FDA Commissioner Continues To Roll Out Digital Health Initiatives

FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week.  As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies.  Last week’s speech continued this march, including the following highlights:

Digital Health Innovation Action Plan

Commissioner Gottlieb announced a new policy that streamlines the path for digital health products that contain several functions, some of which are subject to FDA medical device regulation, and some of which are not.  The new guidance, available here, attempts to clarify where FDA will and will not be reviewing certain software functions.  As expected, the focus of the agency’s review will be on the safety and effectiveness of higher-risk medical device functions that diagnose or treat patients.

Pre Cert 1.0 Coming by End of 2018

Last September, FDA announced its “Pre-Cert” pilot program, which focuses on the company’s program of design, testing, validation, operation, and maintenance rather than the features of a specific product to determine whether a company can be “pre-certified.”

Last week, Commissioner Gottlieb announced an update – the release of a Working Model of the program.  It is designed to be a first of several iterations, each informed by input from developers, patients, providers, and the public.  Commissioner Gottlieb said that FDA is committed to launching “Pre Cert 1.0” by the end of 2018, with further refinements in 2019.

Artificial Intelligence (AI) Regulatory Framework and Digital Health Incubator

Commissioner Gottlieb described AI as “one of the most promising digital health tools” and advocated employing the Pre-Cert approach to allow companies to make minor changes to their devices without having to make new submissions each time.  Given this potential, Gottlieb announced that FDA is “actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies.”  He stressed that the regulatory structure must be sufficiently flexible to keep pace with the field.

Consistent with the use of AI and machine learning to inform healthcare diagnoses and decisions, Commissioner Gottlieb announced the creation of an internal data science incubator called the Information Exchange and Data Transformation (INFORMED).  The initial focus of the incubator will be, among other things, “the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer.”  The project will also involve collaborations with Project Data Sphere, the National Cancer Institute, and Harvard University.

Drug Development and Safety Reporting Announcements

Commissioner Gottlieb announced two initiatives relating to drug development and safety.

  • First, in light of the multiple use cases for digital health and prescription drugs, new guidance will be released to address the role of digital health in drug development.  Specifics on timing were not mentioned.
  • Second, a new Premarket Digital Safety Program is underway to enable a unified data standard for meeting electronic reporting requirements under the expedited safety reporting regulations of an Investigational New Drug Application.  The new digital submission process is intended to eventually replace the paper-based system which Commissioner Gottlieb characterized as a “fragmented analog workflow.”

We will continue to follow FDA’s evolution in the regulation of digital health and keep you updated here.

Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found in cannabis that is not considered psychoactive.  If approved, Epidiolex would have orphan drug status, meaning that it is marketed to treat rare diseases or conditions, in this instance rare forms of epilepsy.  FDA is not bound by the advisory committee recommendations, but often follows them.

With Epidiolex’s approval likely looming, one question is what the impact will be on the CBD dietary supplements currently on the market. FDA has made clear that it does not believe that CBD can be legally marketed as a dietary supplement because of GW Pharmaceuticals’ initiation of investigational new drug applications for its products prior to CBD being marketed as a supplement.  Further, FDA has issued numerous warning letters relative to CBD labeled as dietary supplements but that contain little or no actual CBD as well as those that feature express disease treatment claims.  Will the approval of Epidiolex impact those CBD products currently sold as supplements? Continue Reading

Advertising Marijuana Businesses: The Federal Criminal Law You Need to Know

As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to surpass the $5 billion mark in 2019.  As a result, media outlets stand to gain substantial sums in advertising revenue for all the newly-licensed state legal businesses.  But before placing any advertisement, companies need to consider the rarely-used but newly-relevant provision of federal criminal law that addresses advertising.

Although seldom used in federal criminal prosecutions, a provision of the Controlled Substances Act prohibits placing advertisements for marijuana and other Schedule I substances. 21 U.S.C. § 843(c)(1).  Specifically, this provision makes it “unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance.” 21 U.S.C. § 843(c)(1).  So does that mean no one can run advertisements?  No, but it means that advertisements need to be approached with caution.  Continue Reading

Trump and DOJ Pledge to Get Tough on Opioids

On Monday, President Trump delivered an opioid speech in New Hampshire in which he promised to get tough on opioid investigation and enforcement. This follows on the Department of Justice’s (“DOJ”) prior assertion that it will strengthen its efforts against pharmaceutical industry members.

On February 27, 2018, the DOJ announced the creation of a Prescription Interdiction & Litigation (“PIL”) Task Force.

According to the press release, the PIL Task Force is charged with investigating and bolstering existing claims brought by municipalities, carefully monitoring pharmaceutical manufacturer and distributor compliance, and supporting preexisting strategies to combat the opioid epidemic:

“The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors… The PIL Task Force will include senior officials from the offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for U.S. Attorneys, the Civil Division, the Criminal Division, and the Drug Enforcement Administration…The Department will also use all criminal and civil tools at its disposal to hold distributors such as pharmacies, pain management clinics, drug testing facilities, and individual physicians accountable for unlawful actions.”

The Task Force will also create a working group to: (1) improve coordination and data sharing across the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.

On the same day as the PIL Task Force was announced, the DOJ communicated its intention to release a Statement of Interest in the multidistrict opioid litigation hearings headed by various municipalities, occurring in Ohio.

The main thrust of the DOJ’s statement will be that “the federal government – through various federal health programs and law enforcement efforts – has borne substantial costs from the opioid epidemic and seeks reimbursement.”

Keeping You Updated

To keep up to date on this, and other topics related to the Opioid Litigation Epidemic, follow our on-going coverage. For more in-depth updates click here

Judge Overseeing Opioid Lawsuits Takes Unorthodox Approach

Ohio Judge Dan A. Polster, who is handling the multi-district opioid litigation proceedings, is taking a very active hand in the management of the proceedings before him, the New York Times reports.  His methods are unorthodox: calling for minimal discovery, rapid settlement (if possible), and real-world solutions to “clean up this mess.”  Judge Polster’s distinctive personality has already upset some counsel.

Here are some key quotes from Judge Polster’s statements at the first hearing:

  • “People aren’t interested in depositions, and discovery, and trials.  People aren’t interested in figuring out the answer to interesting legal questions like preemption and learned intermediary, or unravelling complicated conspiracy theories.”
  • “And in my humble opinion, everyone shares some of the responsibility, and no one has done enough to abate it.  That includes the manufacturers, the distributors, the pharmacies, the doctors, the federal government and state government, local governments, hospitals, third-party payors, and individuals, hospitals, third-party payors, and individuals.  Just about everyone we’ve got on both sides of the equation in this case.”
  • “But the resolution I’m talking about is really – what I’m interested in doing is not just moving money around, because this is an ongoing crisis.  What we’ve got to do is dramatically reduce the number of the pills that are out there and make sure that the pills that are out there are being used properly.”

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.

Continue Reading

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.