FDA Commissioner, Scott Gottlieb, MD, testified before the House Judiciary Committee this afternoon in a hearing titled “Antitrust Concerns and the FDA Approval Process.”
FDA Commissioner, Scott Gottlieb, MD, testified before the House Judiciary Committee this afternoon in a hearing titled “Antitrust Concerns and the FDA Approval Process.”
Gottlieb opened his remarks by reiterating the FDA’s commitment to addressing the problem of high drug cost by encouraging competition, then itemized the steps the agency is taking to address barriers to competition in the pharmaceuticals marketplace:
Also testifying was Markus H. Meier, acting director of the FTC, who echoed Gottlieb’s concerns about REMS abuse, citizen petitions, and pay-for-delay arrangements. Yet, in comparison with Gottlieb’s measured approach to describing the difficulties facing the FDA, Meier took a bolder stance, saying “drug manufacturers have exploited certain features of the existing regulatory framework created by the Hatch-Waxman Act to extend exclusive rights well beyond the periods Congress provided to spur investments in innovation,” and calling REMS programs “an appropriate area for Congressional focus and concern.”
Meier echoed Gottlieb’s concerns about the use of REMS to delay generic entry, as well as refusal of testing samples to biosimilar and generics developers. Meier cited antitrust cases—including Celgene’s alleged use of REMS to prevent testing of its Thalomid and Revlimid, as well as Actelion’s alleged imposition of distribution restrictions to prevent competitors from accessing samples. Meier further indicated that the FTC has concerns about biosimilars manufacturers being denied information that would assist them in compliance with the Biologics Price Competition and Innovations Act (BPCIA).
Finally, Meier suggested that bipartisan House Bill 2212, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, could reduce incentives to abuse regulation. The act would, he said, allow generics firms to initiate legal action against innovator companies and obtain samples for testing after establishing that they had complied with existing statutes. It would also provide a clearer path for generics firms to establish separate REMS programs if necessary.
Additional testimony in support of the CREATES Act was provided by David Olson, Esq, associate professor of law at Boston College Law School, who said that the legislation is a “narrowly tailored solution to the failure to share samples.” Alden Abbott, Esq, deputy director of The Heritage Foundation, testified that the act addresses current statutory limitations, as current “antitrust laws are ill-suited to combat anticompetitive regulatory manipulation.” Erika Lietzan, Esq, associate professor of law at University of Missouri School of Law, testified that she had concerns about the CREATES Act, citing “weak empirical support for any legislative action” and saying that the act is “flatly inconsistent with fundamental patent law principles,” while Aaron Kesselheim, MD, MPH, associate professor of medicine at Harvard Medical School, praised the act, but called for additional, more extensive reform.
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