The FTC Sides with Generics on Innovator Sample Drug Availability

In a recent case in the United States District Court for the District of New Jersey, the Federal Trade Commission (FTC) has sided with generic manufacturers regarding access to samples of medicines from innovator drug companies by filing an amicus (or Friend-of-the-Court) brief. The original lawsuit, filed by an innovator drug company, seeks declaratory relief that it is under no duty to supply prospective Abbreviated New Drug Application applicants with its brand name drug products for the purposes of bioequivalence testing and ANDA submissions.

The FTC argues in its brief that innovator drug manufacturers that withhold samples from generic drugmakers are stifling competition. The brand company, in this preemptive lawsuit, has alleged that its generic drug competitors sent threatening letters asserting that the brand name drug manufacturer was obligated to provide samples. The innovator further alleged that it is prevented from providing samples under Risk Evaluation and Mitigation Strategy (REMS) stipulations, which relate, in very general terms, to specific plans to help mitigate potential risks asserted with the use of a particular drug.

The FTC argued that the Hatch-Waxman Act, which provides, among other things, the generic drug approval pathway, would be undermined if generic drugmakers are unable to access samples of brand products. The FTC further noted that an innovator’s refusal to sell to its potential competitors may, under certain circumstances, violate the antitrust laws. This type of exclusionary conduct could violate Section 1 and Section 2 of the Sherman Act.

This isn’t the first time the FTC has jumped into the innovator-generic drug company competition fray. The FTC has become very aggressive in challenging pharmaceutical industry settlements of patent infringement litigation under the Hatch-Waxman Act. The settlement agreement provisions that have been subject to these lawsuits are referred to as “reverse payments” or “pay for delay” agreements. The federal courts are split their opinions on the legality of these agreements, and this issue is currently before the United States Supreme Court.

This most recent filing by the FTC is significant, because it is indicative of the careful scrutiny the agency undertakes in its Hatch-Waxman enforcement and its apparent preferences to protect generic drug market entry. This is also consistent with the current Department of Justice’s enforcement in this area. See Department of Justice amicus curiae filing in Schering-Plough Corp. (2005)

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