California Life Sciences asks Congress to quickly pass user fee agreements to fund the FDA


September 13, 2022

Dear California Delegation and Congressional Leadership,

On behalf of California Life Sciences (CLS), I am writing to urge timely reauthorization of user fee agreements for fiscal years 2023-2027 before the programs expire on September 30th.

CLS is the state’s most impactful life sciences membership organization. For more than 30 years, CLS has served the community by supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in the fields of biotechnology, pharmaceuticals, and medical technology. As integral components of a healthy and collaborative ecosystem, CLS also works closely with universities, academic and research institutions, the investment community, and other critical partners that promote this vibrant sector. Our mission is to protect and nurture California’s life sciences ecosystem, empowering discoveries that lead to healthier lives around the world.

The Food and Drug Administration’s (FDA) User Fee Programs – the Prescription Drug User Fee Act, the Medical Device User Fee Act, Generic Drug User Fee Act, and the Biosimilar User Fee Act – are critical to enable the FDA to fund workforce and new technology to ensure timely review of drug and device applications so that products can get to patients faster. If the programs lapse and funding runs out, the FDA will be forced to lay off critical employees, thus delaying patients’ access to new drugs and devices that can save and improve lives. Timely reauthorization of these programs will allow the FDA to better integrate the patient voice and experience into the drug and device development and review processes, build upon lessons learned from the pandemic, and ensure more inclusive clinical trials. These programs have strong, bipartisan support in Congress, and we urge lawmakers to act.

Additionally, we would like to highlight our positions on several critical issues within the User Fee Programs:

• CLS strongly supports the Accelerated Approval Pathway to expedite approval of drugs to treat serious and life-threatening diseases. We support improvements to the pathway that ensure it continues to work effectively for patients, but caution against changes that would make the program more stringent.
• CLS supports House-passed language that would lead to clinical trial diversity plans to ensure trials represent the full patient population and to help advance
health equity. Breaking down barriers to participation by decentralizing trials and utilizing digital technology will help facilitate increased diversity. We appreciate the attention paid to the challenges associated with enrollment in rare disease clinical trials.
• CLS supports language included in the Senate Health, Education, Labor, and Pensions (HELP) Committee-passed bill with regard to when and how the FDA must issue ‘Certificates to Foreign Governments’ to show that devices meet applicable FDA requirements. The provision would ensure consistency so the products the FDA already deemed safe and effective could be imported and exported more efficiently.
• CLS urges inclusion of an amendment approved by the Senate HELP Committee on a voice vote that would allow the FDA to grant predetermined change control plans, allowing a device manufacturer to submit proposed post-market device modifications with its initial submission to the FDA.
• CLS supports language included in both chambers’ bills that would provide for alternatives to animal testing. Many of our members are working on innovative approaches to research to improve disease understanding and to identify drug candidates faster with reduced need for animals in research.
• CLS remains concerned about the inclusion of provisions that require the FDA to allow the importation of prescription drugs from abroad.

Since inception, the user fee programs have been invaluable to accelerating patients’ access to safe and effective drugs and devices. In addition to approving new innovative therapies, they also provide patients with faster access to safe and effective generic and biosimilar medicine, thus ensuring more affordable access for patients.

Congress must act in a bipartisan manner to reauthorize these programs before they expire this month. Patients deserve timely reauthorization, and CLS stands ready to work with the California delegation to make this happen.

Thank you for your consideration,

Mike Guerra
President & CEO
California Life Sciences