Category: Drug & Cosmetic Law

FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.

In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom. For example, as our readers may know, FDA has warned about both the high levels of heavy metals found in kratom products and the contamination of certain kratom products with salmonella. Indeed, FDA issued its first ever mandatory recall order for the salmonella-containing kratom products.

The June 25 warning letters allege that the companies used their websites and social media to illegally market kratom products and made unproven claims about the ability of the products to cure, treat, or prevent disease. Examples of the claims include:

  • “Kratom acts as a μ-opioid receptor-like morphine.”
  • “In fact many people use kratom to overcome opiate addiction.”
  • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
  • “Usage: It is for the management of chronic pain, as well as recreationally.”

FDA reiterates that “[t]hese products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.” FDA has requested responses from both companies within 15 working days.

© 2019 Keller and Heckman LLP
For more on FDA regulation see the National Law Review Biotech, Food and Drug page.

Historic Vote in Congress Aims to Protect State Cannabis Programs

By a vote of 267 to 165, the United States House of Representatives (the “House”) passed a bipartisan amendment protecting state cannabis programs and its users from federal prosecution.

Named after its co-founder, Representative Earl Blumenauer (D-OR), the Blumenauer amendment explicitly prohibits the United States Department of Justice (the “USDOJ”) from utilizing federal tax monies to enforce the federal prohibition of marijuana in states that have legalized cannabis.

The Blumenauer amendment constitutes a significant diversion from prior Congressional action on state cannabis programs.  Since 2014, Congress has enacted similar appropriations riders which only protected state medical cannabis programs.  The Blumenauer amendment, however, protects all state cannabis programs.  Thus, for the first time, the House has passed an amendment protecting the recreational consumption of cannabis.

Regarding funding, the USDOJ is simply no different than any other federal agency.  Without proper funding, an agency cannot enforce or otherwise impose its mandate on behalf of the federal government.  Thus, for all intents and purposes, the Blumenauer amendment validates state cannabis programs and protects those operating under them.

While the Blumenauer amendment still requires passage through the Senate and President Trump’s signature, the House’s actions are a historic step forward for the federal legalization of cannabis in the United States.

© Steptoe & Johnson PLLC. All Rights Reserved.
This post was written by Ryan D. Ewing and Joshua L. Jarrell of Steptoe & Johnson PLLC.
For more on marijuana laws see the National Law Review page on Biotech, Food & Drugs.

USPTO Issues Examination Guide on Trademark Applications for Cannabis and Cannabis-Related Goods and Services

On May 2, 2019, the United States Patent and Trademark Office (“USPTO”) issued Examination Guide 1-19 (“Examination Guide”), which outlines the path to registration for trademark applications covering hemp-based goods and services.  The issuance of the Examination Guide serves as a departure from the USPTO’s longstanding bar to the registration of cannabis-related marks, and signals the potential for further relaxation of the USPTO’s prohibition on federal registration of trademarks and service marks for cannabis and cannabis-related goods and services as state legalization of cannabis continues to crop up across the country.

To obtain federal registration for a mark, a mark’s use in commerce must be lawful under federal law.  See generally Trademark Manual of Examining Procedure §907.  The USPTO will not issue registrations for marks covering goods or services that violate federal law – even if such goods or services are legal at the state level.  Despite the legalization of cannabis for medical use in 33 states and the legalization of cannabis for recreational use in 10 states, cannabis has been deemed illegal by the federal government under the Controlled Substances Act (“CSA”)1.  Cannabis-related marks have therefore been ineligible for federal trademark registration.

On December 20, 2018, the Agricultural Improvement Act of 2018, better known as the 2018 Farm Bill, was signed into law.  In relevant part, the 2018 Farm Bill removed “hemp”2from the CSA’s definition of marijuana, thus removing “hemp” from the list of controlled substances under the CSA and creating an avenue for federal registration of marks covering some goods and services derived from hemp.  Now, marks covering certain hemp-derived goods and services with less than 0.3% tetrahydrocannabinol (“THC”)3 may be eligible for federal registration.  However, the USPTO will continue to refuse registration when the identified goods or services in an application involve cannabis that meets the definition of marijuana and encompass activities still prohibited under the CSA.

