FDA Permits mHealth App That Uses AI to Signal Signs of Stoke

FDA announced last week that it is permitting marketing of an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed by Viz.AI.  It relies on triage software to scan for potential blockages and then notifies a medical specialist via smartphone or tablet.  The anticipated benefit is that quicker identification of blockages will decrease the time to treatment and improve outcomes.

FDA’s press release provides helpful detail for developers regarding how Viz.AI substantiated the efficacy of its app.  “The company submitted a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the Viz.AI Contact application against the performance of two trained neuro-radiologists for the detection of large vessel blockages in the brain. Real-world evidence was used with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected.”

The pathway to market was also unique. As also noted in the press release, “The Viz.AI Contact application was reviewed through the De Novo premarket review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. This action also creates a new regulatory classification, which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

This announcement is welcome news, particularly in light of FDA’s late 2017 Clinical Decision Support guidance, which has been met with frustration by some in industry.  It also follows earlier mhealth innovations specific to stroke treatment, which may provide important tools to hospitals with limited resources or access to neurological specialists.  For more on FDA’s recent digital health initiatives, see our prior posts here.

Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and health information platforms, questions have arisen as to the role that the NAD might play in regulating these advertisements.  For those who are unfamiliar, the NAD is the National Advertising Division of the Better Business Bureau.  It is an industry self-regulatory body that is charged with hearing and rendering decisions in advertising disputes, typically among competitors.  It is commonly used amongst advertisers of consumer-directed products and services.  It is not commonly used amongst prescription drug advertisers and, until recently, many likely assumed that NAD did not have jurisdiction to hear prescription drug advertising challenges.

A relatively recent NAD decision makes clear that that body believes that it has jurisdiction over prescription product advertising, however. Late last year, the NAD evaluated advertising by Synergy Pharmaceuticals for its Trulance product, which is prescribed for chronic idiopathic constipation.  Allergan, maker of a competing product, challenged the advertising on the basis that it included false implied superiority claims, expressly false superiority claims, and undisclosed native advertising in the form of a waiting room pamphlet that allegedly was positioned as independent and impartial patient education material.  Continue Reading

FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act.  In addition to the 11 joint warning letters issued to named marketers and distributors, the FTC issued four additional warning letters to unidentified marketers of similar products.  It is not clear why these four marketers were not identified by name or targeted by FDA, although it is possible that they used less egregious claims than those targeted in the 11 joint warning letters.

As to issues under the FDCA, the warning letters allege that the identified products are unapproved new drugs because they are intended to diagnose, cure, mitigate, treat, or prevent disease.  The warning letters identify representative claims that render the products “drugs” under the FDCA, including:

  • “For temporary relief of cravings, irritability, and inability to concentrate related to the use and over-use of. . .  alcohol and narcotics”;
  • “Support withdrawal relief, effective detox, and lasting recovery from addiction”; and
  • “Opiate withdrawal aid supplement.”

Because the products are not generally recognized as safe and effective for these marketed “drug” uses, the products constitute unapproved new drugs that violate the FDCA, according to the warning letters.  The warning letters further provide that the products are marketed for treatments that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner, and thus would be prescription drugs even if they were recognized as a safe and effective treatment for opiate withdrawal.

Two warning letters targeted products labeled as “homeopathic” under FDA enforcement policies set forth in FDA’s Compliance Policy Guide (CPG), “Conditions Under Which Homeopathic Drugs May be Marketed.”  While that policy suggests that FDA will exercise enforcement discretion as to certain drug products labeled as “homeopathic” and marketed without FDA approval, the letters state that the CPG acknowledges that special circumstances may apply that supersede that policy.  According to the warning letters, the nationwide public health emergency relating to opioid addiction is one such circumstance and thus the enforcement policy does not apply to drugs marketed for opiate addiction.  In December 2017, FDA released a draft guidance that proposed a new risk-based enforcement approach to homeopathic drug products marketed without FDA approval that would prioritize regulation and enforcement for products that pose the greatest risk to patients.

As to the FTC Act violations, the warning letters note that health-related claims must be supported by competent and reliable scientific evidence at the time the claims are made.  The warning letters point to previous FTC enforcement actions challenging unsupported claims for the treatment of opiate addiction and withdrawal symptoms as evidence that such claims are likely unsubstantiated under the FTC Act.

The warning letters request unique responses to both FTC and FDA within 15 working days and direct the marketers and distributors to explain the steps they are taking to address both FDA and FTC-related concerns.

