The FDA posted a draft guidance in August dealing with certificates for export of medical devices, a move prompted by the Food and Drug Administration Reauthorization Act, but the response from industry and regulatory attorneys was anything but favorable. Among the complaints about the draft is that it collides with how the FDA typically handles a device maker’s proposed corrections, but others said the draft does not comply with the statute.
The draft deals with how device makers can revive a request for a certificate for export after a difficult inspection, and one of the responders, Stacey Backlund of BTG International in Philadelphia, pointed out that denials of certificate for export are not in the class of significant regulatory decisions. Consequently, these are not subject to the 30-day time limits for filing and review of petitions, but Backlund was hardly the only regulatory consultant to make the point.
Allyson Mullen of Hyman, Phelps and McNamara made the same point about 30-day turnarounds in her comments to the docket, but Mullen also said that the agency’s response to a proposed set of corrections after an inspection is often dead silence, which leaves the device maker in a nearly insoluble predicament. The Advanced Medical Technology Association was no fan of the draft, either, arguing that the FDA went beyond the language in FDARA in that the draft required that the agency accept a proposed set of corrections as adequate. AdvaMed’s Steve Silverman said such an expectation is implausible if only because corrective actions tend to morph over time.
Silverman went on to note that the draft excludes certificates for devices that are manufactured outside the U.S., which he said clashes with the statute as amended by FDARA. Silverman said the statute directs the FDA to handle certificates for export for devices that are manufactured in any establishment in any location, so long as that establishment is registered with the FDA. It is not clear when the agency expects to finalize this guidance, however.
FDA; Clinical Data not so ‘Quik’
The FDA has rolled out a pilot program for the Quality in 510(k) review program, which is known as the Quik 510(k) program, an alternative to the standard 510(k). The agency said this program – which entails a 60-day decision – is not suitable for combination product applications, but also that regulatory filings that require clinical data might not be good candidates for a Quik 510(k), either.
This pilot will not subject applicants to the refuse-to-accept review used on traditional 510(k)s, but sponsors are expected to respond promptly to any requests from the agency for additional information for the application in question. Any applications deemed ineligible by the Office of Device Evaluation will be handled under the normal 90-day review time frame, but this pilot is limited to a relatively small number of well-understood devices that appear under 40 product codes. In vitro diagnostics are not part of the pilot, and sponsors must use the electronic filing mechanisms in order to qualify.
Third Parties Still an Issue in MDLs
For those in the life sciences, multi-district litigation has proven to be a complex and unruly process, but one of the more prominent issues is that of third-party funding for litigation. This is nothing new, as third-party litigation funding was the subject of concern at least as far back as 2014, but this and several other issues are of concern to attorneys who defend drug and device manufacturers.
Lawyers for Civil Justice was one of several organizations that urged the Advisory Committee on Civil Rules to require disclosure of third-party funding in 2014, but Alex Dahl of the Strategic Policy Council said on a recent webinar that the presence of third parties in multi-district litigation is still not routinely disclosed to defendants. There are a number of other issues that plague the MDL system as well, such as a lack of vetting of individual cases, and by some accounts, between 30 and 50 percent of the individual claims in MDLs are nothing more than junk claims.
The question of third parties was on tap at both the November 2017 and April 2018 meetings of the Civil Rules Advisory Committee, which included an extensive discussion of this and other issues. The committee formed a subcommittee to examine the third party problem, but it is not clear where the subcommittee might land on this and several other issues with MDLs, including the problem of prospectively identifying which complaints in an MDL are without merit. Still, there is at least one district court, the Northern District of California, which has a standing order mandating disclosure of third parties, seemingly setting a precedent for the subcommittee to act.