To assist in the prosecution of trademark applications for these newly registerable goods and services, the USPTO outlined the requirements an application must meet before it may be eligible for registration for hemp-derived goods and related services.  First, the USPTO advises that only applications covering hemp-derived goods and services with less than 0.3% THC are registerable.  Second, an application’s identification of goods for all goods derived from hemp must explicitly state that the hemp-derived goods contain less than 0.3% THC.  Third, only applications for marks covering hemp-based products and related services filed after December 20, 2018, are eligible for federal registration.  Any applications filed prior to December 20, 2018, must be amended or refiled.4.  Specifically, applicants must request the USPTO amend their filing date to December 20, 2018, or withdraw their application and submit a new one.   Notably, the USPTO will also examine applications to register service marks for compliance with the CSA and the 2018 Farm Bill; and, as such, an application’s identification of services must also specify that the involved cannabis contains less than 0.3% THC on a dry weight basis.  Moreover, there are additional requirements for applications that include services involving the cultivation or production of hemp.

Restrictions still remain on the registrability of marks for hemp and hemp-derived goods.  For example, applications to register marks covering hemp-derived foods, beverages, dietary supplements, or pet treats will still be refused as unlawful because the use of hemp in items for human or animal consumption has not yet been approved by the Food and Drug Administration (“FDA”)5.

While Examination Guide 1-19 signals the budding federal registrability of marks for certain hemp-derived goods and services, applicants should consider the stringent requirements placed on the same.  Mark owners should think critically about whether their trademarks for cannabis and cannabis-related products and services are potentially eligible for federal protection, as we expect to see a significant influx of applications covering these types of offerings in the near future.  Filing applications for eligible products and services now may help mark owners gain a foothold in what will likely be a competitive business field going forward.

1 Under the Controlled Substances Act the drug class “Marihuana” (also referred to as “cannabis” or “marijuana”) is defined as “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.”  21 U.S.C. §802(16).  Cannabidiol (“CBD”), a chemical constituent of the marijuana plant is included in the Controlled Substances Act’s definition of “Marihuana.”  See id.

2 Hemp is defined as “the plant Cannabis sativa L., and any other part of that plant, including the seeds thereof an all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (“THC”) concentration of not more than 0.3% on a dry weight basis.”  Agricultural Improvement Act §297A

3 THC is the main psychoactive ingredient of cannabis.

4 The USPTO takes the position that any applications filed before December 20, 2018 lacked a valid basis to support registration at the time of filing because the applied-for goods violated federal law.  See Examination Guide 1-19: Examination of Marks for Cannabis and Cannabis Related Goods and Services after Enactment of the 2018 Farm Bill.

5 The 2018 Farm Bill specifies that the FDA retains its authority to regulate goods containing cannabis and cannabis-derived compounds, and the FDA has taken the position that cannabis-infused items for human or animal consumption require the FDA’s approval before they may be sold to consumers. The FDA is conducting clinical investigations into the safety and efficacy of such products for human and animal consumption.

© 2019 Brinks Gilson Lione. All Rights Reserved.
This post was written by Virginia Wolk Marino and Emily Kappers of  Brinks Gilson & Lione
Read more USPTO & Trademark news on the National Law Review Intellectual Property page

Federal Alcohol Regulator follows FDA, No CBD in Beer, Wine and Liquor

While hemp is now legal under state and federal law, the Alcohol and Tobacco Tax and Trade Bureau (TTB) has made clear that cannabidiol (CBD), a product derived from hemp, is not a permitted ingredient in alcohol beverages quite yet.

The use of hemp and CBD in various products has proliferated in recent months, and the public and stakeholders have looked to the Food and Drug Administration’s (FDA) and TTB for guidance.

On April 26, 2019, the TTB issued an industry circular1, making clear the TTB will look to the FDA for determinations on whether hemp ingredients such as CBD may be included in food or alcohol. The FDA recently has reiterated that CBD is not a permitted ingredient in food or dietary supplements under federal law. The FDA is, however, beginning the process of reevaluating this position which could lead to an administrative rulemaking.

Following the approach of the FDA, the TTB has stated it will not approve alcohol beverage formulas including certain hemp ingredients, including CBD. However, hemp seeds and hemp seed oil are approved ingredients as they comply with FDA regulations.

