Colorado BioScience Association (CBSA) and our national partners support the critically important reauthorization of the U.S. Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements and updates to the Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act. 

In a 13-9 vote, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The act reauthorizes most of FDA’s user fee programs and includes major provisions, such as Certificates to Foreign Governments (CFGs) and predetermined change control plans (PCCP). The legislation also encompasses the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give FDA additional authorities to regulate in vitro diagnostics (IVD), including laboratory-developed tests (LDTs).

If passed by the Senate, this version of the bill would have to be reconciled in conference with the user fee authorization bill, H.R. 7667, the Food & Drug Amendments of 2022, that was passed last week by the House in a 392-28 vote. The current user fee programs expire at the end of September.

CBSA’s Advocacy Work:

These important programs help bring safe, effective, and innovative therapies and technologies to patients in Colorado and across the United States. CBSA continues to advocate with the Colorado Congressional Delegation on the important and critical policy components of the FDASLA, User Fees, VALID Act and other key amendments (see below). These programs provide significant resources and capacity for FDA, greater predictability for the industry, and are in the best interests of patients in Colorado and nationally.
 

Amendments of note that passed:

• Streamlining the approval process for generic drugs. National partners oppose this provision and will continue to push for its omission going forward. The amendment as written would require disclosure of expanded qualitative and quantitative data sets and risk revealing private trade secret information.
• The VALID Act passed out of the Senate HELP Committee. CBSA applauds the committee and Senator Michael Bennet for leadership on the VALID ACT. The VALID Act would establish a new regulatory structure to ensure that accurate and high-quality diagnostic tests are available for Coloradans, especially those with rare diseases and conditions.
• Improving reporting of medical device safety issues by allowing the FDA to access emerging signals for post market device safety concerns.
• Implementing and clarifying the Certificates to Foreign Governments (CFGs to show that devices meet applicable FDA requirements. Many countries require CFGs, but the FDA has been inconsistent in how it applies them. The legislative language would ensure consistency so the products the FDA already deemed safe and effective could be imported and exported more efficiently, reaching more patients.
• Allowing the FDA to implement predetermined change control plans (PCCP) for medical devices. This means device companies would include future changes to a device in a premarket submission and would be able to make those changes after approval without having to undergo additional FDA review. 

Amendments of note that failed:

• Allowing importation of prescription drugs from the UK and Canada failed by procedural vote. CBSA will continue to monitor and advocate for the exclusion of importation as the legislation continues.

Amendments of note that were tabled:

• Exempting academic medical centers from VALID was offered and tabled; CBSA looks forward to working with the academic medical centers on VALID moving forward.

Both the House and Senate bills represent a win for the industry based on where discussions started. CBSA will continue to stay actively engaged throughout the process and will advocate for policies that lead to greater consistency, predictability, and transparency in the FDA review programs and help to bring safe and effective innovative therapies and technologies to patients here in Colorado and nationally.