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What’s Inside: Biocom California Engages on Orphan Drug Tax Credit; State Mask Mandate Expires; Webinar with NCI SBIR Director; Newsom Signs New Legislation; and More
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Last week, Governor Gavin Newsom and the State Legislature took a number of actions impacting Biocom California members, restoring the ability for companies to utilize both Research & Development and Net Operating Loss tax credits and reestablishing California’s COVID-19 supplemental paid sick leave program.
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Robert Califf Confirmed to Head FDA
On February 15, Robert Califf was confirmed as Commissioner of the FDA by a Senate vote of 50-46, with four Democrats voting against his nomination (Joe Manchin, Ed Markey, Richard Blumenthal, Maggie Hassan) and one Independent (Bernie Sanders). Just one day earlier on February 14, Senators voted 49-45 to end debate on Califf’s nomination, indicating that there was enough support to confirm him as Commissioner. The FDA has not had a permanent leader for more than a year into the Biden Administration. Dr. Califf previously held the role during the Obama
administration and will take over from Acting Commissioner Janet Woodcock.
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Biocom California Engages on Orphan Drug Tax Credit
On February 4, Biocom California submitted a letter to the House Ways & Means Committee, Senate Finance Committee, and the California delegation to express our support for the Orphan Drug Tax Credit (ODTC). The ODTC was halved in 2017 and recent proposals have sought to limit its availability for future indications. The letter emphasizes how the ODTC is a critical incentive in the Orphan Drug Act and has spurred innovation for rare disease patients for almost four decades. Biocom California will continue to urge Congress to ensure innovators have the incentives to conduct complex clinical research and refrain from further weakening
the ODTC.
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House Health Subcommittee Holds Hearing on PDUFA
On February 3rd, the Subcommittee on Health of the Committee on Energy and Commerce held a hearing entitled “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics.” The hearing served as an important first step in the Congressional process to reauthorize the User Fee Agreements that permit the Food and Drug Administration (FDA) to collect fees to facilitate the timely review of a product. The hearing encompassed the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA) agreements that were transmitted to Congress in January. Key provisions from each of the
agreements can be found in the Chairman’s memo and a full recap of the hearing by Biocom California staff can be found here.
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Biocom California Seeks Comments on EUA Transition
On December 23rd, FDA released the highly anticipated Transition Plan for Medical Devices Authorized under the Emergency Use Authorization (EUA). The Department of Health and Human Services (HHS) has not terminated the EUA declaration and FDA outlines that it would come with a 180-day notice. FDA seeks guidance on two topics: whether the 180-day period is enough to transition products without causing issues and whether this guidance meets the statutory requirement for consultation. Biocom California will submit comments on this draft guidance by the March 23rd deadline. Please contact Isabel Omer with feedback and comments on the draft
guidance by February 22.
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Biocom California Seeks Feedback on Digital Health Technologies
Recently, the White House Office of Science and Technology Policy, as well as the Republican-led Healthy Future Task Force in the House of Representatives, have put out two Requests for Information (RFIs) that focus on the impact of digital health technologies (DHTs) – Healthy Taskforce RFI and OSTP RFI. DHTs are innovative tools that hold incredible promise for understanding diseases, conducting clinical trials, and transforming
patient care. The information requested seeks to understand the impact and opportunities of these technologies as well as challenges that need to be overcome for more widespread adoption. Biocom California plans to submit comments to both of these RFIs in March. Please contact Rick White if you are interested in providing comments by Wednesday, February 23.
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House Passes COMPETES Act
On February 4, the House passed the America Creating Opportunities for Manufacturing Pre-Eminence in Technology and Economic Strength Act or America COMPETES Act. The bill includes $52 billion over five years for semiconductor research and development (CHIPS for America Act), in addition to $45 billion over six years for a new Supply Chains for Critical Manufacturing Industries Fund, expanding strategic stockpiles of medical supplies, and would reauthorize the SBIR/STTR program across agencies, among others. The Senate voted on their own legislation last summer. The two chambers will need to reconcile their versions to move the bill through the legislative process.
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Indoor Mask Mandate Expired for Vaccinated Individuals
On February 15, Governor Gavin Newsom allowed the statewide indoor mask mandate to expire for people who have been vaccinated against COVID-19. Masks are still mandated for school children and unvaccinated individuals pending further discussions. Local governments continue to enforce their own indoor masking requirements. The lifting of the mandate will apply to counties without local mask orders of their own, such as San Diego and Orange County.
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Additional Vaccine Mandates Considered as COVID Cases Decline
As COVID-19 cases are declining throughout California, matching the pattern nationwide, California lawmakers are proposing steps to keep the transmission low among the youngest constituents. A new package of bills have been introduced to increase vaccination rates. Assembly Bill 1993 will mandate all employers to require employees to be vaccinated. Senate Bill 871 will add COVID-19 vaccines to California’s list of required inoculations for attending K–12 schools, with exemptions only for rare medical conditions. And Assembly Bill 2098 would make promotion of vaccine misinformation by physicians a form of unprofessional conduct, subjecting doctors to disciplinary measures. The bills are expected to be met with strong opposition from anti-vaccine activists.
