Both the FDA User Fee and the Small Business Innovation Research (SBIR) programs were reauthorized on September 30. While both programs avoided some of the significant alterations that had been proposed, PDUFA VII contains a few new pilot programs to accelerate reviews.

The Split Real Time Application Review (STAR pilot program) will accelerate FDA reviews of efficacy supplements across therapeutic areas via earlier data submission for submissions that propose to address an unmet medical need, comparable to the Oncology Center of Excellence’s expedited Real Time Oncology Review Program (RTOR). STAR applications will be able to submit top-line results that indicate a drug is resulting in improvements on clinically relevant endpoints relative to available therapies.

Additionally, CDER and CBER are collaborating on the Rare Disease Endpoint Advancement (RDEA) pilot to provide for additional meetings between the FDA and sponsors. Starting in July 2023, sponsors will be able to submit RDEA proposals, from which FDA will select one in the first year — followed by the selection of one per quarter in FY 2024 to 2027, with a maximum of three per year. FDA will conduct initial meetings and up to three follow-up meetings and respond to proposals within 60 days following the end of the fiscal year quarter during which proposals are submitted.

A publication in Fordham Intellectual Property, Media & Entertainment Law Journal, entitled "Solutions Still Searching for a Problem: A Call for Relevant Data to Support 'Evergreening' Allegations," was published on September 26. The research evaluates the data that are used to substantiate claims that manufacturers exploit patent law to achieve excessive periods of exclusivity, providing a database of patents and exclusivities hosted by the University of California Hastings College of Law.

The group audited over 200 entries, each of which having a generic drug commercially available prior to their inclusion in the database, demonstrating that generic competition launched significantly earlier than the latest expiration date of various protections applicable to new drug applications. As a result, the group suggests that the latest expiration date of protections is not the most critical data point when trying to ensure timely generic competition. Legislation devised prior to the demonstration of data that support the underlying legislation would be premature.

Both the State Assembly and Senate have met several times since BioNJ’s most recent Public Policy Update, and while several relevant committees have met — including the Senate Budget and Appropriations Committee, the package of legislation targeting prescription drugs has yet to be heard or recommitted. The Assembly Appropriations Committee, to which most of the package is currently referred in the lower House, has yet to meet since the Legislature reconvened after the summer. BioNJ continues to engage the Legislature regarding concerns with some of the provisions in the legislation and will update upon any new developments.

Other legislation worth noting:

A515 (Freiman) / S3126 (Testa/Greenstein) - Provides temporary corporation business tax and gross income tax credits for insourcing business to New Jersey.

A2014 (Conaway/Wirths/Umba) / S659 (Oroho/Greenstein) - "Manufacturing in Higher Education Act"; requires various State entities to promote manufacturing career pathways for students and provides assistance to manufacturing industry.

• This bill passed the Senate unanimously and moved through the Assembly Higher Education Committee (AHI) on October 13.

A3523 (Benson/Stanley/Conaway) / S2305 (Gopal/Greenstein) - Requires health insurers to cover colorectal cancer screenings recommended by United States Preventive Services Task Force and eliminates cost-sharing requirements for certain colonoscopies.

• This bill was reported by both the Assembly Financial Institutions and Insurance Committee (AFI) and the Senate Budget and Appropriations Committee (SBA) on October 13.

The World Health Organization (WHO) Intergovernmental Negotiating Body convened, and the role of intellectual property was debated. Similar disagreements that have been raised in the past were heard, including an emphasis of the lack of evidence that IP protections have stymied Patient access to diagnostics, therapeutics and vaccines. While deliberations at the WHO continue in the run-up to the decision in mid-December, the Biden administration has yet to signal what its position will be.

BioNJ will continue to engage the New Jersey Congressional delegation to highlight the importance of IP protections to innovation — as well as the significant ramifications that expanding the waiver would have — among life sciences organizations throughout New Jersey and beyond.

On October 14, President Biden issued an Executive Order to direct the Department of Health and Human Services to submit a formal report within 90 days that outlines plans to use the Innovation Center’s authority to lower drug costs and promote Patient access for Medicare beneficiaries. The Innovation Center, housed within CMS, is devoted to exploring new healthcare payment and service delivery models via alternative payment models. BioNJ will update upon any further developments or announcements.

BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are now available for 2023. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.  

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