Antitrust Law Daily Bipartisan legislation aimed at promoting generic drug competition reintroduced
Tuesday, February 5, 2019

Bipartisan legislation aimed at promoting generic drug competition reintroduced

By Jeffrey May, J.D.

The proposed CREATES Act is intended to combat anticompetitive delay tactics used by some brand-name pharmaceutical and biologic companies to block cheaper generic alternatives from entering the marketplace.

Leading members of the House and Senate Judiciary Committees have reintroduced the proposed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. The measure, which has strong bi-partisan support, is aimed at rising prescription drug prices.

The CREATES Act would address two so-called delay tactics that are purportedly employed by some brand-name drug companies against potential biosimilar and generic competitors. First, as its name implies, the legislation would curb the practice whereby brand-name drug companies prevent potential biosimilar and generic competitors from obtaining samples of the branded product, which are necessary to prove that the medicine is equivalent to the brand-name product, a prerequisite for Food and Drug Administration (FDA) approval. Under the legislation, a biosimilar or generic manufacturer would be permitted to seek injunctive relief in order to obtain the necessary sample when access to samples was blocked.

Second, lawmakers are looking to prevent brand-name drug companies whose products require a distribution safety protocol (known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or "REMS with ETASU") from refusing to allow biosimilar and generic competitors to participate in the safety protocol with the explicit intent to delay competition. According to the bill’s sponsors, the CREATES Act would allow the FDA more discretion to approve alternative safety protocols, rather than require the two parties to develop shared safety protocols.

The Senate bill is sponsored by Patrick Leahy (D., Vt.), and cosponsored by Chuck Grassley (R., Iowa); Mike Lee (R., Utah), chairman of the Judiciary Committee’s antitrust subcommittee; and Amy Klobuchar (D., Minn.) ranking member of the antitrust subcommittee. The identical House version (H.R. 965) was introduced by House Antitrust Subcommittee Chairman David N. Cicilline (D., R.I.) and Ranking Member Jim Sensenbrenner (R., Wis.). It is co-sponsored by House Judiciary Committee Chairman Jerrold Nadler (D., N.Y.), Ranking Member Doug Collins (R., Ga.), Peter Welch (D., Vt.), and Congressman David B. McKinley (R., W.V.). In the last Congress, the legislation failed to get out of committee.

"For too long, a few predatory name brand companies have used anticompetitive strategies to delay entry of lower cost generic drugs," said Leahy. "When these companies use unfair practices to keep drug prices artificially high, patients suffer ... Our bipartisan bill continues to gain momentum. It is precisely targeted to stop these abuses, and I’m committed to working on behalf of Vermonters in Congress to see that CREATES and other vital efforts to lower prescription drug prices are signed into law."

"This bipartisan bill will make it easier for generic drugs to enter the market, said Cicilline. "It will increase competition and help bring down prescription drug costs across the board. I’m pleased to be introducing it with Ranking Member Sensenbrenner today. I look forward to working with him as we pass this bill into law," he added.

The CREATES Act is strongly supported by the Association for Accessible Medicines (AAM), consumer groups including AARP, Consumers Union, and Public Citizen; the American College of Physicians; the American Hospital Association; the Campaign for Sustainable Rx Pricing; and America’s Health Insurance Plans (AHIP).

Senate Finance Committee hearings. Pharmaceutical companies are feeling pressure from other federal lawmakers to justify high drug prices. Senate Finance Committee Chairman Chuck Grassley (R., Iowa) and Ranking Member Ron Wyden (D., Ore.) have asked seven major pharmaceutical companies to testify before a committee hearing later this month about prescription drug costs. The companies invited include AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., Pfizer and Sanofi. Grassley noted that several of these companies initially declined the committee’s request to testify at a hearing last month.

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