Fairness in Orphan Drug Exclusivity Act

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 specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

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.

Bill 117 HR 1629, also known as the Fairness in Orphan Drug Exclusivity Act, is a piece of legislation currently being considered by the US Congress. The purpose of this bill is to address concerns regarding the exclusivity period granted to orphan drugs, which are medications developed to treat rare diseases.

Under current law, pharmaceutical companies that develop orphan drugs are granted a period of exclusivity, during which no generic versions of the drug can be produced. This exclusivity period is intended to incentivize companies to invest in the development of drugs for rare diseases, which may not be as profitable as drugs for more common conditions.

However, some critics argue that the current system allows pharmaceutical companies to extend their exclusivity period by making minor changes to the drug, known as "evergreening." This practice can prevent generic versions of the drug from entering the market, leading to higher prices and limited access for patients. The Fairness in Orphan Drug Exclusivity Act aims to address these concerns by implementing stricter criteria for extending exclusivity periods for orphan drugs. The bill would require companies to demonstrate that any changes made to the drug are necessary for the treatment of the rare disease and do not simply serve to prolong exclusivity. Overall, the Fairness in Orphan Drug Exclusivity Act seeks to strike a balance between incentivizing innovation in the development of orphan drugs and ensuring that patients have access to affordable medications. The bill is currently under review in Congress, where lawmakers will consider its potential impact on the pharmaceutical industry and patients with rare diseases.