Orphan drugs 7 years market exclusive rights loophole is about to be filled?

The 〡's Orphan Medicine Act of 1983 aims to reward pharmaceutical companies for developing drugs to treat rare diseases.
, criticism of the bill's abuse has been growing over the years.
, a new bill is a first step toward closing loopholes.
November 18, 2020, the U.S. House of Representatives unanimously passed a bill requiring drugmakers to prove that they do not expect to recover research and development costs from domestic sales within 12 years if they want to gain seven-year market exclusive rights for orphan drugs.
Representative Madeleine Dean, Democrat of Pennsylvania, said the bill fills a loophole in the pharmaceutical commercial market for the title of orphan drug.
Dean is the co-founder of The Fairness of orphan drug franchises.
If a drug is intended to treat a disease that affects less than 200,000 patients in the United States, or, in a less common case, if the developer does not want to recover development costs from the sale of the drug, the FDA can grant the drug seven years of market exclusive control.
, however, for the second approach, the current law allows for an extension of market exclusive rights to a new version of the same drug without the need for drugmakers to show renewed profitability, a loophole that the new law is designed to fill.
the whole operation stems from Indivior's butyl nophrine controversy (treatment of opioid addiction).
in 1994, before the opioid abuse crisis, the drug was first FDA-approved under the Subutex brand and gained seven years of market exclusive control.
2016, a new injection form called Sublocade was approved and granted a seven-year privilege.
the end of 2019, the FDA had to withdraw its original orphan designation to allow other butyl nophrine generics to enter the market, on the grounds that Indivior had made billions of dollars from the drug.
but loopholes in the law remain.
The House bill gives drugmakers 60 days to prove that it did not reasonably expect to recover research and development costs within 12 years of the drug's initial market launch.
without this certification, the FDA would revoke its exclusive rights.
from the designation of orphan drugs to final approval, it usually takes several years.
industry and the public often denounce the same drug's use of orphan drug laws for continued market access.
This is primarily a matter of listing drugs before the FDA's new rules in 2017, which prevent the continuous exodivity of the same drug unless the drugmaker can prove that the new drug is clinically superior to the previously approved version.
Eagle Pharmaceuticals took advantage of a similar loophole, with the blood cancer drug Treanda and its new sister drug, Bendka, based on the same active ingredient, Bendamostin.
late 2015, just as Treanda's exclusive rights to orphan drugs were expiring, Bendeka received FDA approval.
When Eagle sought a seven-year exclusive right for Bendeka, the FDA tried to block it by invoking the "clinical advantage" rule, but the "clinical advantage" element of the 2017 FDA reauthorized act was filed by Eagle, which took effect after Bendeka's approval, and the court ruled against the FDA.
because Bendka and Treanda are essentially the same drug, granting Bendka a seven-year exclusive right effectively delays the launch of all Bendamostin generics until the end of 2022.
the FDA estimates that at least 11 pre-2017 drugs have been stripped of their orphan exclusive effects because of "clinical advantage" rules, but in the case of Bendeka, the drugs could be profitable.