FAST Generics Act Reintroduced in Congress

Pharmacy Times, September 2015 Specialty Pharmacy, Volume 81, Issue 9

The bipartisan Fair Access for Safe and Timely Generics Act has been introduced in Congress.

The bipartisan Fair Access for Safe and Timely (FAST) Generics Act has been introduced in Congress. In late June, Reps. Steve Stirers (R-OH) and Peter Welch (D-VT) reintroduced the FAST Generics Act in the US House of Representatives—just 9 months after the same bill died in the last Congress.

A press release from Rep. Stiver’s office says the objectives of the bill are “to increase consumer access to generic drugs, boost market competition, and ultimately save consumers money.

In a letter of support from a coalition that includes the Generic Pharmaceutical Association (GPhA), Express Scripts, the Healthcare Supply Chain Association, and the National Association of Chain Drug Stores, the pharmaceutical industry stakeholders called the FAST Generics Act a “commonsense measure that prioritizes patient safety and public health.”

This latest iteration of the FAST Generics Act differs from the earlier version in that the Risk Evaluation and Mitigation Strategies (REMS) reform issue has since gained more traction. Following the Affordable Care Act’s recent win in the Supreme Court, the growing debate about the true value of expensive specialty drugs and the passage of the 21st Century Cures Initiative in the House, the current health policy climate is likely more favorable for the FAST bill.

Ralph Neas, CEO and president of GPhA, said in a recent press release that the organization “applauds” the bill, which “would close loopholes that allow some drug companies to misuse the FDA’s REMS programs and other non- FDA-mandated restricted-access programs to thwart competition from more affordable generic drugs.” The FAST Generics Act “sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers,” while also “putting safeguards in place to protect public health,” Neas said.

The “loophole” refers to a company’s ability to employ restricteddistribution networks to block manufacturers’ market entry—a tactic that initially grew from the REMS Elements to Assure Safe Use (ETASU).

If enacted, the legislation would position the Department of Health and Human Services (HHS) to serve as the go-between for the generics industry and brand manufacturers. Generics companies would first seek HHS authorization before submitting a request and authorization to a brand manufacturer. Additionally, they would also have injunctive relief and the ability to seek damages from free parties in situations in which they are unduly denied access to product samples.

The FAST Generics Act is also billed as a cost-saving measure. A July 2014 analysis from Matrix Global Advisors found that using restricted-access programs to create hurdles for generic competition costs the US health care system $5.4 billion per year, including $1.8 billion from the federal government. The firm also forecasted that if companies expand this practice to the forthcoming biosimilars market, there would be nearly $140 million in lost savings per $1 billion in biologics sale.

On the opposite side of the debate, strong REMS advocates allege that the oversight is necessary for drugs known to carry very high risks and that the FAST Generics Act would dilute important safety mechanisms. A recent blog post on the Health Affairs website written in support of strong REMS notes that of the 70-plus drugs now authorized to have unique REMS programs in place, only around 30 are subject to the more restrictive ETASU requirements. The post also noted that more than a dozen drugs subject to REMS requirements have gone generic—including 9 with ETASU provisions. This, the blog’s authors allege, serves as evidence that REMS do not impede on the development of generics.

The legislation will now be considered by the House Energy and Commerce Committee.