Legislation aimed at reducing the time it takes for new drugs to enter the market unanimously passed the Senate Health, Education, Labor and Pensions Committee on Wednesday along with bills addressing newborn opioid abuse and mental health.
The Improving Regulatory Transparency for New Medical Therapies Act — introduced by Sens. Orrin Hatch (R-Utah) and Sheldon Whitehouse (D-R.I.) — is designed to give drugmakers some certainty about how long their brand products will be on the market without generic competitors.
Data exclusivity rules bar competing drug makers from using original research to produce generic versions of a new drug for a period that typically varies between three and 15 years. Drug makers argue that exclusivity periods are necessary to offset research and development costs of new drugs.
Current law states that the exclusivity period begins when the Food and Drug Administration approves a new drug for use, even though drug makers are not allowed to market a new drug until the Department of Justice schedules it. Right now there is no time period for the Drug Enforcement Administration, the DOJ subdivision that handles the requests, to release the schedule.
The delay and uncertainty can cause problems and legal challenges. Last year, the drug company Eisai Inc. sued when the FDA would not increase the data exclusivity periods for two of its drugs that waited for DEA scheduling for a full year after they were approved. That lawsuit was still pending when the House passed its version of the bill this spring.
The Hatch/Whitehouse bill would start the exclusivity clock at the date of DEA scheduling rather than FDA approval. It would also set a 90-day time limit for the DEA to schedule new drugs after FDA approval. The bill’s lead sponsors say the time limit would allow new drugs to enter the market more quickly.
At the Senate markup on Wednesday, Whitehouse said the bill would address administrative problems within the DEA. “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.
The House passed its own version of the measure in March, and the HELP committee’s vote comes as politicians are facing pressure to address skyrocketing drug costs. Democratic presidential frontrunner Hillary Clinton recently unveiled her plan to reduce drug prices; her plan includes proposals to lower the exclusivity period for some specialty drugs from 15 to seven years and allow the government to negotiate prices with drug makers. The drug industry, not surprisingly, is unhappy with Clinton’s plan.
The HELP Committee also passed legislation Wednesday by Senate Majority Leader Mitch McConnell (R-Ky.) and Sen. Bob Casey (D-Pa.) addressing newborn exposure to opioids. The bill would require the Department of Health and Human Services to release a report evaluating the causes of prenatal opioid abuse. HHS would also identify and address gaps in research and programs addressing the issue.
The third bill — a collaboration between HELP Chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.) — focuses on suicide prevention. The legislation would reauthorize grants that go to mental health awareness training, push the Centers for Disease Control to modernize its National Violent Death Reporting System, and require the Government Accountability Office to examine mental health treatment options for children.
There is no timetable for a Senate floor vote on any of the measures.