Weekly Policy Blog: CBSA’s Continued Advocacy on Important Federal Policy Initiatives

Congress is negotiating sweeping legislation that impacts life sciences. Colorado BioScience Association (CBSA) remains active on these important legislative proposals, which include supporting the reauthorizations of PDUFA + MDUFA, urging reauthorization of SBIR + STTR programs, monitoring and advocating for the VALID Act, and engaging on the recent reconciliation package that includes updated drug pricing text. 

Updated Drug Pricing Text in the Senate

Democrats in the U.S. Senate continue to negotiate a prescription drug pricing proposal that would drastically alter the Medicare program and healthcare subsidies.

The current reconciliation bill includes language that imposes government price setting in Medicare, which could chill investment in next-generation treatments and cures for patients in need and result in significant job losses in the biopharmaceutical sector.

CBSA is working with our partners at BIO to urge Congress to support innovation for patients and oppose government price setting. Please take a few minutes to take action and write a letter to your member of Congress using our interactive tool.

Additionally, CBSA signed onto a letter with BIO and the Council of State Bioscience Associations (CSBA) to Senate Majority Leader Schumer, Senate Republican Leader McConnell, House Speaker Pelosi, and House Republican Leader McCarthy expressing serious concerns about government price setting in this proposal.

CBSA will continue to voice our concerns about the proposals with Senators Bennett and Hickenlooper. CBSA remains committed to advancing affordability solutions that correct market failures, increase competition, and lower costs for patients. Over the years, CBSA has opposed similar provisions that we’ve seen included in other legislative proposals, including allowing government negotiation in Medicare and imposing inflation rebates in Medicare Part B and D. Such proposals would destabilize the market-based system that determines the value of medicines and deter investment in life sciences innovation. The legislation as written does not adequately address the misaligned incentives in the healthcare system. CBSA encourages lawmakers to look at the system as a whole, reviewing the influential role insurers, pharmacy benefit managers (PBMs) and others play in deciding how much patients pay for medicines at the pharmacy counter. CBSA continues to coordinate with members and industry partners to voice our concerns and educate lawmakers about how these policies will limit patient access and stifle medical innovation.

Advocating for VALID ACT within Reauthorization of User Fee Programs

CBSA and several state life sciences associations, patient groups and other stakeholders signed onto a support letter led by AdvaMed to Chairman Pallone, Chair Murray, and Ranking Members Rogers and Burr. As negotiations for the user fee reauthorizations are ongoing, this letter reinforces CBSA’s and the industry’s commitment to ensuring patient access to accurate and reliable in vitro diagnostics. 

CBSA has previously signed onto support letters for VALID Act. As Congress works on reconciling differences between the user fee reauthorization legislation emerging from both the House and the Senate, it is important that they also address an urgent public health issue by enacting the diagnostics reform provisions included in the FDA Safety and Landmark Advancements Act (FDASLA), S. 4348. These provisions reflect years of continuous engagement and thoughtful collaboration among committee members, congressional leaders, and the stakeholder community.

The legislation addresses a longstanding issue that has been recognized by administrations of both parties. The current federal approach to oversight of this field has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for improved patient outcomes. As Congress finalizes the legislative package reauthorizing FDA’s user fee programs, it can also act on this opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests.

CBSA will continue to work with the Colorado Delegation as legislation moves forward and advocate for regulatory reform that can keep pace with innovation and ensure timely patient access to cutting-edge diagnostic technologies.

Categories: CBSA News