The current United States marketplace for the regulation of pharmacy benefits is a patchwork of inconsistent (and in some cases non-existent) state laws, state and federal agency regulations, agency manuals and federal laws. Uniform state laws would pave the way for more certainty and less confusion. A Model Act with uniform state laws would be welcomed, so long as the Model Act properly took into account the interests of all stakeholders, including patients. Unfortunately, the currently proposed Model Act does not do so.
On October 26, 2020, the National Association of Insurance Commissioners (NAIC) approved a Pharmacy Benefit Manager (“PBM” ) Licensure and Regulation Model Act (“The Model Act”) which essentially mirrors that previously developed by the National Conference of Insurance Legislators (NCOIL). The Model Act puts forth a template for states’ regulation of unfair PBM practices. Over the past few years, pharmacies have filed dozens of lawsuits and countless “confidential” arbitrations against PBMs for various unfair business practices such as network terminations, refusals to permit pharmacies into restricted PBM networks, lack of transparency regarding both rebates and spread pricing, as well as direct and indirect remuneration (“DIR fees”) and predatory reimbursement rates generally. A number of these have been consumer class action lawsuits. For their part, the PBM lobby group, Pharmaceutical Care Management Association (“PCMA”) has filed dozens of lawsuits attacking newly enacted state laws.
Stronger state regulation may obviate the need for some of these lawsuits. The key provisions of the Model include:
- Requiring that PBMs operating in a state to obtain licensure with each state’s governing authority
- Providing for state authority for the audit of PBMs for compliance with the Model’s provisions
- Placing a “fiduciary duty” on PBMs to protect the financial interests of their Plan Sponsor clients
- Banning Gag Clauses in PBM contracts that unceremoniously prevent pharmacies from telling patients the truth about drug pricing
The proposed Model is primarily directed at PBM licensure and omits specific guidance other than passingly mentioning many of the abusive PBM business practice provisions that individual states have enacted. The Model does little to address many of the important issues for pharmacies such as PBM network adequacy, data reporting requirements under state price-gouging laws, reimbursement claw back prohibitions, spread pricing, rebate transparency, DIR fees, network termination, network access, Maximum Allowable Cost (“MAC”) pricing appeals, prohibitions and limitations on the corporate practice of medicine, procedures limiting PBM audits of pharmacies, , medical loss ratio (MLR) compliance, reimbursement lists or payment methodology used by PBMs, and transparency provisions. Instead, the Model leaves it up to the states to customize their regulations.
Pharmacy groups are seeking to have these important provisions be added to the provisions that a State Commissioner would be required to adopt, rather than having them as permissive or optional provisions. Perhaps the most important provision for pharmacies and states in the Model is the narrowing of the language to minimize potential Employee Retirement Income Security Act (ERISA) challenges. Comments have been requested from interested parties on this draft which is expected to be finalized by the end of the year.
How Frier Levitt Can Help
Frier Levitt, LLC offers a full range of Government Affairs/Advocacy services to assist pharmacies and other stakeholders work with state and federal legislators and regulators to adopt favorable PBM legislation, prepare position papers, testimony and comments. Frier Levitt, LLC has experience handling thousands of PBM-related matters for pharmacies, health plans, Plan Sponsors, wholesalers, drug manufacturers and other healthcare providers. PBM audits can make or break an independent pharmacy’s business. Contact Frier Levitt today to speak with our PBM attorneys, many of whom are also pharmacists.
In May 2019, the United States Patent and Trademark Office (USPTO) issued an Examination Guide (Guide) outlining a pathway for trademark registration for certain cannabis and cannabis-related goods and services (including CBD). This reversed its previous policy prohibiting any cannabis-related trademark registrations. As a result of the USPTO’s Guide and the anticipated competitive business environment of this field, we expect to see a significant influx of cannabis-related trademark applications. Brand protection is important in all industries and cannabis-related companies spending time, effort and money branding their products understand the benefits of a federal trademark (notable examples include Marley Natural™ and Leafs by Snoop™) (Snoop Dogg).
