The so-called “cost recovery pathway” through which drug manufacturers can obtain seven years of patent exclusively for drugs that are profitable without patent protection artificially inflates the costs of life-saving drugs such as buprenorphine, a critical medication for medication-assisted treatment (MAT) for opioid use disorder. Ensuring that drug manufacturers cannot game the drug patent system will help lower treatment costs for patients and the healthcare system overall.
As there are currently no drugs that have orphan drug exclusivity under the cost recovery pathway, there’s no need for this legislation. The high-profile example of the FDA revoking buprenorphine’s orphan drug designation after Sen. Jeanne Shaheen (D-NH) and other lawmakers criticized the manufacturer for seeking orphan drug designation was likely enough to shame drug manufacturers into not abusing this loophole. Alternatively, it’s important to ensure that pharmaceutical manufacturers have appropriate monetary incentives for new drug development, and this legislation would endanger pharmaceutical profits and, by extension, new drug development.