A bill that closes a loophole allowing manufacturers to profit from the exclusive status of certain drugs that treat rare diseases or conditions passed the House of Representatives on Tuesday. H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, was introduced in October by Rep. Madeleine Dean (D-Penn.). The law is aimed at amending the Federal Food, Drug, and Cosmetic Act (FDCA) “with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.”
The bill seeks to end a presently exploitable loophole that permits manufacturers to abuse market exclusivity, rules which allot manufacturers who develop new treatments competition-free sales for a period of time. If passed into law, drugmakers will have to demonstrate more in order to obtain the same market exclusivity status for certain orphan drugs.
According to the text of the proposed law, the U.S. Food and Drug Administration (FDA) may only approve an exclusive license if there is “no reasonable expectation at the time of such approval or issuance that the cost of developing and making available in the United States such drug for such disease or condition would be recovered from sales in the United States of such drug, taking into account all sales made or reasonably expected to be made within 12 years of first marketing the drug.”
Health Subcommittee Chairwoman Anna G. Eshoo (D-Calif.) and Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-N.J.) released a statement after the bill and nine others passed the House, including a bill to support research into health disparities, to improve food and drug labeling, and a $10 million grant program for trauma centers that intervene in recurring violence situations.
Eshoo and Pallone stated that “[t]he House passed a broad range of health legislation today with strong bipartisan support.” They explained, “[t]he House also continued its bipartisan work to combat the opioid epidemic by providing $1.5 billion annually in grants to states and tribal organizations to support substance use disorder treatment and prevention, as well as new tools and authorities to prevent the illegal distribution of controlled substances. We commend members for their continued commitment to working together to pass legislation that improves the health and well-being of the American people and look forward to seeing these bills signed into law.”
Opioid lawsuits continue to create headlines as Law Street Media has recently reported. For example, state and local governments and Native American tribes have moved closer to securing settlements with opioid manufacturers like Johnson & Johnson. The Department of Justice also announced a settlement in its criminal and civil case against Purdue Pharma LP for opioid-related charges, while private litigation efforts remain ongoing.