There are a couple key points to consider following the statement by the TTB:

  • All alcohol beverages sold in the United States require formula approval by the TTB, even if the alcohol is sold exclusively within a single state. In comparison, the FDA regulates interstate commerce, therefore, food, beverages and dietary supplements produced and marketed exclusively in a single state may be beyond the scope of FDA regulation (but may subject to state-specific regulations).
  • Certain alcohol beverages may still be legally marketed as containing hemp. However, those products may only contain hemp seeds or hemp seed oil. Both the TTB and the FDA have approved hemp seeds and hemp seed oil as permitted food additives or ingredients. The TTB also left open the possibility of approving other parts of the hemp plant that don’t include CBD or THC.
  • The FDA is holding a public hearing on May 31, 2019, where it is seeking data and information regarding the safety of products containing CBD. The TTB appears likely to follow the lead of whatever decision is ultimately reached by the FDA. The TTB stated it will be issuing more detailed guidance regarding CBD and hemp as well.
  • The TTB further reiterated it will not approve formulas containing marijuana, or other controlled substances.

The 2018 Farm Bill made hemp a legitimate commercial crop and removed hemp from the Controlled Substances Act. Similar legislation in Wisconsin also legalized hemp at the state level. However, hemp and its derivatives, including CBD, remain regulated products. The FDA regulates hemp and CBD as ingredients in food, dietary supplements and cosmetics. The TTB regulates alcohol beverage formulas and ingredients.

 

Copyright © 2019 Godfrey & Kahn S.C.
This post was written by Zachary Bemis of Godfrey & Kahn S.C.
Read more on TTB & FDA Hemp Regulation on the National Law Review Biotech, Food, Drug page.

FDA Takes Action Against Retailers Selling Tobacco Products to Minors

On February 7 FDA initiated enforcement action against a Miami, Florida Walgreens and a Charleston, South Carolina Circle K store for repeated sales of tobacco products to minors.  The enforcement action, called a no-tobacco-sale-order (NTSO) would prevent the individual stores from selling any tobacco product for thirty days.

In its press release, FDA noted that Walgreens is the top violator amongst pharmacies that sell tobacco products, having been cited for tobacco sales to minors during 22 percent of the retail compliance check inspections at Walgreens stores since they began in 2010.  These violations have resulted in over 1,550 warning letters and 240 civil money penalties, but this is  the first NTSO at a Walgreens store.  Other stores identified as frequent violators include Walmart (17.5 percent of inspections resulted in sales to minors violations), Dollar General (14 percent), and Rite Aid (9.6 percent).

FDA commissioner Dr. Scott Gottlieb is quoted in the press release as being “deeply disturbed” by the number and frequency of sales to minors at Walgreens stores and he called on Walgreens management to meet with him to discuss why so many Walgreens stores fail to prevent sales to minors.  Dr. Gottlieb speculated that the pharmacy setting might impact consumer perceptions regarding the safety of tobacco products.

 

© 2019 Keller and Heckman LLP.
Read more news on the FDA on the National Law Review’s Biotech, Food and Drug Type of Law page.

The Blame Game: Senators Clash with the Trump Administration

Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has once again brought focus to the issue of prescription drug prices. According to the Administration, pharmacy benefit managers (“PBMs”) and drug distributors – who President Trump has dubbed as “middlemen” – are largely to blame for higher drug prices. However, Democratic Senators, PBMs, and drug distributors have recently pushed back against the Administration’s claims, arguing that the Administration’s claims are not supported by any evidence, and, in some cases, are contrary to the core functions of PBMs and drug distributors.

Background

PBMs and drug distributors have been in the crosshairs of the Administration for several months. In a speech on May 11, 2018, President Trump outlined the American Patients First blueprint (the “Blueprint”), which outlined the approach that the Administration would pursue to lower drug prices. Among several targets for change were PBMs and drug distributors, noting that among the Administration’s top goals was “eliminating the middlemen.”[1]

The Blueprint specifically sets forth the Administration’s belief that “[b]ecause health plans, pharmacy benefit managers [], and wholesalers receive higher rebates and fees when list prices increase, there is little incentive to control list prices.”[2] The Blueprint did not, however, provide any evidence or rationale for these claims. Nevertheless, the Blueprint proposes several changes to the way that PBMs operate, including creating a fiduciary duty for PBMs, and restricting the ability of PBMs to retain a percentage of the rebate collected on behalf of health plans. The Blueprint does not, however, elaborate on the Administration’s plans for drug distributors.

