BLOCKING Act of 2021
- Last Action
- 4/27/2021
Actions
- 2021-04-27Referred to the Subcommittee on Health.
- 2021-04-26Referred to the House Committee on Energy and Commerce.
- 2021-04-26Introduced in House
- 2021-04-26Introduced in House
CRS Summary
As of 2021-04-26 (00)
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
Subjects
- Competition and antitrust
- Drug safety, medical device, and laboratory regulation
- Health care costs and insurance
- Health care coverage and access
- Licensing and registrations
- Marketing and advertising
- Prescription drugs
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.