Tag: Drug & Device

Categories
Health Law Highlights

People Are Overdosing on Off-Brand Weight-Loss Drugs, FDA Warns

Summary of article from Ars Technica, by Beth Mole:

The FDA has issued a warning about overdoses related to off-brand versions of the weight-loss drug semaglutide, commonly known as Wegovy and Ozempic. Due to high costs and supply shortages, patients are turning to compounded versions, which lack standardized dosing and safety assurances. These compounded drugs often come with unclear instructions and improper syringe sizes, leading to significant dosing errors—sometimes up to 20 times the intended amount. Such overdoses have resulted in severe health issues, including nausea, vomiting, and pancreatitis. The FDA emphasizes that compounded drugs carry higher risks and should only be used when absolutely necessary. The agency also noted that healthcare providers have made dosage calculation errors, further exacerbating the problem.

Categories
Health Law Highlights

6 Steps to Release a Medical IoT Device

Summary of article from Edge Industry Review, by Gilad David Maayan:

Releasing a medical IoT device involves a detailed process to ensure its effectiveness, compliance, and market viability. The first step is conducting market research to assess demand, compare with competitors, and evaluate market size and acceptance, guiding stakeholders on investment decisions. Regulatory planning is crucial, requiring familiarity with laws like the EU MDR and FDA regulations to define the device’s use and ensure compliance.

Design controls must be documented throughout development, adhering to standards such as ISO 13485 to maintain product quality. Establishing a tailored Quality Management System (QMS) addresses design, risk, and supply chain management, ensuring compliance with relevant standards. Clinical evaluation demonstrates the device’s safety and efficacy through trials or literature review, summarizing risks and benefits.

Postmarket surveillance is essential for ongoing monitoring of the device’s performance, ensuring long-term safety and effectiveness, and complying with stringent regulations. Edge computing enhances medical IoT devices by enabling local data processing, which speeds up analysis and response times, reduces reliance on internet connectivity, and ensures functionality in remote areas. Key considerations include hardware capabilities, data security, interoperability, and processing speed, all vital for timely healthcare decisions.

The Internet of Medical Things (IoMT) is transforming healthcare by providing personalized, detailed treatment outside hospitals. Despite the complexity of development and regulatory approval, these devices offer significant potential for improved patient outcomes and profitability.

Categories
Health Law Highlights

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

Summary of article from Foley Hoag LLP, by Patrick Brennan, Andrew London, Ross Margulies, Kian Azimpoor:

On May 21, 2024, the U.S. Court of Appeals for the District of Columbia Circuit affirmed a lower court’s decision in United Therapeutics Corporation v. Carole Johnson and Novartis Pharmaceuticals v. Carole Johnson, rejecting the government’s position that the 340B statute prohibits drug manufacturers from imposing contractual conditions on drug distribution. The court upheld that the manufacturers’ conditions imposed on contract pharmacies did not violate the 340B statute, but noted that some restrictions might. This follows a similar decision by the Third Circuit in Sanofi Aventis U.S. LLC v. HHS. There is still an ongoing case in the Seventh Circuit that could influence whether the case goes to the Supreme Court or if the Health Resources and Services Administration (HRSA) reconsiders its contract pharmacy policy. This decision is a significant win for drug manufacturers, but its immediate impact on the Section 340B program remains uncertain pending other appellate court rulings and potential Supreme Court review.

Categories
Health Law Highlights

How State-Level Psychedelic Medicine Legislation Raises Equity Concerns

Summary of article from Healthcare Brew, by Maia Anderson:

The FDA is likely to decide on the approval of an MDMA-based psychedelic medicine this year, with multiple states considering legalization for therapeutic use. However, there is concern about equitable access to these treatments. Psilocybin, MDMA, and a form of LSD have been granted breakthrough therapy status by the FDA, allowing for clinical trials for potential therapeutic uses. States are taking varied approaches to legislation, with some legalizing or decriminalizing psychedelics and others allowing research. There are concerns about the high cost of these therapies and their accessibility, particularly for people of color, with initiatives ongoing to educate clinicians and develop non-hallucinogenic variants to increase accessibility.

