Should Congress Pass the BLOCKING Act of 2021?
In April of 2021, a bill was introduced to the House of Representatives called the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 (or simply, the BLOCKING Act). This bill, if passed into law, would remove the 180-day exclusivity period for new generic drugs. While the intent is to expedite more generic drug entries to the market, some experts fear it may have the opposite effect by disincentivizing generic manufacturers to enter the space in the first place.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to the first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon the 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.
What do you think? Would the BLOCKING Act be good for pharmacies and patients? Would it lead to more generics on the market sooner? Or, would it discourage manufacturers by removing the incentive of market exclusivity?
**Earlier this year we polled our audience to find out what they thought. The results can be found below.