CBSA and our national partners support the renewal of the critically important User Fee Agreements, including the Pharmaceutical Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). Without Congressional action, PDUFA and MDUFA will expire in September. CBSA supports policies that lead to greater consistency, predictability, and transparency in the Food and Drug Administration’s (FDA) review programs and help to bring safe, effective innovative therapies and technologies to patients.

Senate Health, Education, Labor & Pensions (HELP) Committee Ranking Member Richard Burr (R-NC) recently withdrew from renewal conversations due to his disagreements with policies added during the Committee markup and provisions in the House bill. It is reported that after he withdrew from conversations, he then introduced the Food and Drug Administration (FDA) Simple Reauthorization Act. This legislation would reauthorize the four expiring FDA user fee programs (prescription drug, generic drug, biosimilar and medical device) without any additional FDA policy riders.

Senator Burr’s bill is an alternative to the other two proposals (one in the Senate and the other in the House) to reauthorize the FDA user fee agreements:

• The Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, which the HELP Committee reported favorably out of Committee with a bipartisan 13-9 vote last month. 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 Food and Drug Amendments of 2022, which passed the House in June with a bipartisan vote of 392-28. The House-passed version of the FDA user fee reauthorization proposal contained additional FDA policy riders, including requirements for clinical trial diversity and modifications to FDA’s accelerated approval pathway.

Despite negotiations, it is reported that leaders in D.C. remain optimistic that the programs will be reauthorized before the September 30^th deadline.

CBSA Engagement

These important user fee 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 and the absolute need to reauthorize the User Fee Agreements. These programs provide significant resources and capacity for the FDA, greater predictability for the industry, and are in the best interests of patients.

Predetermined change control plans (PCCP)

In addition to the user fee reauthorization, CBSA is advocating for other provisions to be included in the final reconciled bill, including predetermined change control plans (PCCP).  Predetermined change control plans were included in the FDASLA Senate Help version and are championed by Senators John Hickenlooper and Mike Braun.

The PCCP rider allows a manufacturer, when submitting a new device or technology to the FDA, to also submit a predetermined change control plan outlining future planned modifications to the product along with acceptance criteria and testing necessary to validate and support the specified changes. The FDA would still retain the authority to thoroughly review and approve the change control plans. Once in place, the medical device manufacturer could make modifications to the device within the scope of the change control plan without having to utilize the current, often-lengthy product submission process.

CBSA and our national partners see this as a more efficient use of FDA and industry resources that would expedite patient access to innovative therapies, treatments, and technologies, while also maintaining the FDA’s safety and effectiveness authorities and standards. CBSA encourages Colorado members of the House of Representatives to also include similar provisions and urge this amendment to be included in a final passed piece of legislation.