It is essential to FDA’s proper functioning that stakeholders have a viable appeals process. This means a process that is timely, transparent, and fair. A viable appeals process is an essential “check and balance” to limit arbitrary and capricious decision making, to correct erroneous decisions, and to maintain consistency in decisions.
As discussed in a prior blog post, in the medical device arena, the appeals process is not functioning well, and is in urgent need of reform. Over the years, the statute and regulations have become encrusted with a multitude of overlapping procedures that are so expensive and time consuming, that they are practically useless. At the same time, the most viable procedure, a request for supervisory review under 21 C.F.R. § 10.75, has not functioned well, at least in recent years.
Late last month, the Center for Devices and Radiological Health ("CDRH") issued a draft guidance document on “CDRH Appeals Processes.” The guidance provides general information about the various appeals processes available to individuals “who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered.” This guidance, if finalized, would replace a 1998 guidance document about medical device appeals and the 2001 guidance describing the Dispute Resolution Panel.
The new draft guidance does a good job of explaining all of the various complicated appeals processes that are available. The 1998 guidance presented the types of decisions that might be appealed and provided guidance on the various processes available for each type of decision. The new guidance focuses instead on explaining the appeal procedures, i.e., request for supervisory review, Medical Devices Dispute Resolution Panel ("MDDRP"), the various types of petitions, the various types of hearings, and judicial review. This approach seems to make the material more understandable.
The 1998 appeals guidance did have a useful set of tables with the essentials of each procedure and the “pros” and “cons” of each. These are unfortunately omitted from the new draft guidance. It would be helpful to retain them, perhaps in an appendix.
Perhaps the most welcome aspect of the new draft guidance is the detailed description of the supervisory review process. In most cases, this type of appeal is the only one that is practical. Until now, however, there has been very little written by FDA about how it works, other than the bare bones of the regulation itself (i.e., 21 C.F.R. § 10.75) and a fairly cursory description in the 1998 appeals guidance. The new draft guidance removes some of the mystery about the workings of this procedure.
The draft guidance appears intended to be descriptive of the existing procedures and not to introduce reforms. At the same time, there do seem to be some new wrinkles, although they are not labeled as such.
First, the draft guidance does set out written time frames for review that, if followed, could significantly reduce industry frustration with the process. For instance, the draft guidance states that a review meeting or teleconference will be scheduled within four to six weeks of receipt a request for such review, and a decision on the appeal will be communicated within six weeks of submission of the written appeal or appeal meeting. These time frames are consistent with oral targets that CDRH officials have conveyed over the years, but they generally have not been followed. It is unclear if putting these time frames in writing will lead CDRH to adhere to them more consistently. If not, it would be more useful to sponsors for CDRH to provide actual timeframes, rather than aspirational timeframes to which CDRH will not be able to adhere.
Second, the new draft guidance specifically states that sponsors may appeal decisions that are not final. Though the 1998 guidance stated that a 10.75 appeal may be appropriate for appealing requests for additional information, the new draft guidance states that 10.75 review may be available for disputes involving a pre-IDE submission, Warning Letter, and request for additional information associated with an adverse event report. The draft guidance notes that most of these appeals for “intermediate” decisions would be “paper appeals,” meaning that, barring exceptional circumstances, there would be no teleconference or in-person meeting. The draft guidance states that this paper appeal process for intermediate decisions will help “streamline” the process for these reviews. What the new draft guidance does not address, however, is how these types of “intermediate” decisions (of which there may be many) can be reviewed in a manner that will not significantly affect the timeframe for review of “final” decisions, e.g., an NSE or PMA denial.
Third, the draft guidance introduces the concept of “telescoping” the review process, meaning that, in “certain unusual circumstances,” a supervisor may discuss the issues on appeal “with individuals at a higher organizational level.” Circumstances for which this may be appropriate include matters pertaining to regulatory issues, new policy questions, or highly complex scientific questions. In some cases, these circumstances “may also warrant referral of the review directly to the next-level supervisor, up to and including the Center Director,” in which case the review “will be considered to have been undertaken by the next-level supervisor.” The decision to telescope a review may be undertaken solely by CDRH, and CDRH will document the rationale for such a decision in the appeal decision letter.
Fourth, the draft guidance states that in “matters that are particularly complex or novel, the submitter may request that the review authority refer the dispute to an Advisory Panel to make a recommendation to the review authority” or may “request that the review authority consider referring the matter to one or more external Subject Matter Experts.” To our knowledge, such use of external expertise has not previously been available under section 10.75. While the submitter may request use of external expertise, CDRH drafts the document to be provided to the external expert “that states the issue(s) in dispute and includes relevant documents for review.” In order to ensure that the external expert receives a summary reflective of both FDA’s and the submitter’s perspective on the issues, we believe both parties should have the opportunity to provide information to the expert.
Fifth, both the 1998 guidance and the new draft guidance state that the appeal may not include any new information and may be based only on information already contained within the administrative record. The new draft guidance states that a submitter “can add graphs, simple analyses, or other minor clarifications,” but may not add “additional data that has not been previously reviewed, or substantially different analyses of existing data.” In certain circumstances, this prohibition against new information may present an issue of fairness. For instance, a submitter may have data that would respond to an issue raised in an NSE letter, but the submitter may not have previously submitted the data because CDRH had not raised the issue. The submitter should not be prohibited from presenting that data in an appeal to support its position that the NSE letter was issued in error.
In our view, the draft guidance is helpful. At the same time, actual reform of the appeal process is badly needed. As discussed in more detail in a prior blog post, the creation of an Office of Appeals might facilitate fairer, prompter and more consistent handling of appeals. This could be done through guidance if it is a voluntary alternative to a traditional supervisory review. If successful, the project could be made mandatory by notice and comment revision of 21 C.F.R. § 10.75.
Ultimately, a thoroughgoing rationalization and reform is needed of all the relevant statutes and regulations relating to the appeals process. This overhaul would require congressional action, and is not likely to happen any time soon. In the meantime, if FDA could adhere strictly to the time frames for supervisory review set forth in the draft guidance, that would be a significant step forward.
It would also be helpful if FDA could begin to publish annual metrics revealing how they are handling appeals. For instance, FDA should at least disclose figures on how many appeals are initiated each year, their disposition (i.e., whether the original decision was affirmed, reversed, or modified), and the median time to completion. This kind of information would help industry better understand the appeals process and also could be used to formulate an intelligent reform agenda.