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities, as one way that the agency seeks to further its public health mission and foster innovation that benefits consumers and patients.  Consistent with this focus, the agency also announced a public workshop on January 30-31, 2018, to discuss the status of its Software Pre-Cert Program, which we wrote about here.

These announcements follow a consistent drumbeat of digital health focus from FDA during 2017, including release of two draft and one final guidance documents that are intended to implement the objectives of the 21st Century Cures Act.  These include the following:

  • The Clinical and Patient Decision Support Software (CDS) Draft Guidance. As explained by FDA, this guidance “is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation… However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.” The comment period is open until Tuesday, February 6, 2018.
  • The Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Draft Guidance.  This draft guidance updates the agency’s thinking relative to exercise of jurisdiction or enforcement discretion over low risk mobile and digital health products, as previously addressed in FDA’s Mobile Medical Application and General Wellness guidance. The deadline for public comments is Tuesday, February 6, 2018.
  • The Software As A Medical Device (SaMD): Clinical Evaluation Final Guidance. This finalizes draft guidance issued in 2016 and attempts to further global regulatory harmonization efforts by establishing common principles for regulators to use in evaluating the safety, effectiveness and performance of SaMD.

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AG Sessions Ends Obama-Era Policies Governing Federal Marijuana Enforcement; Sudden Wave of Enforcement Unlikely

Timed almost to the day that California legalized recreational marijuana, Attorney General Jeff Sessions announced on Thursday, January 4, that the Department of Justice has rescinded the Obama-era guidance (the Cole Memo) issued to federal prosecutors relative to marijuana enforcement. The announcement characterizes the move as an effort to restore prosecutorial discretion, noting that the U.S. Attorneys’ Manual requires prosecutors to weigh all relevant considerations in determining which cases to bring, including the seriousness of the crime, the deterrent effect of the prosecution, and the cumulative impact of particular crimes on the community. Notably, the announcement also appears to characterize marijuana as a contributor to “the growing drug crisis.”

This development is not a surprise. Attorney General Sessions has made a number of statements that reflect a view that marijuana is properly classified as a Schedule I narcotic under the Controlled Substances Act, putting it in the same category as heroin. Nevertheless, given that eight states (Alaska, Washington, Oregon, California, Colorado, Nevada, Maine, and Massachusetts) and the District of Columbia have legalized recreational marijuana and 29 states allow medical marijuana, it opens questions as to federal enforcement priorities and risks for companies operating or considering doing business with the cannabis industry.

While recreational marijuana may seem like the obvious target for future enforcement, Sessions has not limited his stated concerns about marijuana to recreational use. In a May 2017 letter to House and Senate leaders, Sessions specifically renewed the DOJ’s objection to any limitation on its ability to enforce the Controlled Substances Act. Consistent with the language used in the January 4 announcement, Sessions characterizes state-regulated medical marijuana as a contributing factor in the “historic drug epidemic and potentially long term uptick in violent crime.”

It is also not clear from his public statements, such as this one from his confirmation hearing, whether Attorney General Sessions has specific opinions as to CBD, a non-psychoactive derivative that can be produced either from cannabis or industrial hemp. CBD has been legalized in many states but its legal status at the federal level depends on whether the product is derived from cannabis (Schedule I narcotic) or industrial hemp, a legal substance.  However, as we have written about here, it is likely that the Food and Drug Administration remains the agency most interested in CBD product classification and claims.

Wave of Enforcement Unlikely

It also seems likely that, even though the Cole Memo no longer stands as official agency guidance, its principles will continue to guide prosecutors’ decision-making, rendering a sudden wave of law enforcement activity unlikely. Whether to take action will be up to individual U.S. Attorney’s Offices, and, in exercising their prosecutorial discretion, those Offices will look primarily to the seriousness of the crime.  In assessing seriousness, in turn, prosecutors will most likely look back to the newly-rescinded Cole Memo, which sets forth the top priorities for law enforcement.  So even though the Cole Memo now lacks any formal effect, it likely will remain the best guide for U.S. Attorney’s Offices in terms of prioritizing marijuana cases.  What that means is that those in violation of state law, or engaged in distribution to minors, or engaged in other criminal activity, will be the most likely to attract law enforcement attention, just as they were prior to the Attorney General’s announcement.  State compliant medical marijuana businesses, and the ancillary business who provide products or services to them, will remain the least likely.

