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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 In 2023, the FDA issued its first-ever AI/ML device draft guidance, aiming to provide a forward-thinking approach to the development of machine learning-enabled device software functions.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.

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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.

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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.
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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.
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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.
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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.
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Alert

VIDEO: TBCE Stem Cell Stakeholder meeting

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

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Presentation

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.

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Alert

FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, however, that just because a manufacturer has knowledge that health care providers prescribe or use the product for an unapproved use, does not establish a new “intended use” for the product.

Source: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

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Alert

FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests

The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.

Source: FAQs on Laboratory Developed Tests (LDT)