Benefits of brand protection include:
• Ability to use the registered trademark symbol (®) to put others on notice that your brand exists and is protected
• Incontestability after 5 years of continuous use
• A basis for foreign registrations
• Use of U.S. Customs and Border Protection to block imports that infringe on the mark
• Prevention of loss of goodwill (and sales) by inferior infringing products
• Intellectual Property value added in licensing agreements and merger and acquisitions
The key provisions of the USPTO Guide are:
• To be eligible for Federal Trademark protection the goods and services must be hemp-derived and must have less than 0.3% tetrahydrocannabinol (THC). The trademark application must
explicitly state this is the case.
• The underlying product or service must be legal under federal law, including the Agriculture Improvement Act of 2018 (2018 Farm Bill) (which made hemp-derived cannabis products with THC
less than 0.3% federally legal), and under state law. The USPRO reiterated its position that trademarks relating to illegal goods and services are not eligible for trademarks, even if they are legal
under state (but not federal) laws.
• USPTO will determine the legality of the product or services (i.e. trademarkability) based on an analysis of: The Controlled Substances Act (CSA), The Federal Food Drug and Cosmetic Act
(FDCA), and The Farm Bill.
• USPTO will take into account Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulations when determining “lawful use” issues. For example, FDA restrictions exist for hemp-derived foods, beverages, dietary supplements or pet treats which will affect trademarkability.
• The application filing date must be after December 20, 2018. For applications filed prior to that date, Applicants may either amend the application to change the date or file a new application.
How Frier Levitt Can Help
A cursory search using the search terms cannabis or hemp revealed over 4,000 trademarks and applications. Clearly, the USPTO has opened the door for cannabis-related trademarks (including for CBD products). The trademarkabilty of such products and services is a nuanced and evolving issue. For assistance in navigating the trademark examination process for cannabis marks, contact Frier Levitt, LLC.
Market exclusivity rights afforded by intellectual property such as patents, copyrights and trademarks can provide a crucial advantage to cannabis businesses. In addition to providing a valuable market advantage, intellectual property is extremely advantageous to cannabis companies seeking funding from sources such as venture capital that often look for companies with patent applications on file. Although cannabis-related patenting is still in its infancy, over 2,000 active cannabis-centric patents/applications have already been issued or published, and as evidenced by the last few months in 2019, the number is skyrocketing. Most of these patents are for technologies such as cultivation, processing and extraction techniques, cannabis-derived products, and medical treatments.
The U. S. Patent & Trademark Office’s (USPTO) willingness to grant cannabis patents, copyrights and trademarks may or may not translate to a willingness on the part of the USPTO Patent Trial and Appeal Board (PTAB) and Federal Courts to enforce them. Since cannabis remains a Schedule I drug under the Controlled Substances Act (CSA), some have opined that the so-called “illegality doctrine” may preclude cannabis-related patent infringement cases as well as other cannabis-related commercial disputes. Pursuant to the illegality doctrine, judges could potentially decline to entertain a lawsuit, hold that the USPTO exceeded its authority, or decide that there is no entitlement to damages with regard to intellectual property related to illegal activity.
Although possible, we believe the “illegality doctrine” should not be applied to cannabis-related patents for several reasons. Most notably, cannabis-related patent enforcement cannot be hindered by the government or federal courts when the federal government itself created the patent. That is, these patents cannot be considered the result of illegal activity when the patent rights are conveyed by the federal government under patent statutes. Nor do patents convey any right to engage in activity illegal under the CSA. Additionally, it is worth noting that patents related to cannabidiol (CBD) which contains less than 0.3% THC on a dry weight basis would clearly relate to a legal product pursuant to the Agricultural Improvement Act of 2018 (P.L. 115-334) “Farm Bill” which legalized such products on the federal level.
