House Lawmakers Query Agencies About Spurring Drug Competition

By Dana A. Elfin

Lawmakers continued to focus on reining in rising drug prices July 27 as a House panel solicited ideas from the FDA and the FTC about how to remove roadblocks to pharmaceutical competition.

Food and Drug Administration Commissioner Scott M. Gottlieb and Federal Trade Commission official Markus Meier told members of the House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law about policies that could help curb certain regulatory abuses in the drug marketplace. Meier is acting director of the FTC’s Bureau of Competition.

The July 27 hearing, titled “Antitrust Concerns and the FDA Approval Process,” gave a lot of play to a possible legislative step, H.R. 2212, the “Creating and Restoring Equal Access to Equivalent Samples Act of 2017” (CREATES Act), to ease some of the competition roadblocks. There’s also a companion bill in the Senate.

The act would address situations where branded drug companies use FDA-required risk evaluation and mitigation strategies (REMS) to deny generic companies access to samples of branded drug products needed to conduct bioequivalence testing for generic approval.

The FDA sometimes requires a REMS plan from a drugmaker to ensure the benefits of the product outweigh its risks.

Penalty Authority

Subcommittee Chairman Tom Marino (R-Pa.) asked Gottlieb whether the FDA had ever exercised its current authority to levy civil monetary penalties against companies that abuse the REMS system. Gottlieb said the FDA had not levied any fines, adding the statutory authority was very complex and time-consuming with relatively modest penalties.

Gottlieb said there are things the FDA can do within its current authorities, but it can’t fully address some of the commercial restrictions that keep generic companies from getting access to samples. “We need to close loopholes that game rules and hurt consumers,” he said.

“It would seem to me that we could solve that problem if competitors with limited resources had access to the courts,” Marino said.

CREATES Act

The CREATES Act would create a cause of action in federal courts for a generic or biosimilar drug applicant to obtain sufficient samples to perform bioequivalency studies. The bill also would make it easier for a generic drug to get FDA approval for a separate REMS program. Marino is the chief House sponsor of the bill, while Sen. Patrick Leahy (D-Vt.) is the sponsor of the Senate version (S. 974).

Meier said the FTC supports the CREATES Act to stem REMS abuses. “The CREATES Act goes a very long way to try and resolve some of these issues,” he said,

The hearing is the fifth in a series convened by the committee on competition in the health-care marketplace.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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