WASHINGTON, D.C. – Rep. Earl L. “Buddy” Carter (R-GA) today introduced the Fairness in Orphan Drug Exclusivity Act, a bill to close a loophole that allows drug manufacturers to block new treatments options for rare diseases from coming to the market.
The Fairness in Orphan Drug Exclusivity Act amends the Orphan Drug Act of 1983 to require all drugs that obtain seven-years of market exclusivity to show that they have no reasonable expectation of recovering research and development costs through sales in the United States, thereby closing a loophole that allows manufacturers to obtain seven-year market exclusivity by “piggybacking” on the orphan drug status of an older drug.
“Patients shouldn’t suffer because of a technicality in a forty-year-old law,” said Rep. Carter. “This legislation reaffirms the original intention of the Orphan Drug Act of 1983, to encourage research and development, without the unintended consequence of new drugs being blocked from the market. Updating this bill is a common-sense measure to improve patients' health and limit bad actors from taking advantage of rare diseases to line their wallets.”
Read the full text of the legislation here.
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