturers argue it is the right of a drug innovator to restrict access to supplies of their drugs because safety tests, conducted on humans, would be out of their control. Many companies fear liability in studies that are not conducted properly.

According to the FDA Law Blog, the FAST Generics act would release license holders from potential liabilities by giving the FDA a final say on which developers are eligible for transfer.

Stivers said in a press release, “We cannot afford to promote practices that hinder consumers’ abilities to obtain generic alternatives to expensive brand medicines. This problem must be addressed to save the government and consumers billions of dollars while increasing pharmaceutical options for patients.”