United States Department of Health and Human Services (“HHS”) Secretary Alex Azar elaborated on the Blueprint’s claims during a June 12, 2018 hearing before the Senate Committee on Health, Education, Labor and Pensions, where he claimed that PBMs threatened to remove drugs from their formularies if the drug manufacturers decreased list prices.[3] Secretary Azar repeated these claims on June 26, 2018, before the Senate Committee on Finance, where he claimed that drug manufacturers who voluntarily reduced list prices would be harmed by PBMs that would prioritize competing drugs with higher prices when setting their drug formularies.[4]

Senators and Stakeholders Push Back

In a letter to Secretary Azar , Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) criticize Secretary Azar’s allegations regarding the role of PBMs in drug pricing, calling them “disturbing and serious.” [5] The Senators argue that PBMs and drug distributors hold themselves out as “key players in negotiating lower drug prices and making the market for drugs more efficient” – directly contrary to Secretary Azar’s claims.[6]

The Senators investigated Secretary Azar’s claims by reaching out to the six largest PBMs and three largest drug distributors in the United States. The PBMs unanimously indicated that they never pushed back or otherwise disadvantaged any drug manufacturer for lowering list prices. Express Scripts noted that lower list prices receive favorable formulary consideration, exactly the opposite of Secretary Azar’s claims.[7] The drug distributors gave similar answers, indicating that they did not influence or have any ability to influence the list prices for drugs. Instead, one drug distributor indicated that it negotiated fees for distribution services “agnostic of [the manufacturer’s] product pricing.”[8]

Moving Forward

The Administration appears unfazed by the questions and concerns of PBMs, drug distributors, and Democratic Senators, and has focused its attention on changes to the way PBMs operate. One manner in which PBMs aim to reduce drug prices is by negotiating rebates with drug manufacturers who want to list their products on PBM formularies. On August 17, 2018, Secretary Azar claimed that HHS has the power to eliminate rebates on prescription drug purchases. While the PBM industry contends that only Congress has the ability to change the rebate system, Secretary Azar stated that rebates were created by HHS regulations, and “[w]hat one has created by regulation, one could address by regulation.” [9]

The Secretary’s claims are likely related to a proposed rule that HHS submitted to the Office of Management and Budget (“OMB”) titled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection” on July 18, 2018.[10] The OMB is still reviewing the proposed rule, and nothing is currently known about the rule beyond its title; however, Secretary Azar’s comments indicate that the rule may be aiming to adjust or eliminate the ability of PBMs to negotiate with drug manufacturers for rebates. While it is unclear exactly what will be presented in such proposed rule, it appears likely that the Administration will continue pursuing aggressive changes to the way that PBMs operate.

[1] Kerry Dooley Young, Trump Lays Out Drug Plan, Calling for More Competition, Less ‘Global Freeloading’, Medscape (May 11, 2018)

[2] United States Department of Health & Human Services, American Patients First, The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, (May 2018)

[3] Prescription Drug Pricing, C-SPAN, (June 12, 2018)

[4] Prescription Drug Supply and Cost, C-SPAN, (June 26, 2018)

[5] Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3, Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3

[6] Id. The Pharmaceutical Care Management Association, which promotes PBMs nationwide, claims PBMs will save employers, unions, government programs, and consumers $654 on drug costs over the next decade. Pharmaceutical Care Management Association, Our Industry

[7] Senators Warren and Smith, at 4

[8] Id. at 6.

[9] Yasmeen Abutaleb, U.S. Health Secretary Says Agency Can Eliminate Drug Rebates, U.S. News, (Aug. 20, 2018)

[10] Office of Management and Budget, RIN 0936-AA08, (July 18, 2018)

 

Copyright © 2018, Sheppard Mullin Richter & Hampton LLP.

New Jersey Expands Medical Cannabis Program

On March 27, 2018, New Jersey approved a significant expansion of its medical marijuana program. Reforms include eligibility for patients with anxiety, chronic pain, migraines and Tourette’s syndrome. The move is expected to expand the number of eligible patients far beyond the current level of 18,874. Registration fees will be lowered for patients and the public registry for participating physicians abolished. Currently only 536 out of 28,000 physicians are registered in the program. The loosening of these restrictions aims to address the low rate of participation by doctors and patients relative to other comparably populated states. Medical marijuana has been legal in New Jersey since 2010.

“We are changing the restrictive culture of our medical marijuana program to make it more patient-friendly,” Governor Phil Murphy said. “We are adding five new categories of medical conditions, reducing patient and caregiver fees, and recommending changes in law so patients will be able to obtain the amount of product that they need. Some of these changes will take time, but we are committed to getting it done for all New Jersey residents who can be helped by access to medical marijuana.”

