November 13, 2019

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Keep your finger on the pulse of the most critical issues facing the industry, our Members and Patients with BioNJ's bi-weekly Public Policy Update . Because Patients Can't Wait ®

FEDERAL

Drug Pricing Update: House Vote Delayed Again A U.S. House vote on H.R. 3 has again been delayed. The vote slated for October and then mid-November has been moved back until after Thanksgiving while Congress awaits the Congressional Budget Office’s score of the legislation. A preliminary score of the legislation estimated that not only would H.R. 3 result in fewer new therapies for Patients, but would also cause significant employment disruptions in New Jersey and other states with strong life sciences sectors. One estimate shows that the legislation would cost New Jerseyans more than 54,000 jobs, reduce statewide economic activity by $15 billion, and – most importantly – reduce Patient access to necessary and lifesaving treatments. BioNJ believes there is a right way and wrong way to address drug costs, and H.R. 3 misses the mark on addressing the price Patients pay at the pharmacy counter. We look forward to working with our delegation moving forward to enact common-sense legislation that reduces Patient costs and protects medical innovation.

BioNJ Submits Comments on IRS Section 382 Proposal  BioNJ has submitted comments to the Internal Revenue Service (IRS) on the agency’s plan to eliminate the “Section 338” approach that has been allowed via Section 382. The IRS has allowed for the Section 338 approach in guidance for more than 15 years. This approach has been a benefit to organizations that spend significant up-front amounts in areas such as research under the concept that research is an asset that might generate future revenue. In the agency’s September 10 proposed rule , IRS proposed to eliminate this approach to net operating losses (NOL). BioNJ urges the IRS to reverse course on this regulation and preserve the Section 338 approach status quo and continue supporting tax policies that preserve investment in the life sciences and other high-tech industries.

Click here for a copy of BioNJ's comments

Trump Nominates Stephen Hahn to Lead FDA  President Trump has nominated Dr. Stephen Hahn to become the next Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Hahn would replace former Commissioner Scott Gottlieb, who left the agency earlier this year. Dr. Hahn is a radiation oncologist and chief medical executive at the University of Texas MD Anderson Cancer Center, and he had previously led the radiation oncology department at the University of Pennsylvania’s Perelman School of Medicine. Brett Giroir, the current Assistant Secretary for Health at the U.S. Department of Health and Human Services, will serve as interim commissioner until the U.S. Senate considers Dr. Hahn’s nomination.

STATE

Election Update November 5 was election day in New Jersey, with elections for the General Assembly atop the ticket. All 80 General Assembly seats were on the ballot along with a number of statewide referendums and a special election for a South Jersey State Senate seat. Incumbents held seats for the most part throughout the Garden State. Exceptions were mainly based in New Jersey’s 1 st legislative district encompassing parts of Atlantic, Cape May and Cumberland Countries. All three incumbents in LD-1 – State Sen. Bob Andrzejczak and Assemblymen Bruce Land and Matthew Milam – lost to Republican challengers Mike Testa, Erik Simonsen and Antwan McClellan, respectively. Andrzejczak had been appointed to the New Jersey State Senate seat previously held by U.S. Rep. Jeff Van Drew when he was elected to Congress. The New Jersey Legislature convened for its lame duck session November 7 with several meeting dates on the calendar until the mid-January beginning of the next legislative session.  BioNJ congratulates all new and returning members of the New Jersey General Assembly, and we look forward to working with the New Jersey Legislature on behalf of both Patients and the New Jersey life sciences sector.

THIS FRIDAY: BioNJ, Caregivers of NJ Team Up for Caregivers Event Join BioNJ and the Caregivers of NJ for an event commemorating National Caregivers month. The November 15 event will feature a keynote presentation from NJ Assemblyman Dan Benson (D-15) followed by an educational panel featuring Caregiver stories. The event will be held at the Family Resource Network in East Windsor, NJ, from 8:30 – 11:00 a.m.

Click here for more information on the event

2020 Public Policy Sponsorship Opportunities Available  Bi oNJ’s Public Policy Support Series sponsorship opportunities are available for 2020. Sponsorship opportunities help make sure that our message is delivered in both Trenton and Washington, D.C. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship. More information is available here .

Thank You To Our Public Policy Support Series Sponsors

To learn how your organization can become more engaged in BioNJ's public policy efforts, please reach out to BioNJ's Vice President of Government Affairs, John Slotman , at JSlotman@BioNJ.org . Or, for information on BioNJ Membership, please contact Kimberly Minton at KMinton@BioNJ.org . Visit www.BioNJ.org for details.

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