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Leahy and Marino Push for Creates Act to be Added to Omnibus

Posted 28 February 2018 | By Zachary Brennan 

Leahy and Marino Push for Creates Act to be Added to Omnibus

Sen. Patrick Leahy (D-VT) and Rep. Tom Marino (R-PA) on Wednesday called for the passage of the Creates Act to help increase generic drug competition and lower drug prices.

Marino said in a call with reporters that he has spoken with House leadership and that the Creates Act will likely be added to the omnibus, which Congress has until 23 March to put together and pass before another government shutdown. Leahy also noted that the Creates Act was included in the last spending bill to fund the government but then was pulled after lobbyists targeted it.

The bill, known officially as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and supported by generic industry group AAM, was re-introduced last April in the House and Senate. The bill aims to target sample sharing – when brand-name drugmakers prevent generic firms from obtaining samples of the branded products so the generic company cannot perform necessary bioequivalence tests -- and shared safety protocols – when brand-name manufacturers whose products require a distribution safety protocol, known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or “REMS with ETASU,” and refuse to allow generic companies to participate in that safety protocol.

According to the Senate bill’s text, Janet Woodcock, director of the Center for Drug Evaluation and Research at the US Food and Drug Administration, has testified that some manufacturers have used REMS and distribution restrictions as reasons to not sell quantities of a covered product to generic product developers, causing barriers and delays in getting generic products on the market. 

In a note to investors on Monday, Bernstein biotech analyst Ronny Gal also said he spoke to a generic drug company executive, who wished to remain anonymous, but who explained how specialty pharmacies often will not jeopardize their lucrative relationships with brand drug companies and are unwilling to sell product to generic companies.

“Sometimes you just get partial bottles, or had to pay $1,000+ per pill, so just the RLD [reference listed drug] for the biostudy could cost $500k-$1mil,” according to Gal’s quote of the executive.

Categories: Regulatory News

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