Is peace breaking out between the FDA and the medical device industry as we head into 2012?
On December 7, Minnesota’s LifeScience Alley (LSA), the largest state-based life sciences trade association in the U.S., announced that it had signed a memorandum of understanding (MOU) with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to, “realign the day-to-day interactions between medical device companies and the FDA.”
Jeff Shuren, M.D., JD, CDRH’s director, said, “The FDA’s approach to regulation must be as smart and as innovative as the products we review. This MOU represents the beginning of important collaboration among industry, government and academia to strengthen the medical device industry and assure that Americans benefit from safe and effective medical products.”
Assuring access to safe and effective medical products is half of FDA’s defined mission to promote, as well as to protect the public’s health.
Smoother Regulatory Pathway
The effort to create a structured working relationship between the FDA and the device makers began last August when LSA hosted several senior members of the CDRH in Minnesota. Shuren; Deputy Director for Science, William Maisel, M.D.; Deputy Director, OSEL Joel Myklebust, Ph.D.; Director, Office of In Vitro Diagnostic Device Evaluation and Safety Director, CDRH Alberto Gutierrez, Ph.D. and Acting Deputy Director for Science and Regulatory Policy, ODE Jonette Foy, Ph.D., met with representatives of the Minnesota medical technology, academic and investment communities to discuss the advancement of regulatory science.
The hope, according to the trade association, was that if the tools for regulatory science could be identified and new devices developed using those tools, the path to regulatory clearance would be smoother. If the pilot works in Minnesota, it may serve as a national model for medical devices safety and clearance.
At the time of the visit, Shuren said that such a broad public-private partnership involving the FDA is a first for the medical devices industry, but noted that such a collaborative model already exist with drug makers. Maisel said that regulatory science has helped lay the foundation for new drug development.
In a sense, the MOU is an effort, according to some familiar with the agreement, to move the regulatory discussions to the scientist-to-scientist level and away from a highly political charged environment.
The Agreement
The four page document states that the FDA and industry have a “shared interest in promoting regulatory science for medical devices.” The agreement says these shared interests can be pursued “through a variety of programs including collaborative research, public outreach, extension activities, cooperative initiatives, and disciplinary training.”
In order to protect and promote public health, the FDA acknowledges it must “stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues.” And that’s where industry can help.
The types of activities expected to develop from the agreement include:
Identification and convening of a steering committee that includes industry leaders and University of Minnesota experts to guide a process for scientific and intellectual collaborations, outreach, and education initiatives.
Joint workshops and meetings for education and research.
Research collaborations in regulatory science; and
Sharing unique facilities and equipment for increased results and cost efficiencies for scientific endeavors.
Before starting a formal collaboration, the parties agree to identify “priorities, topics of mutual interest, and develop separate, written agreements that outline financial commitments and terms governing the collaboration.
Some general provisions of the agreement include:
Data Sharing Guidelines: There may be certain data and information that require confidential disclosure agreements where the FDA will not share any confidential commercial information or trade secrets with LSA without the permission of the owner of the information.
Intellectual Property: Nothing in the agreement will require any party participating in the program to disclose or license intellectual property.
Conflict of Interest: Non-government employees will be expected to abide by conflict of interest rules specified by the FDA. Participants may be required to disclose their financial holdings and limit their ability to be employed by entities regulated by the FDA. The parties agree to “avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.”
Shuren on the Impact on Orthopedics
We asked Dr. Shuren how this agreement might improve the process of developing devices, particularly in orthopedics.
Jeff Shuren, M.D.Shuren told OTW on December 15 that one possible area for collaboration between the FDA and industry is to develop methods to help companies bring to market such specific products as “lab on a chip.” “These devices, ” said Shuren, “are comprised of multiple laboratory tests on a hand held platform, which allows them to be used in a doctor’s office.”
Another area of collaboration, said Shuren, is for the parties to create new computer-based simulation models of the human body. “By refining these models so that they can be used to simulate different stages of disease development, we may reduce the need for animal and human testing of certain implantable orthopedic devices.”
Finally, Shuren pointed to potential collaborations for creating test platforms that assess the critical operating principals of classes of medical devices, such as the mechanical and electrical behavior of pacing or stimulus leads.
“By advancing regulatory science to create better tools to validate medical devices, the FDA can provide industry with tools to more quickly and thoroughly meet our regulatory requirements. By collaborating under the MOU on scientific advances, industry and the FDA can both speed important safe and effective devices to market and improve their working relationship.”
FDA Innovation Initiative
The collaboration between industry and the FDA comes at a time when the agency has been criticized by many in industry and the investment community for stifling innovation. Medical device review times have increased and the agency has become less predictable, consistent and transparent over the past few years. The average time to decision for a 510(k) submission increased to 146 days in 2010 from about 100 days in the first half of the decade and the average time to decision for Premarket Approvals (PMAs) steadily increased over the past ten years. PMA approval times have recently improved.
Shuren and his colleagues at CDRH have travelled the country the past year listening to industry and investor concerns and assured them they are taking their responsibility to promote patient health as seriously as protecting the public.
In addition to seeking out collaborations with industry, the agency announced in January 2011, a Plan of Action that included 25 specific actions CDRH would take to improve the predictability, consistency, and transparency of the pre-market review programs. As of October 2011, FDA had started implementing 17 of the 25 actions and had committed to begin implementing all 25 by the first half of 2012.
Furthermore, the agency and medical device industry representatives are currently negotiating the reauthorization of the Medical Device User Fee Act (MDUFA) which is scheduled to expire at the end of September 2012. MDUFA sets performance goals for device review times as well as the fees paid by industry device submissions.
Industry Assistance
Shaye Mandle, LifeScience Alley’s VP for government relations told OTW that inherent within the strategy of better collaboration between the agency and industry is the further development of tools and methods utilized by the FDA to evaluate and approve new technologies—“regulatory science.”
“As the clear innovators of new technologies, industry provides critical scientific and intellectual knowledge to the FDA in the development and implementation of this strategy. Further, collaboration can improve consistency, create shared expectations and eliminate or reduce unpredictability in the submission and approval process, ” said Mandle.
Streamlining Submission Process
Mandle expects that these scientific collaborations will produce models to speed the process of submission. “If the FDA approves a model for testing and industry uses that model to validate its data, the approval process becomes streamlined.”
For example, Mandle says that if the FDA had a set of approved/accepted models for measuring replacement hip debris that all of industry could utilize, that might speed the approval process. “This is a possible opportunity that the partnership might undertake, ” said Mandle.
Changing the Tone
Perhaps more important than the nuts and bolts of a highly structure collaboration, said Mandle, is an attempt to change the tenor of the current debate and “detoxify” the relationship between industry and the FDA.
He said the current public rhetoric has turned into a blame game between industry and the FDA over the regulatory environment. By creating a conversation outside of the political arena, driven by science and technology, Mandle believes substantive strides in improving understanding between the FDA and industry can improve their relationship and interactions.
A new tone of collaboration between industry and regulators in 2012 is a good sign that may speed up the process of getting safe and effective new devices and treatments to patients in America.
