Federal RuleAug 21
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DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-hr-843119th CongressWALLET
Prompt Approval of Safe Generic Drugs Act
Sponsored By: Representative Barragán, Nanette Diaz [D-CA-44]
Introduced
Summary
Allows FDA to approve certain generic drugs even when their labels omit safety details that are protected by another drug's patent or exclusivity. The agency must still include any safety information it determines is necessary to assure safe use.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Faster generic drug approvals with safety notes
If enacted, the FDA could approve some generic and follow-on drugs even if their labels omit certain safety details. This would only apply when those details are protected by market exclusivity or a patent. FDA could still require a safety notice on the label if needed to assure safe use. It would not change the scope of those exclusivity rights. This could bring some generics to market sooner and lower prices, but some labels might have fewer specifics unless FDA adds a notice.
Sponsors & CoSponsors
Sponsor
Barragán, Nanette Diaz [D-CA-44]
CA • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov