After a Hiatus, the BLOCKING Act is Back!

We learned earlier this week that an allision (a runner-up to Merriam-Webster’s 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight (another runner-up to Merriam-Webster’s 2024 Word of the Year thanks to Taylor Swift)—as Congress considers various pieces of healthcare legislation as part of its year-end package.  As part of that package, we understand that discussions on the latest iteration of the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act” (“BLOCKING Act”) (also known as the “Expanding Access to Low-Cost Generics Act”) have resurfaced and could potentially hit the generic industry.  (Unless the legislative ship can be steered away.)

We’ve railed against passage of the BLOCKING Act since February 2018 when it was made as a legislative proposal in the first Trump Administration’s Proposed Fiscal Year 2019 Budget (pages 22 and 51)—including in blog posts (here, here, here, here, and here) and in Congressional testimony—as antithetical to a primary goal of the Hatch-Waxman Amendments: getting high quality, low-cost generic drugs into the hands of consumers—fast.  After all, the BLOCKING Act would significantly alter the ANDA Paragraph IV 180-day exclusivity incentive.  Specifically, it would further dilute the 180-day exclusivity incentive by amending the Paragraph IV 180-day exclusivity statutory provisions at FDC Act § 505(j)(5) to place new conditions on when a subsequent Paragraph IV ANDA can be approved notwithstanding a first applicant’s eligibility for 180-day exclusivity.

In our May 2023 B-B-B-B-Bad to the Bone post, we highlighted some changes to the original version of the BLOCKING Act, restyled as the Expanding Access to Low-Cost Generics Act of 2023, intended to guard against a subsequent Paragraph IV ANDA gutting the 180-day exclusivity incentive and that would somewhat blunt the negative effective of the legislation.  But we’ve made no bones about our take on BLOCKING and its progeny: “That being said, it’s kind of like putting lipstick on a pig.  In the end, the “Expanding Access to Low-Cost Generics Act of 2023” (S. 1114) is still the BLOCKING Act, and it is still bad to the bone.”

Based on what we’ve heard from the talk on Capitol Hill, the latest version of the BLOCKING Act that is poised for introduction in Congress within the next few days is the same language proposed for inclusion in the never-passed “Food and Drug Administration Safety and Landmark Advancements Act of 2022.”  That’s the version we dissected here, and that is available here.

Given that we’ve already covered the version of the BLOCKING Act apparently on tap for congressional consideration, we won’t do so again here.  But we thought a clarion call would be appropriate now.  After all, as we’ve said before—and it bears repeating over and over again—what generic drug companies would be willing to invest millions of dollars in generic drug development and patent challenges for the potential of a hollow exclusivity incentive?  More ANDA approvals does not necessarily translate into more launches.  Over time, a new exclusivity regime for Paragraph IV ANDAs may mean fewer ANDA approvals and launches.  And that ultimately means more drug shortages of critical medicines, fewer choices for consumers, and higher costs to the U.S. healthcare system.