Categories
Health Law Highlights

Louisiana Lawmakers Pass Bill Making Abortion Pills Controlled Dangerous Substances

Summary of article from AP News, by Sara Cline:

Louisiana is set to reclassify abortion-inducing drugs, mifepristone and misoprostol, as controlled and dangerous substances under a new bill that has received final legislative approval. Supporters of the bill argue it will protect women from coerced abortions, while critics, including numerous doctors, fear it will hamper their ability to prescribe these medicines for other reproductive health needs. The bill would place these drugs on the list of Schedule IV drugs under the state’s Uniform Controlled Dangerous Substances Law, requiring doctors to have a specific license to prescribe them and the drugs to be stored in certain facilities. Critics warn this could create barriers to treatment and cause unnecessary fear and confusion. The bill now awaits the signature of the conservative Republican Governor Jeff Landry, who has indicated his support.

Categories
Health Law Highlights

US DEA Will Reclassify Marijuana, Ease Restrictions

Summary of article from AP News, by Zeke Miller, Joshua Goodman, Jim Mustian, Lindsay Whitehurst:

The U.S. Drug Enforcement Administration (DEA) plans to reclassify marijuana as a less dangerous drug, recognizing its medical uses and lower potential for abuse. The proposal, pending review by the White House Office of Management and Budget, would move marijuana from a Schedule I to a Schedule III drug but would not legalize it for recreational use. This change follows President Biden’s call for a review of federal marijuana law and his efforts to pardon Americans convicted of simple possession. Critics argue the move could lead to harmful side effects and that marijuana should be treated like alcohol instead. Despite the change, marijuana would still be a controlled substance and subject to federal regulations.

Categories
Health Law Highlights

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

Summary of article from Jones Day, by Maureen Bennett, Ryan Blaney, Alexis Gilroy, Colleen Heisey, Michael McFerran, Lauren Murtagh:

The U.S. Food and Drug Administration (FDA) has proposed an updated draft Premarket Cybersecurity Guidance on March 13, 2024, to aid in meeting cybersecurity requirements for FDA medical device submissions. This guidance, under Section 524B of the Federal Food, Drug, and Cosmetic Act, applies to any submission for a “Cyber Device”, which is defined as any device containing software, with potential internet connectivity, and susceptibility to cybersecurity threats. Manufacturers are required to provide documentation that includes plans for dealing with cybersecurity vulnerabilities, assurance of device and system security, and a detailed software bill of materials. The guidance also addresses the impact of device modifications on cybersecurity and the need for a “reasonable assurance of cybersecurity” in the device’s safety and effectiveness evaluation. The FDA will finalize the draft guidance after considering comments and suggestions submitted by May 13, 2024.

Categories
Health Law Highlights

Ozempic’s Success Treating Other Ailments Is Bad News for Rivals

From Bloomberg Law, by Madison Muller:

  • Ozempic, and other GLP-1 receptor agonists, are diabetes medications that have become popular for weight loss.
  • Now, there is evidence that they have other more far-reaching benefits too:
    • They may have a protective effect on the heart, liver and kidneys.
    • They may combat substance abuse or even Alzheimer’s disease.
    • Wegovy has been shown to reduce the risk of heart attacks and strokes by 20% in overweight people with a history of heart issues.
  • As a result, these medications may disrupt many different industries.
  • For example, when the manufacturer of Ozempic announced on Oct. 10 that its effectiveness in kidney disease was so conclusive that it was stopping a trial early, it sparked a $3.6 billion selloff in shares of dialysis providers Fresenius Medical Care AG and DaVita Inc.
  • These drugs may also disrupt the health insurance market. Even if approved for new uses, these drugs are very expensivThe list price for Ozempic is about $900 a month, and for Wegovy it’s more than $1,000.
Categories
Alert

Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).

Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a medical practitioner to conduct at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. There are seven exceptions, one of which is during a public health emergency.

For the past three years, many telehealth providers have become accustomed to prescribing controlled substances following a telehealth visit, without first conducting an in-person exam.

With the PHE coming to an end in May, an in-person exam will be required. However, the Drug Enforcement Agency (DEA) has proposed rules to that will create additional flexibilities on the timing and manner for obtaining an in-person exam.

Federal Register

Categories
Highlight

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

As the title implies, this final rule clarifies and amends the discount safe harbor at 42 C.F.R. § 1001.925(h) under the federal Anti-kickback statute (AKS) such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe harbor. The rule also adds a new safe harbor for point-of-sale reductions in price that are passed on directly to a buyer (a defined term under the rule) and an additional safe harbor for “legitimate” service fees paid to PBMs by drug manufacturers.

Source: OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees