Legislation ensuring drugmakers can sell their products without competition for the full duration of their exclusivity period passed a Senate committee on Wednesday.
Called the Improving Regulatory Transparency for New Medical Therapies Act, the bipartisan bill from Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., was approved unanimously by the Health, Education, Labor and Pensions Committee and next goes before the full Senate.
Lawmakers say the bill solves a problem experienced by pharmaceutical companies that are granted a period, usually ranging from three to 15 years, during which they’re allowed to sell their products without competition from generics. The period of exclusivity starts when the Food and Drug Administration approves a drug, even though the company can’t start marketing it until the Drug Enforcement Administration gives the green light.
That means some drugmakers must wait to market their drug, sometimes for months, even though the clock has started ticking on their period of exclusivity. Last year, drugmaker Eisai sued the FDA after having to wait a full year before it received DEA approval.
The Hatch-Whitehouse bill would start the exclusivity clock when the DEA gives the go-head, instead of when the FDA approves it.
“It was with some discouragement that I came to Washington and have repeatedly seen difficulties with DEA in its administrative world, and I’m very glad the new DEA administrator appears to be paying attention to this,” Whitehouse said at the hearing.
The House passed a version of the legislation in the spring, but it could run into some opposition as lawmakers face the problem of increasingly high drug costs. Some policymakers have proposed reducing exclusivity periods as a way of introducing more competition and lowering prices.
