Health Law Highlights

Bogus Botox Poisoning Outbreak Spreads to 9 States, CDC Says

Summary of article from Ars Technica, by Beth Mole:

The Centers for Disease Control and Prevention (CDC) reported that 19 women across nine US states have been poisoned by counterfeit Botox injections. Almost half of these cases resulted in hospitalization, with four individuals treated with botulinum anti-toxin. The Food and Drug Administration (FDA) reported these fake products were administered by unlicensed or untrained individuals in non-medical or unlicensed settings.The FDA and CDC noted symptoms from the counterfeit injections similar to botulism, including blurred vision, difficulty swallowing, dry mouth, constipation, and muscle weakness. They advised anyone experiencing these symptoms to seek immediate medical attention.The counterfeit Botox was primarily used for cosmetic purposes by women aged between 25 and 59. Exposure to the counterfeit product can lead to botulism or similar illnesses, potentially resulting in muscle paralysis or even death.


The Compounding Problems of Semaglutide, the Miracle Weight-Loss Drug

Semaglutide weight loss drugs are quite literally saving people’s lives. There are so many health benefits to losing weight that demand for the drugs is off the charts. Demand is so high that the manufacturer can’t keep up and the drugs are in short supply.

Where there is money to be made, there will be people willing to step in. Enter compounding pharmacies, who are catering to the demand by creating supposed duplicates of the drug.

But not all semaglutide is created equally, and concerns are rising that some pharmacies are creating inferior versions of the drug that are, at best, less effective or, at worst, dangerous.

How does semaglutide work?

Ozempic was approved by the U.S. Food and Drug Administration (FDA) in 2017 for use in adults with type 2 diabetes. After patients reported significant weight loss, Novo Nordisk rebranded the drug as Wegovy and received FDA approval in 2021 for use in chronic weight management in adults.

Semaglutide, the active ingredient for both drugs, mimics the function of a hormone that is naturally produced in the body. This hormone, released into the blood after you eat, helps lower blood sugar by stimulating insulin production, decreasing the amount of glycogen created in the liver, and ultimately making you feel fuller longer.

In short supply

These drugs work really, really well. So well, in fact, physicians prescribe Ozempic, the diabetes drug, “off-label” for weight loss. The manufacturer cannot make them fast enough due to a shortage of semaglutide. Both Ozempic and Wegovy have been on the FDA shortage list since March 2022.

This creates an attractive opportunity for compounding pharmacies. As long as the drugs stay on the official shortage list, they can be copied by compounders without fear of patent infringement.

And copy them they do. But how well?

Base or salt?

Ozempic and Wegovy use the base form of semaglutide. The base form has been approved by the FDA for the treatment of diabetes and obesity. But some compounding pharmacies are using different forms of semaglutide, known as semaglutide “salts,” that are chemically different from the base version.

Semaglutide salts have not been approved by the FDA, leading some authorities to caution patients about the efficacy or safety of the variant.

The FDA has received adverse reports from some patients after using the compounded semaglutide, which prompted them to send a public letter to the National Association of Boards of Pharmacy expressing agency concerns with the use of the salt forms of the compounded products. Some state pharmacy boards have also voiced concern.

The manufacturer of the brand-named drugs is making waves, too, and in some cases, threatening and filing lawsuits against pharmacies compounding the drugs and the health care providers administering them.

Best practices

Although the manufacturer is trying to step up production, the demand for semaglutide products will likely continue to outstrip the supply for the foreseeable future. Undoubtedly, many patients and their providers will turn to compounded variants to meet demand.

A physician’s responsibility goes beyond just prescribing the drug. They should understand how the drug is compounded and investigate the efficacy and safety of the salt forms of the product. Then decide if the salt form is appropriate for their patients.

If it is, providers should inform their patients. The Texas Medical Board considers the administration of non-FDA-approved drugs to be a form of alternative medicine. Medical board rules require that patients be informed that the drug is not FDA-approved and be told of the risks associated with the drug.

Pharmacies, too, play a key role as the backbone of our medication dispensing infrastructure. They should stay abreast of the regulations governing the compounding of semaglutide and the ethical considerations of preparing a medication for an individual patient.

They should follow the United States Pharmacopeia (USP) standards. Maintain a clean and safe environment, train personnel, appropriately label the medications, accurately identify the active ingredients, and provide accurate use instructions.

Patients have a responsibility, too. Talk to your doctor and discuss the risks and benefits of the compounded drug. If you and your doctor decide the drug is right for you, keep the lines of communication open with your physician and disclose any adverse reactions as soon as possible.

The future

The demand for these weight loss drugs will remain high for the foreseeable future. Until supply catches up with demand, growing pains will be felt in all corners of our healthcare delivery system.

From the companies that manufacture and compound the drugs to the physicians who prescribe them, the patients who take them, to the insurers who will be asked to pay for them – everyone has a responsible role to play.

Health Law Highlights

The FDA and the Future of AI Oversight

From Manatt, Phelps & Phillips, LLP, by Nicholas Bath Jr., Rachel Sher, Daniel Weinstein:

The U.S. Government Accountability Office (GAO) issued a report in January 2024 highlighting challenges faced by the U.S. Food and Drug Administration (FDA) in effectively regulating artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging health care technologies. The report emphasized the need for clear regulations that balance safety, transparency, consumer protection, and innovation, especially considering the rapid evolution of AI/ML technology and its potential applications and risks.