Thus far, both the PTAB and the Federal Courts have NOT treated cannabis patents differently than other patents. On January 3, 2019, the USPTO PTAB issued a Final Written Decision in the case Insys Development v GW Pharma Ltd (IPR 2017-00503) upholding 11 claims relating to U.S. Patent No. 9,066,920 which addresses the use of phyto-cannabinoids in the treatment of epilepsy. Notably, the PTAB did not raise the issue of the legality of a cannabis patent and treated the cannabis patent as it would any other patent, focusing on typical issues that relate to all patent challenges such as patentability, scope, claim construction, infringement, ownership and enforceability.
Despite the Growth of the Cannabis Industry, Uncertainty and Limited Legal Guidance Exist
The USPTO’s experience with cannabis patents is evolving as is the universe of prior art used to challenge the validity of patent claims based on novelty or obviousness. Regardless of the IP strategy chosen, IP protection should be a primary consideration for cannabis companies.
How Frier Levitt Can Help
Frier Levitt offers a full range of Intellectual Property services including patent, trademark and copyright procurement, trade secret and confidentiality agreements, infringement and Freedom-to-Operate Opinions and due diligence. Our pharmacist attorneys provide a nuance understanding of the science, chemistry as well as related Life Sciences and FDA issues. Please contact our Intellectual Property attorneys if you require advice or have questions.
As part of an ambitious new state hemp program, the Florida Department of Agriculture and Consumer Services (the “Department”) announced that new food safety and animal feed rules went into effect as of January 1, 2020. Agriculture Commissioner Nikki Fried stated that the new regulations are crucial in “getting the state hemp program up and running to provide a new alternative crop for farmers, allow Floridians to access safe, quality CBD products, and help [the] state reach its potential as the nation’s gold standard for hemp.” These new regulations are intended to support the continued sale of hemp and its derivatives products, including CBD, while ensuring that consumers are protected.
Under the new regulations, any hemp extract or product containing hemp extract intended for human ingestion and for animal ingestion will be regulated by the Department. Any business that manufactures, processes, packages, holds, prepares or sells food made from or containing hemp extract is required to obtain a Hemp Food Establishment Permit to operate in Florida. Food consisting of hemp or hemp extract (including CBD) must be obtained from an “Approved Source” that meets certain local, state or federal food safety standards. Such foods are also subject to specific labeling requirements. Food containing hemp extract must have a THC concentration of less than 0.3% on a dry weight basis and the food must contain less than set limits of certain contaminants used in the hemp cultivation process. As part of the on-going efforts to minimize risk of foodborne illnesses, the Department will conduct routine inspections on such businesses.
Significantly, the new regulations allowing sale of ingestible hemp and hemp-derivative products runs counter to the United States Food and Drug Administration’s (FDA) current stance on these products. Despite the 2018 Farm Bill legalizing hemp with a THC concentration of less than 0.3% on a dry weight basis, CBD products are still subject to FDA’s laws and regulations, including those that apply to foods, beverages and dietary supplements. In this vein, FDA stated that “[i]t is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
In the wake of FDA’s regulations on CBD products, a spate of class action lawsuits have been filed by consumers against CBD manufacturers mimicking FDA’s concern over illegal sale of CBD products including ingestibles for human and animal consumption. Meanwhile, U.S. District Judge Ursula for the Southern District Court of Florida in a class action lawsuit ruled on January 3, 2020 that a CBD manufacturer should not face certain liability claims until FDA finishes work reviewing CBD policy. In her opinion, Judge Ursula stated that the FDA’s current rules “provide little guidance with respect to whether CBD ingestibles, in all their variations are food supplements, nutrients or additives and what labeling standards are applicable.”
How Frier Levitt Can Help
Certainly, Florida’s newly enacted regulations have opened a door while further complicating the legality of ingestible hemp and hemp-derived products, which in turn impact industry Stakeholders including the extractors, manufacturers, wholesalers, and retailers. While many states will choose to wait until FDA issues its much-anticipated regulatory framework for hemp-derivative and CBD products, we envision that more states may take the necessary steps to enact regulations similar to Florida’s. Given the clash between federal and state laws, it is crucial for Stakeholders in the hemp industry to understand the current laws and regulations. If you need assistance navigating the regulatory environment for hemp, CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.
