The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA).
Glenn Stiegman, MCRA
Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a potential market value of $544 billion by 2020 based on current growth rates among an ever-aging population. However, the government’s plans for the FDA could endanger this growth story.
The advance in device technology is exerting tremendous pressure on the FDA to help speed approvals for new or improved orthopedic technologies. The FY2018 Presidential Budget Request (PBR) recognizes the need to increase the number of reviewers able to streamline the process without lowering the threshold of review quality – but without the requisite increase in funding.
Our consulting firm recently undertook an analysis of the government’s budget request to assess its ability to get the job done. One glaring weakness is the budget’s capacity to pay for the review of the anticipated increase in Premarket Approval Applications (PMAs), 510(k)s and de novo submissions, a crucial concern for the industry.
PMAs represent a regulatory pathway for the most innovative technologies and provide a benchmark for assessing fees for other FDA services such as 510(k)s, PMA supplements and other forms of submission. Cutting the Medical Device Review Program budget could lengthen approval times, weaken the quality of review process and complicate communications between the FDA and the industry. Left to fester this would not only mean higher regulatory and financial barriers but also create market instability and hurt patients.
The FDA Center for Devices and Radiological Health (CDRH) has to ensure the safety and effectiveness of medical devices through a Review Program that offers a range of regulatory pathways. Since 2012, CDRH has improved review times of PMA and 510(k) programs.
Its FY2016 Performance Report said 100% of all PMAs and 98% of 510(k) submissions were completed within established goals of 390 days and 130 days, respectively, compared to 2013 figures of 84% of PMAs and 95% of 510(k)s.
However, continuing performance improvement hinges on adequate funding. The FDA is primarily funded by a budget appropriated through Congress. This budget is supplemented by user fees paid by participating companies. Fees are determined, reauthorized or updated every five years.
The user fees for fiscal years 2013–17 cover the costs of FDA reviewer salary and benefits. Most FDA user fees for larger medtech companies are set to jump another 33% at the start of the 2018 fiscal year – Oct. 1 – under the Medical Device User Fee Amendments of 2017 (MDUFA IV) that Congress recently passed.
The current PBR recommendation is to cut the overall FDA budget by $870 million (–31.6%). This includes a $243 million cut in the Medical Device Review Program. The PBR suggests an increase in user fees averaging 70% to accommodate the shortfall unless there is a parallel increase in the volume of regulatory submissions. Plainly this will throw a spanner in the works. Currently, companies are able to commercialize new technologies in the US within a dependable timeline.
We are told that these budget cuts will not reduce the number of product reviewers, there may be other consequences. We anticipate an increase in review times and affects on the quality of reviews themselves possibly raising the level of regulatory hurdles. As a former official of the FDA, I expect that a budget contingent upon raising 70% more in user fees will lead to declines in the volume of medical device submissions and therefore the level of innovation.
Furthermore, the use of 510(k)s and de Novo will also decline due to budget shortfalls and the possibility of staffing cuts at the FDA – not to mention those at the industry level.
It is critical to develop an integrated clinical and regulatory strategy that guarantees the quality and effectiveness of devices.
Whether or not the PBR passes, significant changes are inevitable when a presidential administration and Congress pushs for fundamental change in an organization so complex and specialized as the FDA. It is vital that both the government and the healthcare industry ensure doctor and patient confidence. Device makers in particular must seek and secure the greatest level possible of expertise and experience in navigating this regulatory maize to avoid potential disasters.
Glenn Stiegman is SVP of clinical & regulatory affairs at Musculoskeletal Clinical Regulatory Advisers (MCRA), based in Washington, D.C. Prior to joining MCRA in February 2006, Stiegman served as chief of the Orthopedic Devices Branch at the FDA, after serving as a reviewer and team leader on many state-of-the-art spinal technologies.