Over the past five years, federal regulation of AI/ML has increased, particularly in the health care sector. In 2023, the FDA issued its first-ever AI/ML device draft guidance, aiming to provide a forward-thinking approach to the development of machine learning-enabled device software functions.

Despite the FDA’s efforts, the approach to AI/ML regulation has been criticized as uncoordinated and overly broad, potentially hindering technology development and rollout, and causing confusion among stakeholders. State legislators, regulators, and medical boards are beginning to introduce state-level policy, adding to the regulatory complexity.

Given the legislative gridlock, some stakeholders have proposed a novel approach to ensure the safety and effectiveness of AI/ML-enabled medical devices through public-private assurance laboratory partnerships. These labs would be testing grounds to validate and monitor AI/ML in medical devices. The proposal, while controversial, is expected to garner more attention in the coming months as the Congressional Bipartisan AI Task Force develops its comprehensive report and policy proposals to bolster the federal government’s ability to regulate AI/ML.

Health Law Highlights

Ozempic, Wegovy, and the New Compliance Risks for Providers

From Dentons, by Susan Freed:

Increase in Prescription of Diabetes and Obesity Drugs: There has been a significant rise in the popularity of diabetes and obesity drugs like Ozempic and Wegovy, with U.S healthcare providers writing over 9 million prescriptions in the last three months of 2022. This is a 300% increase from 2020, with almost half of the users potentially taking these medications for weight loss.

Supply and Cost Challenges: The demand for these medications has outpaced supply, making them increasingly difficult to access, especially for new patients. The high costs, ranging from $900 to $1300 per month, also limit patient access, making health insurance coverage crucial.

Compliance Risks for Providers: The popularity of these drugs, coupled with access issues, presents new compliance risks for providers. There’s a need for increased education, monitoring, and vigilance, especially in documenting medical necessity and other criteria required by insurers.

Risk Mitigation Strategies: Compliance officers should consider providing increased education to practitioners about these medications and insurance coverage requirements, implementing processes to track insurer coverage criteria, reviewing and responding to insurer requests for documentation, and monitoring prescribing habits of practitioners. If outliers are identified, a more in-depth review should be coordinated.

Drug Diversion and Theft Risks: As access to these medications becomes more difficult, the risk of drug diversion and theft increases. Healthcare providers should ensure proper safeguarding measures are in place, especially for drug samples and drug sample closets.

Health Law Highlights

FDA Warns Against Unauthorized Fat-Melting Injection Treatments

From NBC News, by Berkeley Lovelace Jr.:

  • The FDA has issued a warning about the dangers of using unauthorized versions of fat-dissolving injections, citing reports of severe side effects such as scarring, infections, and skin deformities.
  • These injections, also known as lipolysis injections, are typically used in problem areas such as the chin, legs, upper arms, and abdomen.
  • While the FDA has approved one injection, Kybella, from Kythera Biopharmaceuticals, there are many unapproved versions being sold at clinics and med spas, as well as online.
  • Common ingredients in these unapproved injections, such as phosphatidylcholine and sodium deoxycholate, have not been approved by the FDA.
  • The FDA advises against purchasing fat-dissolving products from websites, as they may be ineffective and carry a risk of severe side effects. If experiencing side effects from these injections, it is recommended to see a healthcare provider.
Health Law Highlights

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

From Foley & Lardner, LLP, by Kyle Gaget and Jordan Smiley:

  • The FDA has released a final rule regarding direct-to-consumer (DTC) advertising for prescription drugs and biologics.
  • The rule requires that DTC ads include the most important risks associated with the drug or biologic being advertised.
  • The FDA has also clarified that companies can include a “major statement” in their ads to fulfill this requirement.
  • The final rule also addresses the use of alternative media for DTC ads, such as social media and online platforms.
  • Companies are encouraged to review and update their DTC advertising practices to ensure compliance with the new rule.
Health Law Highlights

FDA Issues Revised Off-Label Communications Guidance

From Jones Day, by Anthony Dick, Harrison Farmer, Colleen Heisey, Laura Laemmle-Weidenfeld, Rebecca Martin:

  • The FDA has issued a revised draft guidance on the sharing of scientific information with healthcare providers (HCPs) regarding unapproved uses of approved/cleared medical products.
  • The 2023 Guidance expands the scope of recommendations to include independent clinical practice resources and firm-generated presentations of scientific information.
  • It introduces a new evidentiary standard for source publications and emphasizes the importance of truthful, non-misleading, factual, and unbiased communications.
  • The guidance also provides presentational considerations, such as clear disclosures, avoidance of persuasive marketing techniques, and the use of plain language.
  • Comments on the guidance can be submitted until January 5, 2024.
Health Law Highlights

False Claims Act Risks for Cyber Device Manufacturers Arising Under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

From GibsonDunn, by Winston Chan, Jonathan Phillips, Gustav Eyler, John Partridge, Christopher Rosina, Carlo Felizardo, and Nicole Waddick:

  • The FDA approval process for digital health “cyber devices” requires that premarket submissions contain cybersecurity information, including the company’s plans to address cybersecurity vulnerabilities, processes to provide a reasonable assurance that the devices are cybersecure, a software bill of materials, and other information as the Secretary requires.
  • As of October 1, 2023, the FDA expects companies to comply with these new cybersecurity requirements.
  • False statements related to these disclosures could give rise to false statements and subsequent risk based on the “fraud-on-the-FDA” theory of liability.
  • Companies should take significant care in their statements in premarket submissions regarding their cybersecurity practices and procedures.

VIDEO: TBCE Stem Cell Stakeholder meeting

Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020.


VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies

A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.