Recently, the Federal Trade Commission (FTC) voted unanimously to launch an inquiry into pharmacy benefit managers (PBMs), with a specific focus on how these middlemen impact the ability of Patients to access and afford their medicines.

A new BioNJ infographic details the enormous influence that PBMs have on Patients – from failing to pass along rebates to reduce Patient out-of-pocket costs to worsened health outcomes due to treatment abandonment.

State Senator Ron Rice (LD-28), the longest-serving Black legislator in the State’s history, announced his intention to retire at the end of August following decades as a lawmaker at both State and local levels. Among numerous contributions, Senator Rice has left an indelible mark on New Jersey, particularly advancing civil and social justice throughout the State. BioNJ applauds and thanks the Senator for his years of service.

Summer will officially come to an end on September 15, which is when the Assembly Financial Institutions & Insurance (AFI), Health (AHE) and the Assembly Appropriations Committee (AAP) are expected to meet — with AFI and AHE expected to meet in the morning and AAP in the afternoon. Additionally, the Assembly Budget (ABU) and Human Services (AHU) committees are expected to meet on September 22.

While committee agendas have yet to be released, BioNJ expects several bills to be heard and will share once available. It is possible that more committees will ultimately meet on both days. BioNJ will update upon any relevant changes to the State Legislative calendar. 

The Small Business Innovation Research (SBIR) program — an important source of funding for innovation in the life sciences — is currently expected to be reauthorized in the National Defense Authorization Act (NDAA). This is anticipated to take place in late fall or early winter, which is several weeks after the program’s September 30 deadline. While it is expected to ultimately be reauthorized, several proposed reforms to the program would render it significantly less capable of amplifying innovation in the life sciences.

The Department of Defense (DoD), which administers nearly half of the entire SBIR budget, is expected to suspend the program until reauthorization. However, the National Institutes of Health (NIH) has suggested that its institutes will sustain SBIR under the assumption that it will ultimately be reauthorized later this year. SBIR may still be reauthorized prior to September 30, contingent upon deliberations in Congress.

Since 1990, entities in New Jersey have received over $426 million in SBIR funds through the NIH alone. These entities have been in every Congressional district throughout the State, and SBIR funding has resulted in:

• Nearly 200 patents
• 41 clinical trials
• Nearly 700 scientific publications

To date this year, New Jersey has received approximately $11 million thus far and is among the states that receive the highest amounts of funding annually.

Some of the motivations to reform SBIR are based on concerns that it can be abused by entities to receive excessive numbers of SBIR grants. One proposal to reform the program would limit eligibility based on the total number of awards received since the inception of the program. Another proposal would limit eligibility according to the number of awards an entity receives over a five-year period. Finally, another proposal would restrict eligibility based on more stringent commercialization benchmarks.

These modifications would be particularly problematic to innovation in the life sciences due to the amount of time and resources that R&D in the field demands.

Another motivation for the proposed reforms is that SBIR awards may be creating national security vulnerabilities due to the involvement of foreign entities in the work of some awardees. R&D in the life sciences benefits tremendously from international collaboration, and preventing entities who leverage this strength from receiving support through SBIR would severely inhibit innovation that produces life-saving treatments.

Accordingly, BioNJ will be engaging policymakers to convey not only the importance of reauthorization, but also the damaging effects that these proposed reforms would have on biomedical innovation.

On September 13th, CSBA, BIO, and Advamed will be co-hosting a special briefing on the importance of SBIR. To register, click here.

As is the case with SBIR, the FDA Prescription Drug User Fee Act (PDUFA) is also set to expire on September 30, 2022. PDUFA allows the FDA to collect fees from manufacturers to support the drug approval process. The agency is expected to lay off a substantial number of reviewers if Congress fails to reauthorize the program. The same timeframe affects the Biosimilar User Fee Act (BsUFA), Generic Drug User Fee Act (GDUFA) and Medical Device User Fee Amendments (MDUFA).

Reports indicate that FDA Commissioner Califf sent a memo to the agency articulating estimates that carryovers for PDUFA will sustain the program for about five weeks into the next fiscal year. This would suggest that the FDA has sufficient funds to sustain the program until about November 4 prior to staff having to depart.

Current versions of user fee reauthorization legislation from both legislative chambers remain significantly different, including distinctions in policies that would affect the regulation of in vitro diagnostic products, cybersecurity protections, cosmetics and diversity in clinical trials. The U.S. Senate is not expected to reconvene until September 6, and Senator Burr (R-NC), the Ranking Member of the Senate Health Committee, has introduced clean reauthorization language that would omit these regulatory reforms.

BioNJ has engaged in an educational campaign with policymakers to encourage timely renewal and will continue conveying the importance of this program to innovation in the life sciences in New Jersey.

For further information on PDUFA, click here. 

BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are still available for 2022. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.  

Click here for more information.