WASHINGTON, DC – Today, the Energy and Commerce’s subcommittee on Health held a hearing on improving safety and transparency in America’s Food and Drugs where they discussed multiple health and good government bills, including the Fairness in Orphan Drug Exclusivity Act (H.R. 4712).

This bipartisan legislation was introduced last October by Reps. Madeleine Dean (PA-04), Marc Veasey (TX-33), Earl L. “Buddy” Carter (GA-01), and David McKinley (WV-01). H.R. 4712 seeks to close a loophole that blocks pharmaceutical competition and prevents innovative treatments for needed health problems like opioid use disorder from coming to market.

“The opioid epidemic touches all families and we must look at unique solutions to fully deal with this public health care crisis,” Rep. Dean said. “This bipartisan legislation would expand treatment options for patients – I thank the Energy and Commerce for their leadership and for considering this legislation, and I look forward to continuing to work on this and other solutions to combat the scourge of addiction.”

“I am honored that the Energy and Commerce Committee held this important hearing today on legislation I co-sponsored to help curb our nation’s opioid epidemic,” Congressman Veasey said. “This legislation is a much-needed step forward because it will create more treatment options and drive down the cost of life-saving medicines.”
The Fairness in Orphan Drug Exclusivity Act would close a loophole that blocks new therapies from coming to the market. Closing this loophole would aid in mitigating the opioid crisis by making a minor update to the Orphan Drug Act – requiring all drugs that obtain seven years of market exclusivity under the second criterion to show that they have no reasonable expectation of recovering R&D costs through sales in the United States.

“Competition is key to driving down the costs of prescription drugs and giving doctors and patients more options for treatment. The Orphan Drug Act was not intended to block competition for drugs that address common diseases,” Rep. McKinley said. “With millions of Americans struggling with addiction, opioid dependence has sadly become more common. This reform is a common sense step to help people struggling with addiction and I am pleased to see Energy and Commerce considering this important legislation.”

The Energy and Commerce's subcommittee on Health’s witnesses underscored the need for H.R. 4712. The Fairness in Orphan Drug Exclusivity Act is supported by AIDS United, Aimed Alliance, Young People in Recovery, No More ODs – The Savannah Harm Reduction Coalition, and A Mother’s Addiction Journey.

Rep. Madeleine Dean is a mother, grandmother, attorney, professor, former four-term member of the Pennsylvania House of Representatives, member of the Freshman Working Group on Addiction, and U.S. Representative for the Fourth District of Pennsylvania.