The U.S. Department of Agriculture (“USDA”) has announced a notice of comment period extension on the Hemp Production Program Interim Final Rule allowing hemp stakeholders to submit comments until January 29, 2020. By way of brief background, the Agriculture Improvement Act of 2018 (“2018 Farm Bill”) required USDA to establish the Program, which attempts to clarify the regulatory frame for States and Indian Tribes for the domestic production of hemp.
The Rule outlines provisions for the States and Indian Tribes to submit hemp plans for USDA approval. It also establishes THC testing protocols, interstate transportation, licensing protocols, and eligibility rules for federal programs (e.g., loan and crop insurance programs). More specifically, by and through the Rule, USDA is imposing strict sampling and testing requirements to ensure that the hemp does not contain THC exceeding 0.3%. However, farmers would not be considered in violation of the Rule unless the hemp crops contain THC exceeding 0.5%. Notwithstanding this, farmers are required to dispose any hemp crops with 0.3% – 0.5% THC. Furthermore, the Rule allows hemp to be transported across state lines even in the instances where the state does not authorize hemp production. Of note, states may enact stricter regulations impacting the production, transportation, and sale of the hemp and its derivatives.
As indicated above, the Rule provides much needed guidance to producers and farmers. However, it does not have any bearing on the FDA’s regulation on the hemp and its derivatives in food, beverage or dietary supplements. In other words, stakeholders in the hemp industry must comply with not only FDA and USDA regulations but also state laws that are often not in line with the federal regulations. Moreover, the Rule does not address several key issues including, but not limited to, seed certification, total THC testing instead of the delta-9 tetrahydrocannabinol testing, and the potential issues arising from testing out of only Drug Enforcement Administration registered labs.
With the exponential growth in the hemp industry and the growing regulatory concerns, Stakeholders should review the Rule in detail and submit comments to USDA. Frier Levitt assists state and national associations around the country in drafting proposed legislation. Our “request for comment” work has played a prominent role on important national issues. If you want to learn more about the Interim Final Rule or would like to submit comments before January 29, 2020, contact Frier Levitt today. Time is of the essence.
By: Dae Y. Lee, Pharm.D., Esq., CPBS
Six class action lawsuits have been filed against cannabidiol (CBD) manufacturers immediately following the November 25, 2019 warning letters issued by the United States Food & Drug Administration (FDA). These warning letters were sent to 15 companies for selling products containing CBD. The FDA maintains that food and dietary supplements are not allowed, under the Food, Drug, and Cosmetic Act (FD&C Act), to contain any level of CBD. The FD&C Act makes it clear that any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy. The FDA has sent numerous warning letters to companies that sell CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases. However, the FDA has not launched a judicial action against a CBD manufacturer.
The class action lawsuits are identical to each other and each complaint mimics the FDA’s concerns over illegal sale of the CBD products. Four cases, DaSilva v. Infinite Product Co. LLC, Davis v. Green Roads of Florida, LLC, McCarthy v. Charlotte’s Web Holdings, Inc., and Colette v. CV Sciences, Inc., alleging that the manufacturers’ CBD products were mislabeled as dietary supplements. Two cases, McCarthy v. Elixinol, LLC, and Fausett v. KOI CBD, LLC, note that the defendants sold CBD products as dietary supplements as well as animal foods. KOI CBD, LLC is among the 15 companies that received the most recent FDA warning letters. Prior to these lawsuits, there have been several lawsuits that have been filed against CBD manufacturers including a shareholder class action lawsuit filed against Curaleaf Inc. when the company’s stock fell abruptly after it received a warning letter from the FDA.
