Andrew Siddons
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 a bipartisan effort in the Senate Judiciary Committee still could face major industry opposition.
On Tuesday the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights reviewed a bill (S 3056) that would give generic drugmakers legal recourse when the makers of original drugs cite safety protocols to limit distributing samples of their products.
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 could limit 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 ensure drugs are being prescribed properly.
But according to Sen. Amy Klobuchar, D-Minn., the subcommittee’s ranking member and a co-sponsor of the bill, the FDA has received 100 complaints from generic drug makers that say 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, generic and brand-name manufacturers have to negotiate and share information about these programs. The generic drugmakers assert that negotiations are used to stall the introduction of potential competitors.
Antitrust laws might offer some recourse, but the bill’s sponsors say more specific legal language is needed. The bill was introduced last week by Grassley, Klobuchar, Sen. Mike Lee, R-Utah, the chairman 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 if companies behind the original product block the sale of their products. It would also allow companies to file suit if the originating drug company refuses to allow the generic drug maker to join the FDA-approved system of safe use.
Industry Opposition
The pharmaceutical industry is concerned about 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 of a brand-name drug.
The bill from Judiciary represents one of the few bipartisan legislative solutions that could address the debate over high drug prices. While the issue dominated congressional discourse last fall and earlier this year, it has largely faded into the background.
Leaders of the Senate’s Special Committee on Aging have also tried to address high drug prices by creating incentives for the generic drug market. Susan Collins, R-Maine, and Claire McCaskill, D-Mo., introduced a bill (S 2615) earlier this year that would reward companies that develop generic versions of older drugs that aren’t protected by patents but lack competition because their potential market is small. Collins plans to offer that bill as an amendment to a Senate biomedical research package intended to be a companion to the House-passed 21st Century Cures (HR 6) bill.
Congressional Democrats have also been pushing to get more generics on the market when a brand-name drug was developed with federal funding. The National Institutes of Health can exercise what are known as “march-in rights” to override drug patents when doing so would address unmet health and safety needs.
But the NIH seems reluctant to include expense as a reason to shorten the exclusive rights to sell a drug. On Monday, after considering a petition from consumer groups to allow generic competition for an expensive prostate cancer treatment developed with taxpayer dollars, the institute announced that it would not override the patent.