New Jersey has five dispensaries, also known as Alternative Treatment Centers (ATCs). A sixth ATC is preparing to open its doors in the near future. As a result of the reforms, these ATCs will be able to open satellite locations for the first time. In addition, the 10 percent limit on THC will be removed. “Patients should be treated as patients, not criminals. We will be guided by science,” Murphy said.

Further Legalization

Governor Murphy, a Democrat, indicated he wants to sign legislation to legalize adult use of cannabis by the end of 2018. If the legislation succeeds, analysts predict legalization will generate $1 billion of revenue in its first year.

New Jersey has two competing legalization bills under consideration in the legislature that vary regarding the proposed rate of taxation, legality of home cultivation, the number of shops permitted to operate and the level of government regulation. Political momentum for cannabis reform has been growing in the wake of successful programs in Colorado, Washington and other states. Some New Jersey legislators support legalization as a method of generating revenue required for funding other budgetary obligations.

Nationwide, 29 states have medical cannabis programs. If the pending legislation succeeds, New Jersey will be the ninth state to approve recreational use. This rapidly changing landscape of cannabis law requires a diverse array of legal services. Important areas include business formation & governance, commercial transactions, regulatory compliance, labor & employment, professional liability, product liability, intellectual property, insurance coverage and tax assistance. Because cannabis laws vary from state to state, national firms will undoubtedly lead this rapidly expanding area of specialization.

 

© 2018 Wilson Elser.
This post was written by James Cope of Wilson Elser.

Massachusetts to Require CGL and PL Coverage for All “Marijuana Establishments”

In regulations finalized just before the March 15, 2018, deadline, the Massachusetts Cannabis Control Commission (CCC) has included a provision requiring the maintenance of liability insurance or an escrow account to cover potential liabilities. This applies to all Marijuana Establishments, which include marijuana cultivators, craft marijuana cooperatives, marijuana product manufacturers, marijuana retailers, independent testing laboratories, marijuana research facilities, marijuana transporters and “any other type of licensed marijuana-related businesses,” except for medical marijuana treatment centers, which are already subject to a comprehensive regulation scheme, including a similar requirement.

Provisions

Under the new regulations, Marijuana Establishments must obtain and maintain general liability coverage with minimum limits of at least $1 million per occurrence and $2 million aggregate, and product liability insurance coverage of $1 million per occurrence and $2 million aggregate, with a maximum deductible of $5,000 per occurrence. 935 CMR 500.105(10)(a).

In the event that a Marijuana Establishment is unable to obtain the required coverage, upon providing documentation of the unavailability of coverage, the requirement may be met by the deposit of $250,000, or some other amount approved by the CCC, into an escrow account. 935 CMR 500.105(10)(b).

Any new applicant will be required to provide a description of its plan to obtain the required insurance coverage or otherwise meet the requirements of this regulation as part of the application process. 935 CMR 101(c)(5).

This insurance requirement is one of several designed to ensure the financial responsibility of marijuana businesses in the Commonwealth, including a requirement that applicants detail the amounts and sources of capital resources available to them, and a requirement that a license applicant provide documentation of a bond or other resources held in an escrow account in an amount sufficient to adequately support the dismantling and winding down of a Marijuana Establishment pursuant to 935 CMR 500.101(1)(a).

Synopsis

The recreational marijuana business regulations were approved on March 9, 2018, after extensive hearings and public input. The regulations must be signed by the Secretary of the Commonwealth and published in the Massachusetts Register, which is expected to take place on March 23, 2018. The regulations become effective upon publication.

Massachusetts voters approved the legalization of recreational marijuana via ballot in November 2016. The CCC plans to begin accepting applications on April 1, 2018, and recreational marijuana sales are expected to begin on July 1, 2018. Existing medical marijuana treatment centers have been given priority for licensure in towns and cities where the number of licenses is limited, see MGL c. 94G, § 5(c), and already will have these coverages in place. However, as applications will be reviewed on a rolling basis, we would expect to see the number of businesses seeking this coverage only increasing.

 

© 2018 Wilson Elser
This post was written by Kara Thorvaldsen of Wilson Elser.

Department of Justice Announces Task Force to Combat Prescription Opioid Crisis

Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis.  According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct.  This significant step may result in greater oversight and widespread criminal and civil prosecutions.

