CDRH Working to Update Appeals Guidance for Consistency with FDASIA

By Jeffrey K. Shapiro & Jennifer D. Newberger –

The medical device appeals process has long been in need of improvement.  See our previous posts here and here.  There are several ways an entity can appeal a decision of the Center for Devices and Radiological Health (“CDRH”), but the most common of these is by “supervisory review,” described in 21 C.F.R. § 10.75.  This allows an appeal to the next level supervisor above the individual who signed the decision.  FDA historically has taken a long time to make its appeal decision, and industry also has had to appeal from cryptic written decisions that made it difficult to understand the basis for the adverse decision.  In December 2011, FDA issued a draft medical device appeals guidance with voluntarily adopted target deadlines for an appeal decision to be communicated within six weeks of submission of the written appeal or appeal meeting.

A few months later, Congress included a device appeals provision, Section 603, in the recently enacted Food and Drug Administration Safety and Innovation Act (“FDASIA”).  This provision imposed a 45 day deadline for FDA to decide an appeal (or 30 days from a requested appeal meeting).  Section 603 also requires FDA to issue a “substantive summary” explaining the basis for the adverse decision.  The latter requirement is intended to assist industry in understanding the basis for adverse decisions. 

We recently contacted knowledgeable officials at CDRH to help us better understand interpretational issues that have arisen around Section 603.  We were also curious as to how FDASIA would affect the draft guidance.  We were told that CDRH intends to issue final updated guidance, which will address FDASIA, perhaps as early as July 2013.  We summarize below what we learned.

1.    FDASIA § 603, enacted as section 517A of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), applies only to appeals of “significant decisions,” but does not define that phrase.  CDRH is currently working on a definition of this term to be provided in the forthcoming updated guidance.  It is our understanding that CDRH’s interpretation may be published in draft, either as a draft addendum to the final guidance or a separate document, providing stakeholders with an opportunity to comment prior to final issuance.

2.    FDC Act § 517A(b)(2) states that a person requesting supervisory review of a significant decision must submit the request for review within 30 days after the date of the decision in dispute.  The guidance will likely reflect CDRH’s interpretation that this provision means a firm that fails to appeal within 30 days loses all right to a supervisory appeal.  The firm could not fall back to the old non FDASIA request for supervisory review under 21 C.F.R. § 10.75, which does not impose a deadline for filing.  Also, CDRH apparently interprets the FDASIA language as not allowing for waivers, placeholders, or “partial submissions.”  They view the 30 day time limit as a “hard cap.”  The bottom line is that a request for supervisory review must be filed in 30 days, in full, or that option will likely be lost forever.  (A disappointed applicant could still invoke other appeal procedures.  For instance, a citizen petition could be filed under 21 C.F.R. § 10.30.  But that is a public proceeding and FDA could take years to respond, making it unrealistic in most cases.)

3.    One might think that the hard 30 day deadline applies only to appeals of significant decisions, which are the focus of the new FDASIA appeal procedure deadlines.  However, CDRH is considering whether to apply it to non significant decisions as well.  (It is unclear to us what the legal basis would be.)  If CDRH does apply the 30 day appeal deadline to non significant decisions, they would probably also honor the response deadlines in FDASIA as a sweetener.  It is also possible that CDRH will allow an appeal of a non significant decision to be submitted within a longer time frame and, unlike the appeal of a significant decision, may allow a stakeholder to request an extension.

4.    FDC Act § 517A(a)(1) requires FDA to provide to the submitter a “substantive summary of the scientific and regulatory rationale” underlying the significant decision.  The summary must include “documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.”  Presumably, an applicant would seek this information to assist in preparing an appeal of the “significant decision.”  The law, however, does not set a time frame within which a request for a substantive summary must be submitted and does not impose a deadline on FDA as to when it must issue the substantive summary.  CDRH is trying to determine when the substantive summary will be provided, what it will include, and if there is a way to work development of the summary into the reviewers’ workflow to make it easier to provide in a timely manner.  These issues will be addressed in the updated appeals guidance.  We were told, however, that there is no guarantee that the guidance will require CDRH to provide these summaries before the 30 day deadline to appeal the decision.

We will follow up with any additional information as it becomes available.