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San Diego
Proposed San Diego Parcel Tax Postponed
A measure for a proposed parcel tax in San Diego that would upgrade parks and libraries will be targeted for the November 2024 ballot instead of this year. Supporters say the delay will allow for more time to raise money and collect signatures and that the measure will have a better chance of approval during a presidential election when turnout is higher. The proposed measure would raise roughly $250 million to upgrade deteriorating parks and renovate older libraries including projects in low-income areas.
San Diego Community Power Rollout
Residential customers in San Diego, Chula Vista, La Mesa, Encinitas, and Imperial Beach will receive power from a new electricity provider as early as February. San Diego Community Power (SDCP) will service more than 700,000 residential customer accounts and determine power purchase contracts for those five cities instead of San Diego Gas & Electric. New customers will receive information in the mail explaining SDCP, the change, and what options are offered. Commercial and industrial customers started receiving SDCP service last summer.
San Diego Approves Housing Package
On February 8, the San Diego City Council approved Mayor Todd Gloria’s housing package, “Homes for All of Us,” which includes housing incentives and regulation changes that will spur the construction of more housing units and respond to some concerns about preserving neighborhood character. The package tightens some rules for accessory dwelling units (ADUs) and softens the potential impact of a state law allowing up to four dwelling units on many single-family lots.
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Los Angeles
Los Angeles County Continues Masking Indoors
Los Angeles County remains on track to lift the outdoor mask mandate on February 17 with the number of COVID-positive patients in local hospitals continuing to decrease. Under guidelines announced this month by county Public Health Director Barbara Ferrer, hospitalization number must stay below 2,500 for seven consecutive days for the county to be considered in a “post-surge” phase and lift the mask mandate for outdoor events. While the county’s outdoor masking requirements could be lifted by Wednesday, the indoor masking mandate will remain in place until stricter criteria are met.
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Bay Area
State Mask Mandate Lifted, County Restrictions Could Change
As the California statewide mask mandate for vaccinated individuals expired this week, all Bay Area counties, except for Santa Clara County, announced in a joint statement that they will align with the state decision to lift universal mask requirements for vaccinated people in most indoor public settings starting on February 16. For businesses, the California Labor & Workforce Development Agency (LWDA) has developed an online tool that pulls up local guidelines to operate and reopen safely.
City of Palo Alto Considering a Change to Business Taxes
Palo Alto City Council is considering raising its annual business taxes under a new proposal. City Council has until August to decide whether to move forward with a proposal for the November ballot that would keep the current business license fee of $50 per year for businesses under 5,000 square feet and charge between 5 – 20 cents per square foot per month on any space beyond that. With this proposal, the city could bring in between $11.7 million and $46 million per year.
Proposed Paid Leave Ballot Measure for San Francisco
San Francisco Supervisor, Gordon Mar, proposed a ballot measure for June 2022 to make paid emergency leave permanent. The measure would require companies with 100+ employees globally to provide additional paid leave during a health emergency related to any contagious, infectious, or communicable disease as declared by the local or state health officer. The proposal was heard at the Supervisors February 14 Rules Committee meeting and it will return for a final hearing and recommendation on February 22 following amendments.
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Bay Area Policy Working Group Meeting – January 28
On January 28, Biocom California’s Public Policy team hosted this year’s first Bay Area Policy Working Group meeting to gather input from members on our policy priorities for the year and discussed future plans for meeting topics. We were excited to have our newly confirmed working group co-chairs to lead the meeting: Shelly Guyer, Chief Sustainability Officer, Invitae, and Bharath Kumandan, Sr. Director of Business Operations & Strategy, Aligos Therapeutics.
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Thursday, February 17
Virtual
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Join us for a webinar with Matthew McMahon, Director, SEED and Michael Weingarten, Director of NCI SBIR, to learn about how to submit SBIR/STTR applications, eligibility requirements, funding opportunities, and more.
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Friday, February 18
Virtual
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Join Biocom California and Fisher & Phillips for an overview of the new legislation providing extension of COVID-19 supplemental paid sick leave and tax credits for small businesses.
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Thursday, February 24
Virtual
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Join us for a PDUFA 101 briefing for Congressional Staffers to learn more about why the program was created, how it works, and how it provides resources to the FDA.
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Friday, February 25
Virtual
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Join us for this year’s first Biocom California quarterly Bay Area Facilities/EH&S Committee meeting to give input on priorities of interest for the year.
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Emily Cassel
Associate Manager, Govt. Affairs & Events
San Diego
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Laure Clark
Sr. Director, Federal Policy & Govt. Affairs
Washington, D.C.
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Melanie Cohn
Sr. Director, Regional Policy & Govt. Affairs
San Diego
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Jimmy Jackson
Senior Vice President & Chief Policy Officer
San Diego
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Izzie Omer
Associate Manager, Regulatory Policy
Washington, D.C.
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Richard White
Associate Manager, Federal Advocacy
Washington, D.C.
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Biocom California Advocacy
Biocom California is the largest, most experienced leader and advocate for California’s life science sector. Our public policy staff is strategically located in the Bay Area, Los Angeles, San Diego, Sacramento, and Washington, D.C. We work with all levels of federal, state, and local governments to collectively pursue outcomes that benefit regional life science growth and contribute to a more innovation-friendly state. With over 25 years of experience, Biocom California works on behalf of more than {{{dynamic_content_1600}}} member companies statewide.
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