By Andrew Siddons, CQ Roll Call
June 21, 2016 -- Lawmakers want to make it harder for brand-name pharmaceutical companies to use safety concerns as an excuse to block competition from generic drugmakers. But even a bipartisan effort in the Senate Judiciary Committee could face major obstacles.
On Tuesday the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights examined a bill (S 3056) that would give generic drugmakers legal recourse when the makers of original drugs cite safety protocols to limit distribution channels.
Generic drugmakers unable to obtain samples of the original treatment cannot determine whether their version is equivalent. That makes it harder to win approval from the Food and Drug Administration and limits competition that could help bring down drug prices.
Manufacturers of drugs with significant side effects or the potential for abuse have been required since 2007 to develop risk evaluation and mitigation strategies, programs designed to keep distribution channels secure and make sure drugs are being prescribed properly.
But according to Sen. Amy Klobuchar, D-Minn., the subcommittee’s ranking member and a cosponsor of the bill, the FDA has received 100 complaints from generic drug makers that they are being blocked from obtaining samples.
Judiciary Committee Chairman Charles E. Grassley, R-Iowa., said that using the risk evaluation programs as an excuse for blocking those sales was against FDA regulations – and against the law. “We also need to make sure that games aren’t being played and laws aren’t being undermined when we’re trying to increase the availability and affordability of prescription drugs,” he said.
When the safety protocols are required for a drug, brand-name and generic makers must negotiate and share information about these programs, but the generics industry asserts that talks are used to delay the introduction of potential competitors.
Antitrust laws might offer some recourse, but the bill’s sponsors believe more specific legal language is required. The bill was introduced last week by Grassley, Klobuchar, Sen. Mike Lee, R-Utah, chair of the subcommittee that held Tuesday’s hearing, and Sen. Patrick J. Leahy, D-Vt., the full committee’s ranking member.
The bill would allow generic drug companies to bring civil suits against the company behind the original product if that company was denying sale of the original drug to the generic maker. It would also allow companies to file suit if the original drug company refuses to allow the generic drug maker to join the FDA-approved system of safe use.
The pharmaceutical industry worries that the legislation could have unintended consequences. “While we are currently reviewing the legislation, we would be concerned if patient safety could be jeopardized in any way,” the Pharmaceutical Research and Manufacturers of America said in a statement.
At Tuesday’s hearing, Peter O. Safir, senior council at the law firm Convington & Burling, noted that the bill could discourage generic drugmakers from negotiating in good faith over the risk evaluation strategies. He said that it also might encourage them to file suit years before the expiration of a patent.