With the recent inking of a Memorandum of Understanding (“MOU”) between the Centers for Medicare & Medicaid Services (“CMS”) and the Food and Drug Administration (“FDA”) concerning sharing information and expertise, these two agencies are inching toward parallel reviews for marketing approval and Medicare coverage.
Although released in early July, the MOU (MOU 225-10--0010) became effective on June 25, 2010. Dr. Jeffrey Shuren (Director, Center for Devices & Radiological Health) announced that the MOU will allow routine and timely sharing of information and expertise between the FDA and CMS. While the goal of this inter-agency information sharing may be to create a mechanism which permits Medicare payment and coverage determinations by CMS and pre-market review by the FDA to occur concurrently, Dr. Shuren made clear in his announcement that these activities would occur at manufacturer’s request.
While the FDA and CMS may be on a course toward parallel reviews, the MOU does not address these activities directly and provides a general framework for the two agencies to “work together to promote initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements.” In addition to enhancing information sharing through more efficient and robust activities, the MOU goals include promoting efficient utilization of tools and expertise for product analysis, validation, and risk identification and building an infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.
Representatives of CMS and the FDA will meet this summer to establish specific procedures and safeguards which are necessary to implement the MOU and then periodically on an as-needed basis thereafter. “Unless and until adequate procedures and safeguards are established and implemented,” the two agencies have agreed not to share information under the MOU.
From industry’s perspective, the MOU identifies several important guidelines or requirements for the way in which the information sharing procedures will operate:
- Each agency will appoint a single contact person who will be responsible for facilitating activities under the MOU. The point of contact will receive and act on the other agency’s initial request for information; however, assuming agreement to share the requested information, subsequent communications regarding the issue may occur at the staff level.
- In response to a particular request, each agency may decide not to share information or expertise or to limit the scope of a particular request for information and expertise. The basis for denying a request includes reasonableness of the request, the amount of resources required to perform the request, the responding agency’s priorities, and legal restrictions. If the two agencies cannot agree on a decision to share or not to share information, senior officials at each agency will reach a final decision.
- Certain types of information must be protected from unauthorized disclosure. These include (i) trade secrets and other confidential commercial information and personal privacy information that would be protected under a specific Freedom of Information Act (“FIOA”) exemptions and (ii) information that otherwise would be protected under the federal Trade Secret Act, Privacy Act, Food, Drug, and Cosmetic Act, FIOA, and HIPAA and related rules and regulations.
- Each agency must notify the other of any actual or suspected unauthorized disclosure of shared information. If a third party’s confidential information is shared and then improperly disclosed, there is no additional requirement that the originating agency that shared the confidential information give the third party notice of the unauthorized disclosure. Third parties appear to be left to the reporting or notice requirements imposed under statutes or regulations; the MOU does not address this.
- As part of the MOU implementation, CMS and the FDA must adopt “proper safeguards against unauthorized use and disclosure of the shared information”, including policies and procedures to ensure that the information will be used “solely in accordance with” specific federal statutes and related regulations. These include the federal Trade Secrets Act, Privacy Act, Food, Drug, and Cosmetics Act, and FIOA, as well as HIPAA. The MOU also requires CMS and the FDA to establish “appropriate administrative, technical, procedural, and physical safeguards” to protect confidentiality and prevent unauthorized access.
- Each agency can allow access to the shared information only to its employees, agents, and officials “who require access to perform their official duties” in accordance with the shared information uses outlined in the MOU. CMS and the FDA also must advise these individuals of (i) the confidential nature of the shared information, (ii) the safeguards required to protect the shared information, and (iii) the administrative, civil, and criminal penalties for non-compliance.
- Any FOIA request will be referred to the originating agency which provided the shared information and the requestor will be notified of the referral and that the originating agency will provide the response.
The MOU also contains restrictions regarding the use of the shared information, including:
- The shared information may be used “solely for the purposes outlined in the MOU.” However, if a requesting agency seeks another use or purpose, this additional use must be submitted to the originating agency in writing, and the originating agency will determine whether or not the requested use is acceptable.
- The FDA’s and CMS’ actions under the MOU must be consistent with existing laws and regulations.
- Nothing in the MOU is to be construed as changing the current requirements and regulations which are administered or enforced by CMS or the FDA (including the federal Food, Drug, and Cosmetics Act and the Public Health Service Act) or is to be a mandate or requirement imposed on either the FDA or CMS that is in addition to those imposed by existing law.
For those who are concerned that this inter-agency information sharing will result in the respective agencies’ determination of national cover age for a product (in the case of CMS) and a product’s pre-market review (in the case of the FDA) influencing the other, these reminders that the well-developed jurisdictions of the FDA and of CMS are to remain intact and are not be eroded may not be sufficient. The test, of course, is the implementation of the MOU and actual information sharing activities.
While manufacturer’s and their investors may want to reduce the time between FDA market approval and CMS approval for national payment, there is potential downside to the supposed efficiencies of a parallel review process. CMS and the FDA historically have had different missions and different perspectives; it is appropriate to co-mingle these? What do third parties risk if their proprietary information is shared with CMS, an agency without a statutory requirement to safeguard third party proprietary information (or, arguably, related cultural imperative to do so)?
Will the FDA’s use of CMS’ post-market information for products become an accurate and efficient method to speed along the FDA review? Will FDA decisions be made with adequate clinical data to support a CMS determination of national coverage? Do manufacturers and sponsors want to run the risk that the FDA and CMS may collect and interpret seemingly useful information differently and that these differences may result in delays necessitated by required corrections or reinterpretations, as well as unanticipated costs? Will reimbursement planning become a required element for market clearance so that post approval clinical data is no longer essential for reimbursement decision making? Will these concerns, and others, make manufacturers and sponsors think twice before applauding this information sharing initiative or agreeing that their confidential information can or should be shared?
Given the possibility (or reality) that CMS’ reimbursement concerns may become an element in the FDA’s determination of the product’s safety and market clearance and that implementation of the shared information activities undoubtedly will have some unexpected and unintended consequences, industry members may be pleased that currently the FDA and CMS are moving slowly along a path toward parallel review. And, because of the uncharted details in this arena, they may welcome Dr. Jeffrey Shuren’s recent statement to the effect that “parallel review is not a done deal” and the opportunity to monitor the development of parallel review procedures.
