A bipartisan pair of congressmen on Thursday proposed a bill in the U.S. House of Representatives to try to prevent drugmakers from blocking generic and biosimilar competitors.
The Fair Access Safety and Timely Generics Act of 2017 could save an estimated $5.4 billion a year in reduced drug costs by closing a regulatory loophole that would give generic drug makers a clear pathway for market entry, according Premier, a Charlotte, N.C.-based GPO and performance improvement company that supported the bill.
Some drugmakers have used the U.S. Food and Drug Administration's Risk Evaluation and Mitigation Strategies program to create closed distribution networks that bar competitors from accessing product samples they need to determine if their products are equivalent to the brand name version. FDA requires generic and biosimilar drug makers conduct those equivalency studies in order to secure drug approval.
“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,” said Rep. Peter Welch (D-Vt.), who re-introduced the FAST Generics Act with Rep. David McKinley (R-W.V.).
But biopharmaceutical research group PhRMA said it is concerned the bill could undermine FDA-approved programs and create safety concerns.
Under the proposed law, generic and biosimilar drug developers would have to obtain HHS approval to seek access of brand name drugs. Generic drug developers could request injunctive relief and seek damages if they are unfairly denied access to product samples.
“The FAST Generics Act is an essential tool for helping to ensure greater patient access to lifesaving therapies at the most affordable price,” Blair Childs, Premier's senior vice president of public affairs, said in a statement.
About 40 percent of new FDA approvals must go through the risk evaluation process and that is expected to increase, according to Alex Brill, an analyst at Matrix Global Advisors who calculated the potential economic impact of the bill.
The bill was first introduced to Congress in June 2015 and did not pass the House Energy and Commerce Health Subcommittee. In the last Congress, the bill received an informal Congressional Budget Office score that estimated it would save taxpayers $2.35 billion dollars.