Pair of ex-HHS counsels criticize bill to 'upend' 180-day exclusivity for first generic drugs
Three years ago, a pair of bipartisan congressmen introduced legislation called the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics,” or BLOCKING Act — claiming to try and keep drug prices down by increasing competition among generic drug makers.
Kurt SchraderAnd while trade organizations like the generic-focused Association for Accessible Medicines sent a letter to then-President Trump expressing their opposition to that act, two high-ranking ex-government officials are speaking out against it — and explaining why it might not help.
Margaret Dotzel and William Schultz co-authored a report earlier this month about the proposed BLOCKING Act, saying in short that instead of, as bill co-sponsor Congressman Kurt Schrader (D-OR) said it would stop generic drug “parking” and mirror a proposal to “speed development of more affordable generics to spur competition,” it would instead do the opposite.
The bill was originally written to provide a workaround to generic drug “parking,” the practice where companies who are the first to get to the FDA with a generic candidate, pause at the tentative approval stage. In short, the bill would allow the FDA to approve generic drugs from rival competitors who were not the first before the agency if certain conditions were met. These would include:
- A subsequent Paragraph IV ANDA is ready for final approval but for a first applicant’s eligibility for 180- day exclusivity;
- At least 30 months have passed since the first applicant submitted its ANDA to FDA;
- The 30-month patent litigation stay of ANDA approval invoked when patent infringement litigation is timely initiated does not preclude approval of a first applicant’s ANDA; and
- FDA has not approved a first applicant’s ANDA as of the date the first three requirements above are met.
Dotzel and Schultz are attorneys with the nationally-recognized law firm Zuckerman Spaeder, but Schultz previously served as general counsel at HHS and as the deputy commissioner for policy at the FDA. Dotzel was the acting general counsel and deputy general counsel at HHS and the associate commissioner for policy while at the FDA.
In the 11-page report titled “An Evidence-based Assessment of the BLOCKING Act,” the pair dove into case studies of drugs that under the BLOCKING Act would not have accelerated generic entry and patient access due to a variety of factors. The drugs that the attorneys dove into included Xifaxan, Revlimid, Cialis, Rytary and Belbuca buccal film — and in all but one of those cases (Belbuca), the attorneys argued that the generic entry and patient access would not have accelerated under BLOCKING because “the subsequent applicant will not launch upon approval due to a patent settlement.”
Further, they went after a series of assumptions that they argue were pivotal to how the legislation was written. The primary ones were that, from their view:
- “There is an assumption that, for its part, FDA ordinarily approves a first applicant’s ANDA within 30 months of submission”
- “There is an assumption that a subsequent applicant will legally be able to begin marketing its drug product once FDA approval is secured.”
According to the attorneys, those are incorrect, pointing to data that showed that the mean and median FDA review times for Paragraph IV ANDAs were over 4 years — 51 months at the median and 57 months on average.
Dotzel and Schultz also added, “Subsequent applicants frequently sign on to the same baseline patent settlement with either the same or a later launch date as the first applicant. That means that subsequent applicants will be legally precluded from launching, notwithstanding an ANDA approval granted by BLOCKING.”
In summary, the Act, according to Dotzel and Schultz:
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.
