DoJ Revisits Standard for Qui Tam Dismissal

The Department of Justice has released a new memo addressing the standard for dismissal of relator lawsuits under the False Claims Act, and both the content and the tone of the memo are starkly different from what might have been expected under previous administrations. Precisely how this memo will change routine practice is “difficult to predict,” as the saying goes, but the memo is at the very least a suggestion that some of the less credible qui tam suits will have a very short shelf life, indeed.

Resources an Issue for DoJ                                                             

The DoJ memo says the annual total of qui tam actions has neared or exceeded 600 new matters in each of the past several years, a disclosure that might surprise no one, given the related provisions of the Affordable Care Act. However, the rate of federal interventions “has remained relatively static,” the memo stated, although the department must nonetheless expend resources to monitor cases in which the government ultimately does not intervene.

One might impute a number of motives for the memo overall, but one thing is clear: DoJ is seeking to economize when it comes to dealing with relator lawsuits, as demonstrated by the passage directing the reader’s attention to “the government’s limited resources.”

The memo points out that the department can dismiss an action over the relator’s objections, although that relator may be entitled to an appeal of that decision. DoJ lists seven factors that seem to have driven dismissals since 1986, including the curbing of meritless cases and prevention of relators who seek to piggyback onto an ongoing government investigation. Another factor would be whether the federal agency affected by the action expects the case to interfere with the policies and programs of that agency.

Standard for Dismissal Clarified

In addition to the factors cited above, the memo states that dismissal is an option to address a case pockmarked with “egregious procedural errors,” citing the case of Surdovel v. Digirad Imaging as an instance. This case was dismissed in 2013 after government attorneys determined that the relator had “failed to serve the United States with the complaint and disclosure of all material facts.” However, the memo indicated that federal attorneys should feel free to leverage both the unfettered discretion and the rational basis standards for dismissal.

As might be expected, the D.C. District Court is one jurisdiction where the unfettered discretion standard is at work, although the Ninth and Tenth Circuits have made use of the rational basis test. The memo argues that even the rational basis standard “was intended to be a highly deferential” standard, and the memo advises a federal attorney to notify the court as to the basis for a motion to dismiss in jurisdictions where a standard has not been identified.

The memo offers some tactical advice, suggesting for instance that prosecutors separately assert any alternative grounds for seeking dismissal, citing the bars on public disclosure and pro se relators as examples. This approach provides independent legal bases for dismissal, but partial dismissal is another tactic available to federal attorneys.

Interestingly, the memo concludes with language suggestive of a view that the rate of meritless qui tam actions is on the rise, stating that relators have dismissed more than 700 actions since the beginning of 2012 when the department declined to participate. This more routine withdrawal of a qui tam, the memo states, “has significantly reduced the number of cases where the government might otherwise have considered seeking dismissal.”

Auld Acquaintance; 2017 Guidances and 2018 Enforcement

2017 is now a part of the past, and everyone has their own idea as to which were the most crucial developments of the year. Following is a nomination for two FDA guidances that are at least strong candidates for the title of the most important guidances of 2017, along with developments in two ongoing dramas that could prove pivotal in this new year.

What’s Old is New (yet) Again

The FDA’s Center for Devices and Radiological Health had little to offer in the way of guidances in the first half of 2017, but the center made up for that in a big way in the latter part of the year. CDRH issued 19 draft and final guidances in the last three months of the year, but the month of September was a busy one, too.

Still, the most important guidances might not have been the most widely discussed. The October final guidance for 510(k) changes and the companion software 510(k) changes final guidance might not have the splash value of the agency’s moves in the digital health realm, but it’s easy to forget how long the 510(k) changes controversy has strained relations between the FDA and industry.

Thinking back to the legacy K97 guidance of 1997, this discussion has been the subject of formal regulatory interest for only 20 years despite that the Medical Device Amendments were added to the statute more than 40 years ago. The agency took a stab at rewriting K97 in 2011, but that attempt proved futile thanks to the opposition it triggered.

