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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“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future required timeframes.  The report comes this week from the U.S. Department of Health and Human Services Office of Inspector General, which used FDA’s inspection data and information about FDA’s advisory and enforcement actions to provide its analysis and recommendations.

Notable findings include:

  • Specified FSMA timeframes.  For the initial cycle, FSMA requires FDA to inspect all high-risk facilities within five years and all non-high risk facilities with seven years.  While FDA is on track to meet these deadlines, FSMA thereafter requires a quicker timeframe – three years for high-risk facilities and five years for non-high risk facilities.  The report found that the shorter timeframe poses a challenge for non-high risk facilities in particular.
  • Inaccurate information.   The report found that more than one quarter of high-risk and non-high-risk facilities that FDA counted toward meeting inspection mandates were attempted inspections but were never actually completed due to the facility being out of business or not in operation.  FDA inspections are generally unannounced.
  • Correcting significant inspection violations.  According to the report, FDA uncovered significant inspection violations in 1-2% of inspected facilities or 1,245 facilities.  FDA most commonly relied on advisory actions such as warning letters, untitled non-public letters, or regulatory meetings to address these issues, as shown in the pie chart to the right.  The report noted that advisory actions do not necessarily ensure that the identified issues are corrected and commented that FDA declined to regularly use the new administrative tools authorized under FSMA, such as administratively detaining unsafe food, mandating recalls of certain foods, and suspending facility registrations and prohibiting the facility from distributing food.
  • Timeliness of follow-up.   The report further noted that FDA may not always timely follow-up with facilities even when a significant inspection issue was identified.  According to the data, about half the time, FDA either did not follow-up within one year (31%) or did not follow up at all (17%).

FDA responded to the report by noting that it concurred with the Inspector General’s recommendations and would implement certain corrective actions to address the identified issues.

Potential Drawback Opportunity for Distilled Spirits

“Drawback” is U.S. Customs program that allows importers to get their duty payments refunded by Customs if they export the same or a similar product.  There are lots of permutations and it’s quite a bit of “paperwork” to qualify, but the upside is significant.

Under the recently enacted Trade Facilitation and Trade Enforcement Act (TFTEA), drawback is being simplified and will be effective Feb 24, 2018.  The importing community is still waiting for certain Customs regulations on this, including whether distilled spirits will be eligible for “substitution” drawback.  Customs has historically denied substitution drawback to distilled spirits.Customs will be issuing a notice of proposed rulemaking in September on substation drawback. It remains to be seen whether distilled spirits are included.  There will be a time for public comments after the notice is issued.If Customs omits distilled spirits, we anticipate the industry will lobby Congress to extend drawback via legislation.

The drawback revised regulations will provide various opportunities for the distilled spirits industry, including submitting comments and government relations efforts.  In the meantime, we are waiting on the Federal Register Notice in September.

WTO and FAO Issue Publication on Trade and Food Standards

The World Trade Organization (WTO) and the UN Food and Agriculture Organization (FAO) recently issued a joint publication, Trade and Food Standards, which discusses the development of international standards and the need for additional regulations and involvement by all countries.

Currently, the global food trade is valued at $1.7 trillion.  The FAO has 188 member countries and guidelines covering almost 200 food products and more than 300 food additives.  The U.S. alone imports food from 150 countries and food products often traverse a complex supply chain to reach the U.S.

The WTO and FAO emphasized that now is the time for additional international standards due to the rise in e-commerce, new production technology, and new international trade agreements. Furthermore, the agencies have organized a partnership to advise developing countries on controlling their supply chains and inspection and certification systems.


Cattle Groups Sue USDA to Compel Country of Origin Labeling (COOL); Launching Newest Standoff in Longstanding COOL Dispute

Two groups representing U.S. cattle producers recently brought suit against the United States Department of Agriculture (USDA) based on the agency’s March 2016 decision to revoke regulations requiring that beef and pork products be labeled with their country of origin.  According to the plaintiffs, Ranchers-Cattlemen Action Legal Fund and Cattle Producers of Washington, USDA’s decision to revoke country of origin labeling (COOL) regulations for beef and poultry products violates the Meat Inspection Act and the Tariff Act of 1930, and goes beyond what was required by a recent decision by the World Trade Organization (WTO) that sparked the repeal.  The action is the latest twist in a longstanding conflict that embroils food regulations, free trade principles, and the First Amendment.

In 2009, USDA issued a final rule that required beef, pork and other commodities slaughtered in another country to bear country of origin labeling at the time of retail sale.  After the WTO ruled that the initial regulations violated WTO standards, USDA issued a revised rule in 2013, which would have required product labels to individually designate where the animal was “born,” “raised,” and “slaughtered,” as those terms were defined under the rule.  The labeling requirements were again challenged – both by Mexico and Canada at the WTO under free trade principles, and by the American Meat Institute and several other meat and livestock organizations on First Amendment grounds, as previously discussed here.  While the D.C. Circuit ultimately upheld the compelled speech requirements under the First Amendment, the WTO again found the regulations to be inconsistent with U.S. obligations under the WTO.

In response to the latest WTO ruling, Congress passed legislation that removed language from the 2002 Farm Bill related to COOL requirements and, in March 2016, USDA issued a final rule that amended COOL regulations to remove muscle cut beef and pork, and ground beef and pork from mandatory COOL requirements.  According to the complaint filed last week, USDA’s final rule went too far and ignored preexisting COOL requirements under the Meat Inspection Act and the Tariff Act of 1930.  Plaintiffs alleged that “[r]ather than act with precision and respond to the WTO’s and Congress’ concerns in a way that also complied with preexisting laws, USDA used a broad brush and deleted beef and pork from its labeling requirements.”

According to the complaint, the WTO’s decision related to labeling requirements for foods derived from imported livestock, and did not affect label requirements for imported beef and pork products (i.e., livestock that had already been slaughtered).  And, while Congress removed cattle, hogs, beef, and pork from products requiring labeling under the 2002 Farm Bill, Congress did not alter longstanding obligations under the Meat Inspection Act and the Tariff Act.  Plaintiffs ask the court to set aside USDA’s regulations to the extent that they fail to require that imported beef and pork comply with COOL requirements under the Meat Inspection Act and Tariff Act of 1930.

FDA: Still in Action on Food Safety Violations

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had seized the food products held by Professional Warehouse and Distribution, Inc., at a food warehouse facility in St. Paul, Minnesota. The related complaint filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the District of Minnesota alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act in reliance on 21 U.S.C. §342(a)(4). The seized products are worth approximately $73,000 and include barley flour, spices, pasta, dried beans, tea and cookies.

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FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements.  The rule initially set a general compliance date of July 26, 2018, although manufacturers with annual food sales of less than $10 million were given an additional year to comply.

The Agency announced the postponement of the effective date by revising online guidance by adding a new subsection on compliance dates entitled, “FDA Intends to Extend Compliance Dates for Nutrition Facts Label Final Rules.”  The Guidance now explains that “industry and consumer groups provided the FDA with feedback regarding the compliance dates” and “[a]fter careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.”

The Agency did not elaborate on the new timeframe for implementation, although it did note that “FDA will provide details of the extension through a Federal Register Notice at a later time.”  As discussed here, the rule requires a revamped Nutrition Facts format that would increase the type size of certain nutrition information, require mandatory declarations for “added sugars,” Vitamin D and potassium, impose a new definition of “dietary fiber,” and revise serving sizes for certain food products.  Last month, the Agency announced that it was extending compliance dates for menu labeling requirements from May 2017 to May 2018.

We will continue to monitor for and post updates regarding the new timeframe for implementation as soon as they become available.