The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the Court continues to recognize that under certain circumstances such conduct may violate the Sherman Act.[1] Additionally, complaints to the Federal Trade Commission (FTC) alleging violation of antitrust laws, have resulted in past investigations. Both the Food and Drug Administration (FDA) and FTC are active in both enforcement and advocacy surrounding restricted distribution system abuses.
Background
In clinical trials, a comparator drug is often required. Such studies are on the rise because of intense market competition, pressure from payers and the rise of co-therapies, especially in the therapeutic area of HIV and oncology, clearly some of the most vulnerable patient populations. Government agencies even sponsor research on comparative effectiveness. Besides the increased demand that the clinical trial industry have observed, there are decreasing supply, increased cost, and access problems which are now disrupting clinical research for FDA approval and even the best up front planning. Access problems in obtaining comparator products are causing significant delays and increased study cycle times. A great deal of planning is required to ensure availability of the quantity of drug required and when comparator drugs are suddenly unavailable, patients enrolled in clinical trials are harmed.
Applicable Laws
CREATES Act
Section 610 of the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act)[2], which was prompted by allegations that reference product manufacturers were delaying generic/biosimilar competition by refusing to provide reference product supply to generic and biosimilar drug developers, addressed the issue of access to product samples. The CREATES Act specifically, addressed access to specific quantities for testing to support an application under 505(b)(2) or 505(j) or 351(k) and for fulfillment of any requests relating to approval of such applications. Covered products include drugs, biologics, generic drugs, biosimilar, and any combination of a drug or biologic product. The CREATES Act provides a private right of action to obtain sufficient quantities of reference product from the product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products. Private litigants (i.e. generic drug manufacturers), have sued reference product manufacturers under antitrust clauses of action alleging such conduct is anticompetitive.
A 505(b)(2) application is a type of New Drug Application (NDA) that contains full reports of investigations of safety and effectiveness, where at least some of the information comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use. A 505(b)(2) application is a hybrid between a full NDA (505(b)(1)) and an Abbreviated New Drug Application (ANDA). Some research by sponsors seeking new indications clearly pertains to 505(b)(2) applications. Other research pertains to development of biosimilars. This falls squarely within the CREATES Act.
How Frier Levitt Can Help
Frier Levitt offers a full range of Government Affairs/Advocacy services to assist and counsel wholesalers, drug distributors and pharmacies on various regulations set forth by federal and state agencies. We can help you navigate FDA and FTC guidelines or if you have general questions concerning regulation of comparator drugs, contact us today to speak with an attorney.
[1] 15 U.S.C. §1; 15 U.S.C. §2.
[2] Further Consolidated Appropriations Act, December 20, 209, Sec 610, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017.