Notwithstanding that the risk to ancillary businesses providing services to state compliant marijuana businesses remains low, financial institutions are likely to have heightened concerns, and those previously on the fence about whether bank marijuana-related businesses will probably take a wait-and-see approach for a while. However, those that continue to engage in the due diligence steps set forth in 2014 by the Financial Crimes Enforcement Network (FinCEN) are unlikely to find themselves the target of law enforcement activity. After all, there is increasing recognition that the scrutiny and record-keeping that financial institutions bring to marijuana-related businesses is beneficial to law enforcement.  Without them, the industry is forced to rely on large movements of cash, which poses a security risk to the businesses, raises the risk of money laundering and other illicit activity, and makes that activity more difficult to detect and prevent.

Elected officials from several states, particularly those with legalized recreational marijuana, have already expressed opposition to the DOJ’s announcement.   We will continue to follow this issue closely and provide updates here.

Litigation Is Not The Solution To The Opioid Epidemic

The causes of the opioid epidemic are myriad and unique, and undermine the legal claims faced by manufacturers. Opioids are not tobacco, and pharmaceutical companies — who produce and distribute medicine that for many provide vital relief from chronic, agonizing pain — are not cigarette companies. Read our Law360 article discussing how the opioid crisis is a public health problem and it is irresponsible to fit the pharmaceutical industry into the mold of Big Tobacco.  Our bottom line is that litigation is not a proper solution. 


Preparing for the Opioid Litigation Epidemic

One of the newer symptoms of this so-called “Opioid Epidemic,” is a rash of litigation targeting pharmaceutical manufacturers and distributors. Currently, there are actions underway in Texas, West Virginia, Alabama, Ohio, Mississippi, South Carolina, Kentucky, Washington, Illinois, California, New York and more new suits are being filed.

In each of these claims, specific acts and specific harms attributable to actual elements of causation must be determined. This is difficult to do when the quality of the ostensible harm, the full diasporic spectrum of the “epidemic,” is so variable. Furthermore, there are a plethora of intervening actors between pharmaceutical companies and the community, any of whose independent behavior could supersede and break the causal chain required to hold opioid manufacturers liable. For example, studies conducted by the University of Arkansas looking at the transition from acute to periodic opioid use seem to suggest that the most effective way of reducing the risk of abuse might be through doctors limiting initial prescriptions, leaving shorter periods of time between refills, and so preventing unnecessary accumulation of medication. Continue reading our client advisory here.

H.R. 3985 Calls For Public-Private Working Group to Study Medical Device Security

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month.  Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would require establishment of “a working group of public and private entities to develop recommendations for voluntary frameworks and guidelines to increase the security and resilience of networked medical devices sold in the United States that store, receive, access, or transmit information to an external recipient or system for which unauthorized access, modification, misuse, or denial of use may result in patient harm.”

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FDA and EPA Issue Joint Guidance On Jurisdiction Over Mosquito-Related Products

Last week, FDA and the EPA issued guidance for industry regarding each agency’s respective jurisdiction over mosquito-related products.  With the emergence of the Zika virus and the urgency in countering the spread of mosquito-borne diseases taking on new prominence, the agencies acknowledged that “novel mosquito control technologies have gained greater attention as an element of [vector control]; however, there has been some confusion with respect to FDA’s and EPA’s respective jurisdiction over mosquito-related products.”   Key points of the guidance include the following:

  • Mosquitoes fall within the statutory definitions of “drug” per the FD&C Act and “pest” per the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
  •   In 1975, Congress amended FIFRA’s definition of “pesticide” in FIFRA to exclude any article that is a “new animal drug,” within the FD&C Act.  Since then, EPA has required registration, as pesticides, articles that control the mosquito population by killing them or interfering with their reproduction.
  • Given this history, with the new guidance, FDA is clarifying that the phrase “articles (other than food) intended to affect the structure or any function of the body of man or other animals” in the FD&C’s drug definition does not include articles intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes.
  • Examples of New Animal Drugs regulated by FDA include products intended to reduce the virus/pathogen load within a mosquito or products intended to prevent mosquito-borne disease in humans or animals.
  • Examples of Pesticide Products regulated by EPA include products intended to reduce the population of mosquitoes (for example, by killing them or interfering with their reproduction).

This guidance potentially applies to a wide variety of products, including those produced through biotechnology.  One point that is not addressed in the guidance but that is of interest to industry is that the Federal Trade Commission also has jurisdiction over the advertising of insect repellent products.  Last year the agency issued warning letters to companies making Zika-related claims.

As mosquito-borne disease spreads, mosquito-related products will proliferate.  Companies will need to determine at the outset which agency or agencies have jurisdiction to ensure compliance.

Digital Health Update: Tech and Health Care Giants Selected for FDA’s Pre-Cert Program

In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry.  Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the agency describes as “intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.”

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