What’s Inside: Congress Passes Drug Pricing Legislation; Update and Comparison on FDA User Fee Bills; First Female Director of NCI Appointed; Pasadena HazMat Rule Changes; and more.

Congress Passes Drug Pricing Legislation 

On August 12, the U.S. House passed 220-207 the Inflation Reduction Act (IRA), which contains drug pricing legislation allowing Medicare to set pricing on prescription drugs for the first time in U.S. history. The Senate had passed the bill on August 7 by a 51-50 vote. The bill establishes a cap on out-of-pocket patient spending, which Biocom California supports, but imposes steep price controls on an increasing number of Medicare Part B and D drugs over the years. Price controls have been proven to destabilize innovation ecosystems by driving capital investments away, chilling research and development, and eliminating jobs. Ultimately, they reduce the number of medicines being developed and reaching patients. A recent study by Vital Transformation has estimated that the bill would reduce innovators’ revenue by at least 55 percent, putting 104 out of 110 drugs or 95 percent of the pipeline at risk of cancelled development, and costing California over 100,000 jobs. In response to the legislation, Biocom California CEO, Joe Panetta, released this statement.

Federal Affairs

User Fee Legislation Comparison and Update

FDA user fee negotiations are in a stalemate since Sen. Richard Burr (R-NC) offered narrow legislation that would only implement the negotiated user fee commitment letters and reauthorize existing FDA programs. We expect all parties to reach a definitive proposal before the programs expire on September 30 and staffing reduction notices are issued. Biocom California continues to engage and has developed a comparison document of the three existing user fee bills for members’ benefit. 

Make Your Voice Heard! Biocom California Action Center Revamped

Biocom California has completed a redesign of our Action Center so we can more effectively connect our members with policymakers at all levels of government. If you are interested in making your voice heard, check out our existing alerts or sign up to receive future notifications. Currently, our most urgent call to action is to urge Congress to reauthorize the SBIR/STTR programs which are expiring on September 30 and fund many small companies’ federal grants throughout California. The Action Center can also help you find legislation or your representatives in Congress. Check it out today! 

First Female Director in NCI’s 85-Year History

Accomplished surgical oncologist, Dr. Monica M. Bertagnolli, will be appointed by the Biden Administration to lead the National Cancer Institute (NCI) at the National Institutes of Health. Dr. Bertagnolli, who holds positions at Harvard Medical School, Brigham & Women’s Hospital, and the Dana-Farber Cancer Institute, is expected to transition into her new role as NCI Director in the fall.

EPA Warns High Risk Communities of Ethylene Oxide Emissions

The Environmental Protection Agency (EPA) has alerted 23 commercial sterilizers that their air emissions from ethylene oxide (EtO), a chemical used to sterilize medical devices, may pose serious health risks to surrounding communities. The agency hosted a webinar on August 10 to discuss EtO risks and is expected to publish proposed air toxic emissions rules by the end of 2022.  

State Affairs

California Governor Announces Plan to Boost Water Supply

Two weeks ago, Gov. Gavin Newsom announced a $8 billion strategy to boost water supplies that focus on four pillars: building additional storage, increasing recycling and reuse of wastewater, increasing conservation and building more desalination capacity. The plan received widespread support from water users and business groups while also facing criticism from environmentalists. Find out more about the plan here and here.

California State of Emergency for Monkeypox Outbreak

Gov. Gavin Newsom declared a State of Emergency for monkeypox on August 1, triggering a set of legal powers and changes to enable a more robust response to the outbreak. A week prior, San Francisco had declared its own state of emergency followed by Los Angeles County on August 2 and San Diego County on August 9. Unlike COVID-19, this state of emergency is unlikely to result in shelter in place orders or other restrictions. Instead, the order allows additional personnel to administer vaccines.

Regional Affairs

Pasadena HazMat Rule Changes Receives Council’s Approval

Pasadena City Council gave final approval on August 8 to updated hazardous materials rules that will conform with state policy. These policy changes were initiated in the city by Biocom California and our members there. City staff now has 60 days to return to council with a proposed update to the hazardous materials ordinance.

UC Plan Update and Community Planning Group Reform in San Diego

The University Community Plan, the document that will dictate land use and public amenities in UTC for the next 20-plus years, continues its years long update process with a new set of development scenarios set to be presented to the plan update committee on September 20. Biocom California staff holds a seat on the committee and is advocating for policies that will allow for continued industry growth in this area. Community Planning Group reform, Councilmember Joe LaCava’s effort to expand access to local groups that provide input on construction projects, goes to city council on September 13. 

Other San Diego Transportation and Planning Updates

SANDAG’s draft 2023 Regional Transportation Improvement Program (RTIP) has been extended for public review to August 27, with a public hearing set for September 9. Mira Mesa is in the process of drafting a new Community Plan Update. The plan is looking to take a detour away from strip malls and suburban office parks and is moving instead to pedestrian-friendly infrastructure.

Bill to Create New San Diego Housing Agency Dies in Committee

Senate Bill 1105 didn’t make it out of the Appropriations suspense file. It was authored by State Sen. Ben Hueso and championed at the local level by Supervisor Terra Lawson-Remer. The bill would have created a new public agency to focus on low-income housing across San Diego County with the authority to put tax measures on the ballot.

State Launches First-Ever Housing Policy Review in San Francisco

The Department of Housing and Community Development announced on August 9 that it will be conducting a review of housing policy in San Francisco, which according to self-reported data has the longest timelines in the state for advancing housing projects to construction. The review is aimed at identifying and removing barriers to approval and construction of new housing and comes after the department rejected the first draft of San Francisco’s Housing Element. The process is expected to take at least nine months.

Alameda Gets New Interim City Manager

On August 9, Alameda city council voted unanimously to appoint Nancy Bronstein as interim city manager. She will be sworn in at the council meeting on September 6. Bronstein is currently acting city manager and previously served as the city’s human resources director and acting finance director.

Give Your Input on the Bay Area Ferry

What do you want the future of Bay Area water transit to look like? The San Francisco Bay Area Water Emergency Transportation Authority (WETA) is currently developing a shared vision of the San Francisco Bay Area ferry system in 2050. Explore the Bay Ferry 2050 website to take a quick priorities poll, subscribe, and help WETA re-imagine the future of water transportation.

Measure to Restrict Multifamily Housing Heads to Menlo Park Ballot

Menlo Park City Council voted on July 26 to place a measure on the November ballot that would require any rezoning of single family neighborhoods in the city to be approved by voters. According to a report commissioned by the council, if the measure passes options for housing development sites could be greatly reduced.

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