Traditionally, the estimates of the number of 510(k) clearances each year is somewhere between 3,500 and 4,000, a much greater number than the volume of original PMAs, which hasn’t hit 100 in recent memory, if ever. Are digital health guidances “hotter” in terms of novelty and hence media coverage?

Apparently, but make no mistake: The 510(k) program and the agency’s overarching administration thereof is easily the most important regulatory development in calendar year 2017, particularly given that the new med tech regulations in Europe could drive a lot of traffic back to American shores.

2018: Commercial Speech Comes of Age?

2017 was a regulatory banner year for med tech, thanks to the 21st Century Cures Act and the provisions of the fourth device user fee agreement, so it’s difficult to see how 2018 can measure up. Still, this new year has at least one blockbuster story in store if recent remarks by FDA commissioner Scott Gottlieb are any indication.

Gottlieb said the agency needs “a legally enforceable set of rules” where commercial speech is concerned, a nod to recent court losses, such as Caronia. Hence, Gottlieb’s said the FDA “can’t be operating from a platform where our regulations might be perpetually in conflict with the courts.”

The agency’s January 2017 draft guidance for payer communications is still in draft form, but that’s to be expected with the change in the commissioner’s office, particularly a commissioner with Gottlieb’s views on the commercial speech question. Another consideration is that a payer communication framework might be the lowest hanging of the several commercial speech questions, and there was little indication at the time that the FDA had adopted a less restrictive approach to off-label communications to physicians.

Gottlieb’s comments from September 2017 suggest he wants the agency to provide industry with some rules of the road for the entirety of the commercial speech problem, but the agency’s chief counsel, Rebecca Wood, avoided the subject in her prepared remarks to a gathering of the Food and Drug Law Institute in early December 2017. The net effect is something of a black box inside which the regulatory version of Schrödinger’s cat awaits our collective scrutiny, but Gottlieb seems determined to settle this matter by one means or another, even if there is some understandable skepticism as to the durability of any resolution. This is a matter worth watching as we move into 2018.

Yates Memo; Up for Grabs?

On the other hand, those who are concerned about a hangover from the Yates memo might be encouraged by the fact that FDA’s Woods conceded that it is time for the FDA to revisit the question of vicarious criminal liability in Park doctrine cases. The question here is whether the agency and the Department of Justice are on the same page, given that these two parties have not necessarily agreed on these issues in the past.

The corporate liability question seems ripe for review if only because Sally Quillian Yates is no longer at the Department of Justice, but deputy attorney general Rod Rosenstein acknowledged that the Yates memo is under review in a speech to the Heritage Foundation in September 2017. Although he offered no details other than to affirm that prosecution of individuals is still seen as important as a deterrent, he stated, “I do anticipate that we may in the near future make an announcement about what changes we are going to make to corporate fraud principles.”

Rosenstein confirmed in an October 2017 speech to New York University that the memo is still in play, explaining that any changes “will reflect our resolve to hold individuals accountable for corporate wrongdoing.” However, Rosenstein also said federal attorneys will not be permitted to “use criminal authority unfairly to extract civil payments.”

While there are few tea leaves to work with, the statement about the use of criminal authority to extract civil payments is at the very least some indicator as to where DoJ may be headed. On the other hand, there are those who worry that the prison sentences handed down in the case of Jack De Coster and Peter De Coster could be part of an emerging pattern despite that the De Costers’ egg businesses routinely and egregiously ran afoul of the law over a period of decades. The corporate prosecution story is clearly another story worth tracking as we work through this new year.

Digital Desires; the FDA’s December Guidance Trove

The end of the year is a time for reflection and maybe even gratitude, but as we can all testify, holiday shopping can be an irritating experience. The FDA got an early start on its holiday shopping list in the first week of December with the publication of several guidances as part of the overhaul of its approach to digital health. As might be expected, though, the experience is a decidedly mixed bag of items, one of which seems likely to be returned for exchange.

