A Difference of Opinion: CDRH’s SOP for Internal Supervisory Appeals

October 8, 2012

By Jeffrey K. ShapiroJessica A. Ritsick

Under FDA’s regulations (10 C.F.R. § 10.75), the decision of an FDA employee (other than the Commissioner) is subject to supervisory review in four circumstances: (1) when an employee so requests; (2) when a supervisor initiates review; (3) when an interested person outside the agency so requests; and (4) when delegations of authority so require.  Id. § 10.75(a)(1)-(4).  Those in industry know, of course, that appeals can be triggered by interested persons outside the agency (circumstance #3, above).  But there also can be appeals pursuant to an employee’s request (circumstance #1, above). 

On September 4, 2012, CDRH released internal Standard Operating Procedures ("SOP"), titled "Resolution of Internal Differences of Opinion in Regulatory Decision-Making," to explain how to resolve internal differences of opinion in making regulatory decisions, implementing 21 CFR § 10.75 “for internal review of CDRH decisions, as it applies to supervisory review of regulatory decisions on the initiative of Center employees in the process of reaching those decisions.” 

One can imagine such appeals occurring in a situation where an employee vehemently disagrees with a decision either favorable or unfavorable to a firm.  Thus, those in industry do have some stake in the procedure governing FDA internal appeals. 

Interestingly, the SOP permits an employee to approach CDRH’s Ombudsman to discuss the situation if the employee is uncomfortable with approaching management.  The SOP gives the Ombudsman three additional duties: (1) reviewing the dispute (called the “Initiation Memo”), and determining if the dispute moves up the chain to higher management or if it is dead in the water; (2) suggesting alternative ways to resolve the dispute beyond the formal SOP procedures; and (3) if he sees fit, activating accelerated dispute review when an initiator believes the dispute “may have a significant and immediate impact on the public health.”  None of these duties are in his job description, at least according to FDA’s website, which says the Ombudsman’s duty is to investigate “complaints from outside FDA and [facilitate] the resolution of disputes between CDRH and the industry it regulates” (emphasis added).  On the other hand, making use of the Ombudsman in sensitive internal disputes does likely fall within the Ombudsman’s core competency.

Also interesting in the SOP is its allowance for use of outside experts in resolving disputes.  “Reference to outside expertise may consist of an advisory panel meeting or a homework assignment to selected Special Government Employees (SGEs) with relevant expertise.”  This use of outside experts could potentially conflict with 21 CFR § 10.75(d), which states:  “Internal agency review of a decision must be based on the information in the administrative file.  If an interested person presents new information not in the file, the matter will be returned to the appropriate lower level in the agency for reevaluation based on the new information.”  Thus, it would seem possible that bringing in an outside expert to lend his or her expertise to resolve a dispute—a dispute of scientific, clinical, or regulatory opinion—would be “new information not in the file,” such that the issue should be bumped back down the chain and reevaluated, as opposed to the up-the-chain review prescribed in the SOP. 

FDA might argue that “interested person” refers to an interested person “outside the agency” and that the requirement does not apply to internal employee appeals.  However, the phrase “interested person outside the agency” appears elsewhere in this short supervisory appeals regulation, but not here.  Thus, it could be argued that FDA knew how to specify whether an interested person was within or outside the agency, and in this case, did not limit the “no new information” requirement to persons outside the agency.

Categories: Medical Devices