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Fairness in Orphan Drug Exclusivity Act
12/15/2023, 3:53 PM
Summary of Bill HR 456
However, there have been instances where companies have received multiple orphan drug designations for the same drug, allowing them to extend their exclusivity period beyond the intended seven years. This has raised concerns about the abuse of the orphan drug designation system and the potential for companies to exploit loopholes to maintain their monopoly on a drug for longer than necessary.
The Fairness in Orphan Drug Exclusivity Act seeks to address these issues by implementing stricter criteria for obtaining multiple orphan drug designations for the same drug. It aims to ensure that companies are not able to unfairly extend their exclusivity period and that patients have access to affordable medications in a timely manner. Overall, the bill aims to promote fairness and transparency in the orphan drug designation process, while still incentivizing pharmaceutical companies to develop treatments for rare diseases. It is an important step towards ensuring that patients with rare diseases have access to the medications they need, without being subject to excessive pricing or delays in availability.
Congressional Summary of HR 456
Fairness in Orphan Drug Exclusivity Act
This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)
Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug.
When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