SaMD Final: A Leaner, Nicer Approach

On the positive side, the final guidance for software as a medical device (SaMD), the draft of which was written by the International Medical Device Regulators Forum, eliminates some of the seemingly compulsory tone of the draft. Nonetheless, the FDA went to some lengths to emphasize in the final that industry should not read too much into the use of words such as “requirements,” explaining that related provisions fall into the category of recommendations. Given the recent congressional emphasis on the least burdensome standard, the agency perhaps had little choice but to make such a conciliatory gesture.

The final SaMD guidance is 15 pages leaner than the draft (30 pages rather than 45), and large portions of the draft have either slimmed down or disappeared entirely. Definitions have become less descriptive, thus lending an unmistakable air of flexibility to the document. Whereas the draft commits page after page to discussions of generating evidence for scientific and analytical validity, the final guidance offers mere paragraphs for considerations such as analytical and technical validation.

The net effect is that of a high-level document that avoids the quagmire associated with the fine details of product development and testing. Whether this is the last word for some time on SaMD is difficult to forecast, but the reader will note that the agency took the unusual step of announcing the final guidance in the Federal Register, complete with the associated docket number.

The Risk of Saying Nothing About Risk

Conversely, the draft guidance for clinical decision support (CDS) systems presents the reader with a decidedly different dilemma, although it offers some useful content. The draft includes a section spelling out instances in which a CDS would not fall under FDA regulations, such as software that provides recommendations as to the use of a drug within the labeled indication. This document also provides a number of examples of uses of a CDS that would qualify the item as a device, but Bradley Merrill Thompson of Epstein Becker Green had a few choice words regarding the draft.

Thompson, who serves as the general counsel for the CDS Coalition, said the CDS draft lacks clarity on the point of how a vendor might determine how the risks associated with that product’s use might push the CDS into the agency’s regulatory territory. Thompson said this is particularly problematic given the recent and coming advances in artificial intelligence, although others indicated some relief that patient use of CDS was written into the document.

One way of looking at the risk question in this guidance – or more properly, the failure of the draft to directly address the risk question – is that the agency believes it might be a more economical use of its time to draw feedback from stakeholders before committing anything to ink. The docket is open for only sixty days, however, and it seems fairly plausible that the Feb. 6, 2018 deadline for comment will be extended if indeed the FDA intends to provide at least some discussion of risk. After all, the agency’s device center has expended a considerable amount of effort to talk about benefits and risks, including the final guidance on how the FDA will handle the hazards of dealing with problematic devices that may or may not warrant withdrawal.

The last of the three guidances released by the FDA on Dec. 7 was the draft guidance dealing with policy changes to four existing guidances, including the guidance for medical device data systems (MDDS). The agency’s proposal to regulate such software in 2011 sparked a lot of pushback from stakeholders with a lot of bandwidth on Capitol Hill, and the agency walked back from several major features of its early proposals several years ago. This guidance will be substantially revamped, although in its current form it is apparently not operational, as the saying goes.

The general wellness app guidance is also scheduled for a thorough rewrite, as are the guidances for mobile medical applications and off-the-shelf software used in medical devices. Device makers have the 21st Century Cures Act to thank for much of this, but the agency’s latest commissioner, Scott Gottlieb, might have pushed for many of these changes even without the help of the Cures Act. All in all, Dec. 7 was not a bad start to the holiday season, even if one or two items will eventually be re-gifted to the giver.

DTC Gene Tests, Tax Reform in the News

2017 is starting to wind down as evidenced by the resurgence of holiday-themed music and Christmas jingle-riddled television commercials, but Washington is nonetheless making good use of these last few weeks of the year. In one of the more significant regulatory concessions in recent memory, the FDA said it will use a more streamlined approach to direct-to-consumer genetic tests, but the current state of tax reform seems headed for game-stopping controversy unless significant concessions are made.