Prescription opioids, such as oxycodone, hydrocodone and morphine, are powerful pain-reducing drugs, but may also trigger feelings of pleasure or a “high.”  Prolonged use of opioids can lead to addiction, misuse and abuse.  According to the United States Department of Health and Human Services (HHS), an estimated 64,000 Americans died of drug overdoses in 2016, with the vast majority the result of opioids – nearly 116 people lost their lives to opioids each day.  HHS declared a public health emergency in 2017, and followed with a strategic plan to improve access to prevention, treatment and support services to address it.  The PIL Task Force will work in conjunction with HHS to provide additional federal resources to address the problem.

At the manufacturer level, the PIL Task Force will examine existing state and local government lawsuits against opioid manufacturers to determine what, if any, federal assistance can be provided.  One example is already underway: Justice will file a statement of interest in the pending multi-district federal litigation in Ohio, which focuses on the improper marketing and distribution of prescription medications by manufacturers and distributors.  Justice will argue the federal government has borne substantial costs arising from the opioid epidemic and is entitled to reimbursement.

The PIL Task Force will also rely on existing laws to hold distributors, pharmacies and prescribers accountable for unlawful actions.  This work was underway even before the Task Force’s inception.  In 2015, for example, a grand jury returned a multicount indictment against Little Rock, Arkansas physician Dr. Richard Johns for unnecessarily prescribing oxycodone to patients, including to some patients he had neither examined nor met.  Johns later pleaded guilty to a single count of conspiring to possess with the intent to distribute oxycodone through a plea deal and received a nine-year federal prison sentence.

Finally, Attorney General Sessions directed the PIL Task Force to establish 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; (3) recommend changes to laws.

The Attorney General was clear: “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

The PIL Task Force is another example of federal, state and local actions to address the opioid epidemic, which may significantly impact the health care industry.  Dinsmore & Shohl is monitoring the situation and stands ready to assist clients in navigating these developments.

National Institute on Drug Abuse, Opioid Overdose Crisis (Feb. 2018)

U.S. Department of Justice, Attorney General Sessions Delivers Remarks Announcing the prescription Interdiction and Litigation Task Force (Feb. 27, 2018).

U.S. Department of Justice, Justice Department to File Statement of Interest in Opioid Case (Feb. 27, 2018),

U.S. Department of Health & Human Services, HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis (Oct. 26, 2017).

 

© 2018 Dinsmore & Shohl LLP. All rights reserved.

Mild Traumatic Brain Injury and the Pupillary Light Reflex

According to a recent review study of Pubmed Central/National Library of Medicine databases, the pupillary light reflex provides an optimal opportunity to investigate mild traumatic brain injury (mTBI).

Based on the findings of the review, the pupillary system may provide a noninvasive “window” to mTBI, in terms of documenting its existence and the often-accompanying symptom of photosensitivity. When an individual experiences mTBI, visual dysfunction may occur, and the pupillary light reflex may be affected. Pupils are routinely assessed for abnormal size and responsivity to determine the neural integrity of the visual system. Investigating pupillary light reflex in the mTBI population, researchers found that pupillary response was significantly delayed, slowed, and reduced, symmetrically, with a smaller baseline diameter. These findings may indicate dysfunction of the pupillary pathway.

Several objective biomarkers for the presence of mTBI and photosensitivity provide further insight into neurological dysfunction. In mTBI, photosensitivity may be due to dysfunction in the baseline neural sensor. Photosensitivity as a perceptual phenomenon can be confirmed through objective, noninvasive, rapid, vision-based, pupillary biomarkers.

Pupillary light reflex in mTBI may be investigated with pupillometers to assess subtle abnormalities in pupil size as well as pupillary responses. The resulting information can provide diagnostic or prognostic indicators relating to the extent of the injury, and neurophysiological linkages. Pupillometers offer precise and extensive pupillary testing for the mTBI population, especially those individuals who experience photosensitivity. The major drawback is cost. Development of a more inexpensive hand-held pupillometer would help with diagnosis of mTBI and improve patient care.

With such instrumentation, pupillary light reflex could be used to investigate the possibility of a very early, acute-stage mTBI/concussion in emergency rooms, in the workplace, and even on the sideline of sports games. Such information can be relevant to a worker’s compensation determinations, social security disability determinations, and return-to-play/work/learn standards for both adults and children.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Biotech legal analysis, go to The National Law Review