Should Congress limit the FDA’s use of “Orphan Drug Status”?

This bill has Passed the House of Representatives
Bill Summary

This bill limits which drugs can be granted an “orphan drug status” by the Food and Drug Administration (FDA). The Orphan Drug status gives exclusive rights to a manufacturer to sell a drug. Currently, manufacturers must show that (1) fewer than 200,000 people in the United States will receive the drug or (2) that there is no feasible way for the manufacturer to make back the cost of producing and distributing the drug. If either of these provisions is met, the Orphan Drug Status can be granted for up to seven years. Under H.R. 1629, pharmaceutical companies will have to meet both criteria. H.R. 1629 also carves out an exception to the first criteria for treatments that affect opioid use disorder, meaning that such treatments will not have to affect fewer than 200,000 people to qualify for Orphan Drug Status. Sponsor: Rep. Madeleine Dean (Democrat, Pennsylvania, District 4) View full bill text ➔

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Opponents say

• "It is true that these drugs command a high price. The rationale is that even at a high price, these drugs can save the healthcare system significant money. If an untreated rare disease costs the healthcare system $200,000/patient/year, and a new drug for this disease not only ameliorates the disease but also reduces other associated healthcare costs, a price of $100,000/patient/year can be a bargain – as well as help the patient." Source: John LaMattina (Former President of Pfizer Global Research and Development)

Proponents say

• "The Fairness in Orphan Drug Exclusivity Act will eliminate barriers for innovative medication-assisted treatments (MAT) to come to market, boost competition in the marketplace, and drive down the cost of new medicines." Source: Rep. Madeleine Dean (Democrat, Pennsylvania, District 4)

• "Congress needs to do everything in its power to curb skyrocketing prescription prices, and that includes cracking down on drug manufacturers who abuse the system to prevent more affordable competitors from coming to market,” said Shaheen. “As our communities fight to turn the tide of the substance use disorder epidemic, we need to be doing everything we can to ensure patients and treatment providers have access to affordable, effective medication to respond to this crisis." Source: Sen. Jeanne Shaheen (Democrat, New Hampshire)