‘Precert’ the New Approach to DTC Gene Risk Tests

The notion of pre-certification, or “precert,” has gained a lot of momentum at the FDA this year. First, the FDA said in July it would use a precert program for some moderate-risk digital health applications, and now the agency is making use of that same concept in connection with direct-to-consumer genetic tests that disclose the customer’s risk for diseases. The announcement affirms yet again that the agency has adopted a much less militant approach to its regulation of the life sciences under the new leadership.

Readers will remember the controversy over DTC marketing of such tests shortly after Margaret Hamburg took the commissioner’s chair in 2009, which led to a warning letter to several makers of these DTC genetic propensity tests. The agency wrote a warning letter to 23andMe of Mountain View, Calif., in 2010 about this kind of activity, but even two years ago, the FDA was still trying to keep a lid on such activity as indicated by a Sept. 21, 2015 warning letter to Pathway Genomics Inc. of San Diego for the company’s marketing of its Cancer Intercept test.

FDA commissioner Scott Gottlieb said in a statement that these tests do carry some risk, but he also cited the need to devise a regulatory regime that avoids strangling innovation in technological spaces that move at a more rapid pace than the agency can hope to match. Gottlieb made reference to a de novo filing for the 25-hydroxyvitamin D test system by AB Sciex LLC of Redwood City, Calif., but the FDA also announced it had approved a de novo application by 23andMe for the company’s Personal Genome Service (PGS) test on the same day the agency announced the precert program.

The net effect is certainly a positive change for makers of these tests, but any allegations that a false negative cost a consumer their life will undoubtedly spark a severe case of whiplash, at least on Capitol Hill. The real test in this scenario is how the FDA would respond to such criticism.

Tax Reform Gains Momentum

The push for corporate tax reform is heating up on Capitol Hill, and both the House and the Senate have legislation in the works. While neither proposal seems to include a repeal of the medical device tax, both versions eliminate at least some of the credit for orphan drug development, a move that seems certain to drive resistance among drug makers and patient groups alike.

The House Ways and Means Committee passed its tax reform vote on Nov. 9 in a party-line vote, perhaps a predictor of how this issue will play out on both sides of the Capitol. Section 3401 of the Tax Cuts and Jobs Act of 2017 completely eradicates the tax credit for clinical testing for orphan drugs, which the authors of the legislation say will save the taxpayer roughly $54 billion over 10 years.

The Senate took a less stringent but more convoluted approach, with the net result that drug makers will lose $30 billion in tax credits over 10 years. At least one patient group, the American Cancer Society Cancer Action Network, voiced its opposition to several features of the House bill, stating that the majority of cancer drugs qualify for orphan drug status “at some point in their lifecycle.” The group also said a study conducted in 2015 suggested that elimination of the orphan drug tax credit “would be to decrease orphan drug development by one third.”

The issue of the device tax is not necessarily dead despite the failure of both chambers to include a repeal in their respective bills. Much of the conversation about a device tax repeal seems to revolve around the reauthorization of the Children’s Health Insurance Program, which must be completed by Dec. 31. Ways and Means chairman Kevin Brady lent credence to that expectation, stating recently that temporary relief from the device tax will arrive via an unidentified legislative vehicle “before the end of the year.”

International; A Tangled Time for Devices

Taking any medical product across national borders nearly always presents an interesting dilemma or two, but while it’s sometimes horrible, it’s not always bad. Following is yet another example of the classic good news/bad news conversation, but the implications of each depend on where a device maker is selling its wares … or where it intends to go next.

MHRA Breezy on the Brexit

Device makers want to know how British regulators will manage things after the Brexit is an accomplished fact, but the “when” of the Brexit is still up for grabs. Recent reports suggest that Prime Minister Theresa May has agreed to a Brexit bill of €40 billion, but that figure might not be especially popular in some quarters in London.

By some accounts, the initial offer was roughly half that sum, but the €40 billion figure has nonetheless been making the rounds for several months. Antonio Tajani, President of the European Council, is quoted as having described the €20 billion offer as “peanuts,” but May has her hands full at home with members of Parliament (MPs) who would prefer to just walk away from the European Union and pay nothing for the privilege.