The recent lawsuits suggest a new wave of litigation in the CBD industry given that the FD&C Act does not provide for a private right of action under which members of the public can commence a civil action to enforce the FD&C Act. The putative classes assert, instead of arguing that the use of CBD in products violates the FD&C Act, that the CBD products are mislabeled and falsely advertised under state consumer protection laws. More specifically, the plaintiffs allege that the defendants manufactured and sold CBD products in violation of California and Arizona state laws including, but not limited to, California’s Unfair Competition Law, False Advertising Law, and Consumer Legal Remedies Act, and Arizona’s Consumer Fraud Act.
Many future lawsuits are expected to focus on allegations of mislabeling, accusing the companies of falsely representing the CBD content of their products. The lawsuits will likely involve not only the manufacturers but also other stakeholders in the supply chain including extraction and remediation companies. CBD stakeholders should prepare for the possibility of litigation and actively seek to mitigate the risks of unwanted attention by FDA or civil lawsuits. It is likely that more issues will surface given the ever-evolving regulations in the CBD industry. Frier Levitt helps CBD companies and manufacturers navigate complex issues, including many services based on flat fees. Contact Frier Levitt today to speak to an attorney.
By: Adam S. Bloom, Esq. and John E. Morrone, Esq.
On November 25, 2019, the Food and Drug Administration (FDA) issued warning letters to 15 companies selling cannabidiol (CBD) and published a revised Consumer Update broadly detailing its safety concerns regarding CBD products. In addition, the FDA said it intends to provide an update “in the coming weeks” on its progress towards developing a regulatory approach to CBD products.
Each of the companies that received warning letters sold their products online in “interstate commerce.” The products sold include a wide range of CBD products including oils, creams, tinctures, capsules, dietary supplements, human foods (such as gummies and chocolates) and animal foods. As has been the case in each of their previous CBD-related warning letters, the FDA focused its attention on companies that market CBD products with claims that the products cure, mitigate, treat or prevent diseases such as cancer, diabetes, opioid addiction, schizophrenia, multiple sclerosis, autism, Crohn’s disease, depression, and arthritis.
Although each of the targeted companies made illegal disease claims, the FDA made it a point to emphasize that the CBD foods (including animal foods) and dietary supplement products were in further violation of the Food, Drug and Cosmetic Act (FDCA). The FDA stated it is illegal to introduce into interstate commerce human or animal food containing CBD because CBD is an unapproved food additive – it is not Generally Recognized as Safe (GRAS) among qualified experts, and no food additive regulation authorizes its use in foods. The FDA also noted that CBD cannot be marketed as a dietary supplement because it does not meet the definition of a dietary supplement under the FDCA.
Additionally, the FDA emphasized its concern with the marketing of CBD products to children. For example, they called out a CBD product named “Asteroid Gummies” which was advertised with the claim that consumers can give the product “as a treat to your kid[.]”
Significantly, in the revised Consumer Update, the FDA conveyed its belief that there are many unanswered questions and data gaps about CBD safety and that the limited data it has seen regarding CBD point to “real risks.” The FDA’s safety concerns regarding CBD include potential liver injury, the effect of interactions with other drugs, drowsiness, diarrhea, changes in mood, effects on male reproductive health, impact on vulnerable populations such as children and pregnant or breast-feeding women, and the cumulative effects of CBD use.
In an FDA press release issued in conjunction with the warning letters and the revised Consumer Update, the FDA Principal Deputy Commissioner Amy Abernathy, M.D., Ph.D., emphasized that they are monitoring the CBD marketplace and will take action against companies that “violate the law in ways that raise a variety of health concerns.” She added that FDA believes there are “knowledge gaps” about the science, safety, and quality of many CBD products and that the FDA is concerned that people wrongly believe many CBD products have been evaluated by the FDA and determined to be safe or that trying CBD “can’t hurt.”
By issuing 15 new warning letters and articulating its concerns regarding CBD safety, FDA has reiterated its commitment to overseeing the CBD industry and demonstrated the risks of marketing CBD products without a thorough understanding of the unsettled and complex CBD regulatory environment. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.
