Prompt Approval of Safe Generic Drugs Act
The Prompt Approval of Safe Generic Drugs Act would add a new provision to the Federal Food, Drug, and Cosmetic Act (FD&C Act) allowing certain drugs to be approved even if their labeling omits certain safety information. Specifically, if safety information is omitted due to protections such as exclusivity, patents, or extensions of exclusivity, a drug that has an application submitted or approved under NDA or ANDA could still be approved without being deemed ineligible or misbranded. The bill also requires that the labeling for such drugs include any appropriate safety information the FDA determines is necessary to ensure safe use. Importantly, the measure preserves existing exclusivity protections and does not alter the overall operation or basis for eligibility under other parts of the law. In short, the bill aims to speed the approval of safe generic drugs when certain safety details are blocked by IP protections, while ensuring that necessary safety information is still communicated to protect patients.
Key Points
- 1General rule: If safety information is omitted from labeling because it is protected by exclusivity, patents, or extensions, a drug approved or under application under NDA (b2) or ANDA (j) may not be disqualified or considered misbranded solely for that omission.
- 2Labeling requirement: For drugs approved under b2 or j with omitted safety information, the FDA must require labeling that includes any appropriate safety information the agency believes is necessary to assure safe use.
- 3Exclusivity scope preserved: The bill clarifies that this provision does not affect the availability or scope of exclusivity or extensions described in other parts of the statute, nor does it change eligibility for other applications that may omit other labeling aspects protected by exclusivity or patents.
- 4Limitations clarified: The operation of this new subsection and section 527 is not otherwise altered, except as expressly stated in the new rules for labeling and approval described in this addition.