As if all this were not enough, there are new reports that May was “begging for help” with the Brexit in a dinner with the President of the European Commission. The story is all over the European press and does nothing to help May’s hand in dealing with intransigent MPs.

Meanwhile, the Medicines and Health Care Products Regulatory Agency has been busy, issuing a guidance on human factors engineering for devices as the third week of September drew to a close. MHRA followed that in short order with a document dealing with medical device stand-alone software, which includes apps. The MHRA stated in the latter document that its approach is based on the EU standard, Meddev 2.1/6, qualifying the British version as “the U.K.’s interpretation” of the EU guidance.

The details of the guidance are not unimportant, but what the MHRA leadership is clearly conveying is that it intends to run as close to parallel as it can with the EU approach to device regulation, at least so far as circumstances permit.

This might come as nothing new to MHRA watchers who probably noticed the paper the agency published toward the end of August for device regulations generally. That document did little more than spell out the requirements of the European Union’s MDRs, hence the software document reaffirms what was already suspected regarding MHRA’s intentions.

As for the human factors guidance, the document stated that its terms apply only to changes to existing approvals and to new applications, but MHRA advised that post-market surveillance will also be very much on its mind going forward. Among the entities said to have collaborated with the agency on this document is Eucomed, so clearly the agency consulted extensively with industry, particularly given that Smith & Nephew is also listed as a collaborator.

New Delhi’s device dilemma

Speaking of tense international relations, the Advanced Medical Technology Association has petitioned the Office of the U.S. Trade Representative to pull India off the list of nations that enjoy the benefits of the U.S. Generalized System of Preferences (GSP). AdvaMed filed the petition because of a recent string of mandatory price cuts for cardiology and orthopedic devices, but trade talks in Washington this week may include a discussion of that problem.

India’s drug pricing authority had applied a hard cap to prices for drug-eluting stents in February, and since then has moved to cap prices for some orthopedic implants as well. AdvaMed said the hit for coronary artery stents is as much as 85 percent in some instances, while some orthopedic devices would face cuts of 70 percent.

Abbott Vascular had attempted to pull its Xience Alpine stent from India, and initially, the government agreed. Despite that typically such withdrawals entail only a six-month transition, India’s National Pharmaceutical Pricing Authority required that the company keep the device on the market for a year.

As luck would have it, however, NPPA reversed that decision and has advised Abbott that it would have to keep supplies of the Alpine available indefinitely. There has been some indication of flexibility on the part of NPPA, which is said to have informally floated a less strangulating cap on trade margins recently, but AdvaMed seems likely to continue pressing its case. Those who tracked the string of Asian compulsory licensing episodes of the previous decade may see a similarly unfriendly shadow over these markets, particularly given hints that other nations in Asia may follow suit.

The governments of the U.S. and India will meet this week at the Trade Policy Forum in Washington, but it’s not just any meeting of the forum. This is a ministerial-level meeting, so the USTR will have all the brass it needs to make a high-level case that the NPPA’s moves are out of bounds. Device makers would do well to stay tuned to this story.

Of Patents and the Parsing of Words

Makers of FDA-regulated products usually have a lot to keep track of, and the last few weeks are no exception. Recently, the FDA seemed to tell industry, “do as I say, not as I do” in connection with combination product classification, while a federal court breathed new life into a lawsuit that could badly damage a very expensive patent for a cholesterol statin.

FDA; Devices are Drugs, too

Some systems of justice say you are innocent until proven guilty, but the FDA guidance for combination product classification has a different approach, stating that in conceptual terms, “all FDA-regulated medical products meet the definition of a drug.” The passage seems to resurrect industry concerns that the primary mode of action (PMOA) controversy is not over yet after all.

The 21st Century Cures Act purportedly fixed a number of problems with combination products, including the PMOA problem as seen in Section 3038 of the Cures Act. That portion of the legislation stated that the PMOA is “the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.”

