FDA-VA Memorandum of Understanding Will Not Appease Critics

by: Fredric Cohen, M.D.

FDA and the U.S. Veterans Administration [VA] announced signing a Memorandum of Understanding (MOU 225-07-4300) that would enable the agencies to share information for the main purpose of: “build[ing] infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices.”

The MOU is far too wishy-washy to satisfy me, let alone Congressional critics of FDA’s drug safety oversight policies. Consider Item 3(d) of the MOU, which reads more like a guideline for avoiding progress than achieving it:

3d. FDA and VHA agree that either may decide not to share information or expertise in response to a particular request for information made according to the procedures established under Section 3.b., or to limit the scope of information and expertise sharing in response to a particular request. A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding Federal partner’s priorities, or legal restrictions. In the event both partners can not reach consensus on a decision to share or not share information, the issue will be referred to the FDA Deputy Commissioner for Operations and the VHA Under Secretary for Health for a final decision.

Federal agencies like the VA and CMS (Medicare/Medicaid) are responsible for acquiring and maintaining a treasure trove of therapy utilization and medical claims data. Getting at these data in a way that is useful for monitoring the safety of therapeutics by FDA should be a cornerstone of any national therapeutics safety-monitoring policy.

What is needed is a genuine alliance between these federal agencies, formed by a dedicated group of experts who have dedicated resources to support them, and is led by an upper-level management committee whose main role is to ensure continued support of the agencies and Congress. A promise for agency liaisons to hold quarterly meetings and for the parties to respond to specific requests for information (as opposed to a provision for open information exchanges) is not nearly good enough.

It increasingly looks like Congress is going to have to legislate a mechanism for sharing data that holds individuals responsible and accountable for making progress. It’s clear from the language in this MOU that Congress must also make such data sharing a priority of all involved agencies, and that it must earmark funds to support it.