Over the past few years, this blogger – in prior blog posts (here, here, here, and here) and in Congressional testimony – has been pretty critical of efforts to significantly revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 Hatch-Waxman Amendments and amended with the passage of the 2003 Medicare Modernization Act. That effort, which has most recently emerged in the forms of the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021” (H.R. 2853, or “BLOCKING Act”), the “Expanding Access to Low-Cost Generics Act of 2021” (S. 2910), and in President Biden’s Fiscal Year 2023 Budget Request, is antithetical to a primary goal of the Hatch-Waxman Amendments: getting high quality, low-cost generic drugs into the hands of consumers—fast. And now there’s a report and analysis to back up that claim!
In a new report, titled “An Evidence-Based Assessment Of The BLOCKING Act,” co-authors William B. Schultz and Margaret M. Dotzel assess whether the stated goal of the BLOCKING Act – i.e., accelerating generic drug market entry – would actually be achieved. And their conclusion is:
The BLOCKING Act, if passed, will not accelerate generic drug entry. Instead, it will upend the critical 180-day exclusivity incentive by making it far less predictable and therefore far less valuable. As a result, fewer generic drug manufacturers are likely to make the significant investment needed to challenge patent estates on expensive brand-name drugs, even when those challenges could have been successful or resulted in favorable settlements. The net effect will be that brand-name prices will remain higher for longer, and there will be fewer generic drugs available to patients.
We couldn’t have said it any better than Mr. Schultz, who previously served as the General Counsel at the U.S. Department of Health and Human Services and the Deputy Commissioner for Policy at FDA, and Ms. Dotzel, who previously served as the Acting General Counsel and Deputy General Counsel at the U.S. Department of Health and Human Services and the Associate Commissioner for Policy at FDA. And although the BLOCKING Act was not the topic at hand – though definitely an undercurrent – we note that the conclusion that “there will be fewer generic drugs available to patients” was the topic of a segment on 60 Minutes earlier this week, titled “Life-saving generic drugs with low profit margins getting harder to procure.” After all, 180-day exclusivity has helped some companies stay in the market for unprofitable – but important – drugs. But as the 180-day exclusivity incentive has become diluted, and if it is even more unpredictable as a result of the BLOCKING Act, more companies will leave the market or discontinue manufacture of products, exacerbating the drug shortage problem.
The new action-packed and data-driven report has three primary sections. Section I provides data demonstrating the importance of the 180-day exclusivity incentive to generic competition. Section II picks apart the issues that BLOCKING Act proponents claim justify the legislation (and why those claims are often overstated). Section III explains the BLOCKING Act’s mechanics and why the legislation will not work to achieve its goal of accelerating generic competition. In particular, Mr. Schultz and Ms. Dotzel imagine a world in which BLOCKING is the law (gulp!) and apply the legislation’s mechanics to five cases alleged to be instances that the BLOCKING Act is intended to address:
- Case Study 1: Xifaxan® (rifaximin) Tablets, 550 mg
- Case Study 2: Revlimid® (lenalidomide) Capsules
- Case Study 3: Cialis® (tadalafil) Tablets
- Case Study 4: Rytary® (carpidopa/levodopa) Extended-release Capsules
- Case Study 5: Belbuca® (buprenorphine) Buccal Film
In each case study, Mr. Schultz and Ms. Dotzel methodically show that application of the BLOCKING Act would have resulted in the same outcome: generic drug entry and patient access would not accelerate! That’s pretty powerful and compelling stuff! And hopefully something that Congress will take note of as it considers what pieces of legislation should ultimately be included in the 2022 User Fee Amendments legislation currently being worked on.
As things stand right now, neither H.R. 7667, the “Food and Drug Amendments of 2022,” nor the Senate’s “FDASLA” (i.e., the “FDA Safety and Landmark Advancements Act of 2022”) include the BLOCKING Act. But there’s still quite a ways to go to get to the finish line for the UFA legislation. This is no time for the generic drug industry to let down its guard. And don’t forget about FDA’s proposed 180-day exclusivity rework included in the Agency’s Fiscal Year 2023 Budget Justification Legislative Proposals. We most definitely haven’t forgotten about that as you’ll soon read. . . .[FDA]