The State Legislature is expected to release its calendar soon, reconvening in the next few weeks in advance of the election on November 7. As a reminder: all 40 seats in the Senate and 80 seats in the Assembly will be up for a vote with a minimum of 32 seat changes, either by new members of the Legislature or members of the Assembly joining the Senate.

Last Tuesday, the Department of Health & Human Services (HHS) announced the first set of drugs that will be subject to the price negotiations provision of the Inflation Reduction Act (IRA). The list includes the following therapeutics:

• Eliquis
• Jardiance
• Xarelto
• Januvia
• Farxiga
• Entresto
• Enbrel
• Imbruvica
• Stelara
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

While several therapeutics that are included were previously anticipated to be subject to the IRA’s price-setting, the surprising inclusion of several of these therapeutics demonstrates the capricious capability of HHS to arbitrarily set prices. Additionally, the bundling of several insulin products — effectively extending beyond the expected 10 drugs subject to price setting — further demonstrates the expansive, opaque and unpredictable authorities and procedures that HHS will have moving forward. This aggressive interpretation of the IRA will exacerbate the ramifications that the legislation was already going to have if it were interpreted more stringently.

BioNJ will continue engaging the New Jersey congressional delegation to emphasize the need to address the particularly damaging provisions in the IRA and the critical need for these policy remedies. We released the following statement in response to this announcement by HHS:

The Centers for Medicare and Medicaid Services (CMS) will be holding Patient-focused listening sessions for each selected therapeutic for Patients and other interested parties. These sessions will be held between October 30 and November 15, though these are subject to postponement or cancellation.

For more information regarding CMS’s listening sessions, click here.

It is also worth noting that there are at least eight pending lawsuits that challenge a variety of IRA provisions.

As always, please contact Ian McLaughlin, VP of Government Affairs, with any thoughts or concerns: IMcLaughlin@BioNJ.org.

On September 12, BioNJ will join a coalition of organizations who will be visiting the offices of members of Congress in Washington, D.C. to advocate for the passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. Antimicrobial resistance (AMR) emerges as a byproduct of microbes, from bacteria and viruses to fungi and parasites, mutating by natural selection to evade the mechanisms that antimicrobials utilize to eliminate them. As a result, the antibiotics, antifungals and antiparasitic therapeutics on which healthcare systems rely are rendered ineffective.

AMR represents an existential threat to the capability of global healthcare systems to sustain an ability to confront the pathologies induced by microbes, and its emergence has been expedited by the prevalent use of antimicrobials in humans, livestock and agriculture. As of 2019, a study published in The Lancet, using susceptible infection, estimated that AMR may have represented a global cause of fatalities that rivals that of both HIV and malaria. Over 2.8 million antibiotic-resistant infections occur annually in the United States. However, the life sciences infrastructure devoted to the emergence of this public health challenge has remained essentially static for nearly 40 years.

The PASTEUR Act would form a committee devoted to the need of antimicrobials composed of representatives of federal agencies, physicians, Patients and scientists to articulate guidance regarding infections of concern. Most critically, it would establish a subscription model to incentivize the development of novel antimicrobials that will be delinked from federal health programs, such that manufacturers would not need to rely on reimbursement from health programs based on volume of sales.

For a section-by-section characterization of the PASTEUR Act, click here.

For more information on antimicrobial resistance and the merits of the PASTEUR Act, along with advocacy resources, 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 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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