Granted that this passage is no novelty where the regulation is concerned, but the inclusion of this language in the statute might be seen as putting the FDA’s Office of Combination Products on notice that would get away with no adventurism on the PMOA question. As is widely known, the FDA has locked horns with industry, in and out of the courts, on a number of occasions over the agency’s product classification process, partly because the agency seemed to develop a penchant for seeing any chemical mode of action at all as necessarily categorizing the product as a drug.

This bias toward categorization  of a combo product as a drug was a significant bone of contention with industry in the 2011 draft guidance for determination of product classification. One of the arguments raised by industry at the time was that the text and the legislative history of the Food, Drug and Cosmetic Act suggested that if anything, the bias should be that a medical product is a device, not a drug. However, the final guidance states, “conceptually, all FDA-regulated medical products” meet the definition of  a drug “due to the broader scope of the drug definition.”

For what it’s worth, the agency addressed the chemical action question a bit more forthrightly than it has in the past, vowing that it will not assume that a product with a chemical action in the body is necessarily a drug, but that passage may prove to be of little consolation when the next inevitable close call shows up at OCP’s doorstep.

Patent Scrum Over PCSK9s Not Over Yet

Amgen v. Sanofi is headed back to a district court after the Court of Appeals for the Federal Circuit overturned a couple of determinations by a district court, and upheld a couple of others. The Federal Circuit lifted an injunction the district court placed on one of these cholesterol statins, but the more interesting matter may be how the Federal Circuit ruled on whether evidence developed after the patent priority date can be used to invalidate a patent.

Amgen’s lawsuit against Sanofi and Regeneron alleged infringement of Amgen’s patents for Repatha, the PCSK9 inhibitor that hit the market a couple of years ago with an eye-popping price tag that had payers in an uproar. Prior to the hearing at the Federal Circuit, the case was heard in a district court in Delaware, where U.S. District Judge Sue Robinson affirmed Amgen’s argument that the patent was not obvious, and ordered the defendants to pull Praluent off the market.

Robinson also excluded evidence about the patents for Repatha that was based on data developed after the patent priority date of January 2008. The question here seems to revolve around whether Amgen was required to characterize all the species of antibodies that bind to the PCSK9 enzyme, a bit of biochemistry that is necessary to achieve the cholesterol-lowering effect of this class of drugs.

Amgen is said to have screened 3,000 species of antibodies to arrive at the two that are used in the drug, but Robinson had ruled that Sanofi and Regeneron could not introduce evidence that the written description for Repatha failed to comport with the statute governing patents. The passage in question, Title 35 of the U.S. Code (§112), states that a patent applicant must characterize the patented item in “full, clear, concise and exact terms,” a standard the sponsors of Praluent said Amgen had failed to fulfill.

Robinson’s rationale was that the evidence offered by Sanofi and Regeneron would not have served to “illuminate” the state of the art at the time of the filing of the Repatha patent, but the Federal Circuit saw otherwise, essentially concluding that the question is not whether the evidence was illuminating, but rather whether Amgen’s written description of these antibodies was sufficient to support a patent.

The Federal Circuit also said Robinson’s instructions to the jury led the jurors to believe that a description of a novel antibody would suffice to cover the requirement that a patent describe a correlation between structure and function. The net effect of all this is that the case will head back to the district court, but a date has not been set, and Robinson is said to have left the court. Her absence will likely be felt, given that TC Heartland v. Kraft will soon load the court with a large volume of cases thanks to that decision’s effect on the long-standing forum question and the presence of a huge number of LLCs in the Blue Hen State.

A Festival of Device Guidances

Now that the first half of 2017 is vanishing in the rear-view mirror, the FDA’s device center has resumed its steady production of draft and final guidances. Thanks to the 21st Century Cures Act and the FDA Reauthorization Act of 2017, there’s much more to come, but regulatory geeks can now celebrate the end of a long guidance drought at the Center for Devices and Radiological Health.

