Changing FDA: Can the Agency Keep up with Science?
March 16, 2026FDA Attempts to Keep Up with Industry
Journal articles presenting new ways to diagnose and treat diseases appear almost daily. They offer promise for patients currently suffering from disease and for those patients who may face these conditions in the future. However, identifying a new way to approach disease is one thing; translating that scientific discovery into an approved medical product is entirely another.
To address this challenge, FDA has implemented programs intended to accelerate the development and review of innovative products. For example, the Breakthrough Devices Program seeks to partner with industry to help usher in promising technologies that address certain disease states. However, despite these efforts, many devices in this program ultimately fail to achieve market authorization.
FDA has instituted several pilot initiatives that are also aimed at speed to market. These range from commitments to provide a more thorough response via meeting minutes following an FDA interaction to expedited review for certain pharmaceutical products. In some instances, a single additional clarification via meeting minutes can prevent months of delay. More ambitious programs, such as the Commissioner’s National Priority Voucher Pilot Program, could shorten development timelines by months or potentially even years. However, these pilot programs remain limited in scope, and only a few drugs, based on acceptance criteria and leadership oversight, even qualify for the priority voucher program.
Concerns about regulatory timelines have also drawn the attention of Congress. Recently, Senator Bill Cassidy (R-LA) published a report examining FDA review practices and raised several concerns, among them time to market and FDA’s consistency in evidentiary standards. Senator Cassidy has championed expanding the use of least burdensome principles to guide FDA broadly, not just in medical device reviews. Senator Kirsten Gillibrand (D-NY) has likewise chastened FDA for its review timelines, especially for therapies addressing life-threatening or rare diseases.
Creating Real Change
“Speed to market remains a central concern for industry, FDA, and Congress, but meaningful change will require sustained collaboration between regulators and industry. Companies should ensure regulatory strategy is integrated into product development from the outset so they can engage FDA early and navigate evolving review pathways effectively.”
Both Democratic and Republican administrations have sought to improve regulatory efficiency at FDA. Members of Congress on both sides of the aisle have made statements and taken action in support of legislation designed to accelerate medical innovation. Nevertheless, the challenge of balancing timely access to new therapies with rigorous safety and effectiveness standards remains.
Creating meaningful change will take a robust FDA, not a reduced one. Congress needs to empower FDA with the personnel and tools necessary to engage with industry in real time on medical products that require thorough review while continuing to explore alternative regulatory pathways to market, including technologies addressed under the 21st Century Cures Act, such as certain clinical decision support tools.
Ultimately, the government and industry need to partner more than ever. FDA should be creative in its use of tools like special controls and post-market requirements to find paths to market for promising treatments. FDA should continue to utilize risk-based approaches wherever possible, as it has done in the TEMPO digital health devices pilot program.
Simultaneously, industry needs to understand that while the government continues to focus on the need for more efficient and consistent paths to market, change will not happen overnight. A regulatory strategy needs to be a part of every company’s standard documentation. Companies should proactively establish clear plans for when and how to approach FDA to resolve identified issues, anticipate potential evidentiary challenges, and proactively address regulatory questions as they arise. Early and transparent dialogue with the Agency can prevent delays later in the review process.
Medical innovation is surging. Ensuring that the benefits from these innovations ultimately reach patients will require sustained collaboration between regulators, lawmakers, and industry.
Contact Gardner Law
If you are embarking on the long journey of bringing a medical product to market, you must have a robust regulatory strategy in hand. The regulatory experts on our team understand the challenges facing FDA and can help you navigate the regulatory landscape.