By: Adam S. Bloom, Esq. and John E. Morrone, Esq.
On October 29th, 2019, the U.S. Department of Agriculture (USDA) released an interim final rule establishing a national regulatory framework for domestic hemp cultivation. The interim rule is intended to facilitate and expand production and sales of domestic hemp and marks a major milestone in the establishment of a nationwide hemp industry.
The interim rule creates baseline requirements for hemp production but allows states and Native American tribes to establish more restrictive plans, subject to USDA approval. If a state does not implement its own plan, the USDA plan will apply. Also, notably, the rule prohibits states and tribes from banning the interstate transport of hemp that has been legally grown under the program.
The interim rule includes requirements regarding collecting and maintaining relevant information on the land used for hemp production; procedures for sampling and testing to ensure the cannabis grown and harvested does not exceed the acceptable hemp THC level (no greater than 0.3% THC concentration level on a dry weight basis); procedures for ensuring effective disposal of plants exceeding the acceptable hemp level; compliance procedures to ensure hemp is being produced in accordance with applicable requirements including conducting annual inspections and procedures for handling violations; and procedures for reporting specific requirements to the USDA.
The USDA also issued guidelines for sampling and testing procedures for hemp. Samples, which have to be collected approximately two weeks prior to a crop’s anticipated harvest date, must be tested at Drug Enforcement Administration (DEA)-registered laboratories.
There is a 60-day comment period during which interested persons may submit comments on the interim rule. After reviewing and evaluating the comments, USDA will draft and publish a final rule within two years.
Federal and state laws regarding hemp, CBD, and other cannabis-derived products are rapidly evolving and there are many potential pitfalls for operating in these markets without a thorough understanding complex regulatory environment for such products. If you need assistance navigating the regulatory environment for hemp, CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.
On October 10, 2019, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to Florida-based Rooted Apothecary, LLC, for selling cannabidiol (CBD) products with unsubstantiated claims that the products treat or cure a variety of serious diseases and health conditions, including claims that the products treat certain conditions in infants. The warning letter reflects the FDA’s continuing concern over CBD products marketed for therapeutic or medical uses, and emphasizes the FDA’s concern over CBD products marketed for use by infants and/or children.
The FDA found various products marketed by Rooted Apothecary to be unapproved new drugs because the company’s website and its social media website included claims that the products are intended to diagnose, cure, mitigate, treat or prevent diseases including Parkinson’s, Alzheimer’s, depression, anxiety, PTSD, attention deficit/hyperactivity disorder (ADHD), cancer, and diabetes.
In addition, the FDA found that Rooted Apothecary unlawfully marketed certain CBD products as dietary supplements. As noted in previous warning letters, the FDA considers products containing CBD to be excluded from the definition of dietary supplements because CBD is the active ingredient in the FDA-approved drug Epidiolex, and CBD was not marketed as a dietary supplement or conventional food prior to the authorization of the clinical investigations of Epidiolex.
The FDA was particularly concerned that Rooted Apothecary markets certain CBD products to infants and children. For example, the company claimed that the “Teeth/TMJ – Essential Oil + CBD Infusion” product will “help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.” The “Ears – Essential Oil + CBD Infusion” product included the claim, “We formulated this for the entire family including our precious little ones.” Further, the company’s website included webpages with statements such as “CBD oil . . . seems like an attractive and safe option for children” and “children can use high amounts of CBD safely and without any risk.”
Regarding the warning letter, Acting FDA Commissioner Ned Sharpless, M.D., said, “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.” Dr. Sharpless added, “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements.”
The FTC warned Rooted Apothecary that it is concerned that the company lacks the requisite “competent and reliable scientific evidence” to substantiate claims that its products can prevent, treat or cure human disease.
This latest warning letter from the FDA and FTC again highlights the potential pitfalls of marketing CBD products without a thorough understanding of the unsettled and complex regulatory environment for such products. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.