Senate Judiciary Committee Advances CREATES Act

Regulatory NewsRegulatory News | 14 June 2018 |  By 

In a 16-5 vote, the Senate Judiciary Committee on Thursday voted to advance a bill aimed at increasing generic drug competition, known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
The bill will now be reported to the full Senate for consideration, however the House version of the bill, H.R. 2212 has yet to be taken up in committee this Congress.
First introduced in 2017, the CREATES Act is aimed at addressing tactics used by branded drugmakers to delay generic competition, such as restrictive distribution arrangements that prevent generic drugmakers from purchasing the samples needed to conduct bioequivalence testing.
"This bill targets abuses that undermine free market competition and the integrity of the Hatch-Waxman Act," Committee Chairman Chuck Grassley (R-IA) said.
Specifically, the bill would create a legal pathway for generic drugmakers to sue drugmakers for damages in disputes over access to samples and by giving the US Food and Drug Administration (FDA) the authority to approve separate comparable risk evaluation and mitigation strategies (REMS) for generics.
Sponsored by Sen. Patrick Leahy (D-VT), the bill has bipartisan support and is cosponsored by 28 Senators, including 14 Republicans, 13 Democrats and one Independent.
Three Republican sponsored amendments to the bill were not considered, though a Manager's Amendment was added to the bill.
According to Grassley, the changes in the Manager's Amendment were developed based on input from the US Food and Drug Administration (FDA), Federal Trade Commission and industry groups PhRMA and BIO.
"The amendment adds definition for commercially reasonable market-based terms, verifies that the sale of samples in accordance with the bill will not be a violation of REMS, clarifies the limitation of liability language and ensures that any shared system REMS waivers maintain the same level of items," Grassley said.
FDA has already taken steps to address both issues by naming branded drugmakers accused of restricting access to samples and by drafting guidance on developing shared REMS systems and detailing the circumstances in which it would consider waiving shared REMS requirements.
Chip Davis, president of the generic drug industry group the Association for Accessible Medicines (AAM) called the vote "a critical first step" toward addressing high drug prices.
The committee also voted to report a separate bill aimed at tackling opioid diversion, S. 2837 Preventing Drug Diversion Act of 2018, to the full Senate. Earlier this week the Senate Finance Committee voted unanimously to advance a package of bills in the Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act.
Hearing, Bill Text


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