What’s Inside: FDA User Fee Negotiations Ongoing; Drug Pricing Bill Introduced in Senate; Biocom California Initiates Pasadena HazMat Rule Changes; State Opens Applications for Next Round of California Competes Credits and Grants; and more.

User Fee Legislation Negotiations Ongoing

The House and Senate are working on developing final user fee legislation. Reauthorization is still expected before the user fee program expires on September 30 and the FDA is forced to reduce staff capacity. Biocom California has submitted input to the Hill on key points and will remain engaged as negotiations continue in August.

Federal Affairs

Senate Unveils Resurrected Drug Pricing Legislation

In early July, the Senate unveiled a drug pricing proposal akin to the proposal from last fall. Senate Democrats are attempting to resuscitate a highly similar version of the reconciliation package from last year to address President Biden’s domestic policy agenda. This week, the Senate Parliamentarian will rule if the bill is able to be considered under reconciliation rules. Biocom California is engaged in once again ensuring these harmful policies do not get passed into law.

Senate Passes Semiconductor Chips Legislation

Today, the Senate passed 64-33 legislation to provide $52 billion in grant funding and an investment tax credit for the manufacturing of semiconductor chips (CHIPS Act). The bill also includes new funding for the National Science Foundation, National Institute of Standards and Technology, and Energy Department. The bill is a scaled-back version of House- and Senate-passed U.S./China competitiveness bills and the result of months of bipartisan negotiations. The House is expected to vote on the bill before the August recess. Biocom California strongly supported the CHIPS Act but will continue to advocate for the passage of our other priorities that were not included in the bill (view our letter to Congress), most urgently the reauthorization of the SBIR/STTR programs, which provide federal research funding to small companies.

Biocom California Co-hosts Antimicrobial Resistance Webinar

On July 18, Biocom California, along with Life Sciences PA and several other state associations, held a virtual briefing for congressional staff on the importance of Antimicrobial Resistance as a public health threat. At the briefing, the panelists discussed policy proposals to incentivize the production of drugs to treat AMR. AMR is a growing public health crisis, and we will continue to engage on this important issue.

Biocom California to Comment on FDA Draft Guidance 

Biocom California plans to comment on the FDA draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages. The comment letter provides the Agency feedback on Risk Management Plans (RMP) and stakeholder information exchange, risk control strategies, RMP development, and more. To view a draft of the comment letter, please email Zoe Bilis. 

CMS Proposes CY 2023 Physician Fee Schedule 

On July 7, the Centers for Medicare and Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) proposed rule on policy changes for Medicare payments. In addition to discussing PFS rate setting, some of the proposed rule topics include telehealth services, skin substitutes, and manufacturers providing refunds for discarded single-dose containers. To send comments on the proposed rule, please email Zoe Bilis. 

State Affairs

Applications Open for $85M in California Competes Tax Credits 

The California Competes Tax Credit (CCTC) is an income tax credit available to businesses that want to relocate to or expand in California. Biocom California was a key partner in creating this program and many growing life science companies have been successful in their applications. The application deadline is Monday, August 15, and this round has $85 million in available tax credits and $120 million in grants. Interested businesses can register to view a live webinar which explains the application process. The online application can be accessed at calcompetes.ca.gov. Learn more about the CCTC through free application webinars on August 4 and August 9.

New California Plastic Law Could Create Supply Chain Changes

A recently enacted law will ban many single-use plastics and packaging materials commonly in use today. Gov. Newsom signed the new act into law in June as part of a deal to remove a more onerous ballot measure from the November 2022 General Election Ballot. Biocom California has worked since 2019 to secure carve-outs for certain medical products, including prescription drugs and medical devices. Companies have several timelines to meet for compliance and are strongly encouraged to carefully review the new law with counsel and be advised that some supply chain changes are likely coming in the years ahead. Biocom California supports access to safe and effective healthcare products. For more information, please contact Fielding Greaves. 

Regional Affairs

South San Francisco Parcel Tax Could Hurt Biotech

A tax measure to fund childcare in South San Francisco is headed to the November ballot. The initiative would impose a $2.50 per square foot parcel tax on commercial buildings larger than 25,000 square feet. Biocom California plans to convene our members in South San Francisco to consider an official position opposing the measure and participating in an opposition coalition. 

LA Could Avoid Reinstated Mask Mandate

As coronavirus cases decline, Los Angeles County could hold off on its previously announced reinstatement of a universal indoor mask mandate that was set to take effect July 29. The county will decide this Thursday, based on CDC community levels, whether the mandate will be reinstated. 

Biocom California Initiates Pasadena HazMat Rule Changes

On July 20, Pasadena City Council’s Public Safety Committee moved forward with the Fire Chief and Biocom California’s recommendation to increase the permitting threshold for designated hazardous materials from any amount of a material to state minimums. The committee will consider moving this forward to the city council at their next meeting on August 17.

Board Approves Plan to Support Life Science Growth in Los Angeles

The LA County Board of Supervisors approved a motion by Chair Holly Mitchell to direct county resources toward growing the region’s life science industry. Biocom California will work in partnership with the county to bolster startups, talent, and land use rules supporting the industry.

Sustainability Updates from Around San Diego

The County of San Diego is recruiting for a Chief Sustainability Officer to help the county achieve its sustainability goals and ensure all communities benefit from measurable climate action. The City of San Diego’s updated Climate Action Plan – Net Zero by 2035 heads to council for final approval on August 2. 

San Diego Might Raise Water Rates for Second Year in a Row

San Diego City Council voted this month to set a public hearing to consider a potential water rate increase. Rate changes would be a pass-through from the San Diego County Water Authority increase that was approved in May due to inflation, increased energy costs, and rate hikes set by the Southern California Metropolitan Water District. 

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