Data Disharmony on Display

Between regulatory harmonization and regulatory convergence, the latter is the less implausible, but the FDA final guidance for demographic representation and reporting in clinical trials does not mesh well with the current state of affairs in the European Union, which may complicate the conduct of multinational clinical studies.

The CDRH final guidance for enrollment and reporting of different demographic groups in clinical studies stems at least in part from congressional mandates, but the statute in several European jurisdictions may complicate the gathering of demographic information for participants in those studies. For instance, Article 8 of the European Data Privacy Directive 95/46/EC states that EU member nations “shall prohibit the processing of personal data revealing racial or ethnic origin” and a number of other pieces of information, including anything pertaining to “health or sex life.”

At least two EU nations, France and Portugal, have similar laws on the books, so it’s not as if the problem can be handled in its entirety in Brussels (although by some accounts, the updated French statute carves out an exception for clinical studies). Because of the congressional mandates, the FDA also has little room to breathe.

Whether the authors of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) realized there was an impasse in the offing for multinational clinical studies is not clear, and it should be noted that the EU directive does not kick in until May 2018. Nonetheless, consent is likely to be more worksome in these instances, particularly since the EU law also addresses de-identified sources of data.

FDA Rejects Five-Year Follow-Up in HPV Final

The term of follow-up is always a bone of contention between the FDA and device makers, but the agency resisted calls from clinicians to tack on a five-year follow-up requirement in the final guidance for diagnostics for the human papillomavirus.

This is a document with some history behind it, including a 2009 draft that drew fire for its insistence that all precision studies be conducted at one site. The final guidance allows a sponsor to use two external and one internal testing sites for reproducibility studies, which typically encompass evaluations of precision.

Perhaps of greater importance is that the final guidance requires that sponsors follow patients for a shorter span of time than was recommended by several professional societies. The American Society of Cytopathology and the College of American Pathologists were among those who urged the agency to require that sponsors follow a subset of women with negative co-testing results for five years, but the agency indicated no interest in such a requirement despite the societies’ argument that this would comport with their guidelines for co-test screening intervals.

In a somewhat related development, CDRH announced in the Sept. 8 issue of the Federal Register that it has scheduled a Jan. 11, 2018, workshop for self-collection devices for pap tests. Clearly the agency’s primary interest is in public health – the agency remarked that there are still gaps in screening for cervical cancer – but the development might also seem to portend a more relaxed approach on the agency’s part to home sample collection going forward. It’s too soon to anticipate where this particular conversation might be headed, but testing labs would probably have to more vigorously demonstrate the reliability of their tests than is currently the case, and designers of collection kits might be charged with usability studies to ensure those kits can be reliably used by those with limited familiarity with such things.

Cosmetic Industry on Oodles Of Needles

Those who are in the business of making microneedling devices for cosmetic purposes might want to take heed of the draft guidance recently issued by the FDA’s Center for Devices and Radiological Health, which appears to take on a burgeoning set of offerings from the cosmetic industry. The agency clarified the characteristics that would distinguish items that are and are not regulated as devices, explaining that the length and sharpness of the needles in these needle arrays is one indicator of whether such an instrument is indeed a medical device.

Another factor is whether the item in question achieves its primary intended purpose through chemical action within or on the human body, which if so would constitute a medical device. Claims that suggest the device is intended to do nothing more than remove the outermost regions of the epidermis, (the stratum corneum) would not be subject to regulation, but anything suggestive of penetration or delivery of an effect “beyond the stratum corneum into living layers of skin” would likely make that item a medical device.

As of yet, no microneedling devices have gone through regulatory review, and thus anyone who files for a premarket review faces either a class III designation or must file a de novo application. De novo filings are now subject to $93,000 in user fees under the fourth device user fee agreement, although the agency is on the hook for a turn-around of 150 days under this new de novo paradigm. In this first year of the MDUFA IV, only half of de novos have to meet that 150-day turn-around, however.