The Impact of Biofilm Regulatory Policy on the Development of Healthcare-related Products, Study 2
Paul Sturman, Ph.D., PE, Center for Biofilm Engineering
Frank Kerins, Ph.D., B.A., B.S., M.S., M.B.A., Jake Jabs College of Business & Entrepreneurship
Omar Shehryar, Ph.D., Jake Jabs College of Business & Entrepreneurship
The IRAEA supported the precursor to this second study, specified in a grant submitted in November 2016. The primary objective of the 2016 proposal was to prepare and administer a survey to stakeholders in the development of biofilm products including developing companies and regulatory agencies, particularly the EPA and FDA. These surveys have been developed, reviewed, and administered.
Initial results support the assertion that regulators and product developers have discordant views on issues surrounding terminology and regulatory approval process. Among corporate respondents, 96.4 percent rejected the idea that “anti-biofilm” and “anti-infective” are interchangeable terms. This implies that anti-biofilm product developers see their products as a distinct category which merits commensurate consideration by regulatory agencies. However, the FDA does not acknowledge “anti-biofilm” formulations as a separate class of products. Additionally, corporate survey respondents indicated that the regulatory approval process for bio-film related products is more cumbersome in the United States. Approximately 43 percent of the respondents disagreed with a statement that the regulatory process is easier in the USA.
An unforeseen limitation of the previous research turned out to be the lower than expected response rates from the regulatory survey. We attribute the low response rates to the current political climate.
To address limitations and to build upon previous research, this project will build upon our results and will utilize a study of comparison of patents granted in the USA and the EU for anti-biofilm products. We will also develop an in-depth interview protocol and conduct in-depth interviews of anti-biofilm product stakeholders. Given low response rates, we are limited in utilizing inferential statistics. Thus, an in-depth interview methodology will enable us to better answer the lingering questions regarding the approval process for anti-biofilm products in the USA.
Bacterial infections associated with medical devices and hospital procedures account for an enormous and growing portion of heath care-related costs and patient mortality. Health care-associated infection (HAI) alone cost approximately $30 billion in potentially preventable expenditures annually. The US Department of Health and Human Services (HHS) has identified biofilms as an important etiological agent in HAI, but the EPA and FDA have not made a similar recognition. This research analyzes if prohibitively restrictive regulatory policies inhibit anti-biofilm product development efforts. The proposed research builds on surveys that have been administered to industry stakeholders to assess the impact of these regulatory policies on decision making at both health care companies developing anti-biofilm products as well as agencies regulating them. This project proposes to interview stakeholders in anti-biofilm product development to better understand the implications of regulation in these markets.
The principal aim of this work is to use interviews of anti-biofilm product stakeholders to understand and report how regulatory policy at the national level influences decision making at healthcare-related businesses, specifically with regard to the development of products designed to prevent or mitigate HAI associated with biofilms. It was our hypothesis that an ambiguous and/or overly cautious regulatory climate inhibits innovation in this area. We received some support for this hypothesis. A majority of corporate respondents (82%) stated that the lack of clear guidance by regulatory agencies is inhibiting product development. However, regulators asserted that applicants often submit incomplete and insufficient documentation which slows the approval process. Unfortunately, the low sample size of the regulatory survey sample prohibits us from drawing meaningful conclusions. We suspect that the current political climate will make it difficult to achieve survey responses. Thus, a better approach may be to approach regulators individually and obtain confidential responses using in-depth interviews. These interviews will provide further insight into the regulatory-obstacle hypothesis. The alternative hypothesis is that recognition of biofilms as an important etiological agent in HAI is not essential to the FDA and EPA achieving the public health outcomes consistent with their missions.
The rationale for this work is the current exorbitantly high cost of HAI, both in expenditures and human life, the fact that innovative technologies for biofilm control exist but have yet to be fully integrated into the health care product arsenal, and that the balance of risk versus safety that necessarily drives regulatory decision making may be too cautious in light of the magnitude of the HAI problem.
Significance of the Project
This research will identify and interview stakeholders associated with the development of medical devices intended to mitigate biofilm, either on the device itself or on tissue in contact with the device. It will seek to better understand the experiences of the regulated community (medical device manufacturers) and the extent to which a lack of clear FDA guidance on the approval process for biofilm-related devices has delayed or inhibited new product innovation. We anticipate that the results of this work can be used within the agency to better understand the implications of their current methods of review and develop a more efficient process going forward. This work will broaden public understanding of the societal impacts of medical device regulation, which is central to CRAEA’s mission. Bringing a new or innovative medical device to market is often an enormously expensive undertaking. The progression from basic research and development, to laboratory models, pre-clinical testing, and finally clinical testing can easily cost tens to over 100 million dollars. The FDA’s role as protector of public health is not in question, however, it must also be noted that unnecessary delays or expense in bringing potentially life-saving products to market may be counterproductive to innovation and the adoption of new technologies. FDA’s position is particularly problematic with regard to biofilms because of the failure to recognize persistent infection and surface associated bacterial growth as essentially biofilm problems.