James Erickson’s Post

The FDA recently issued a final rule to strengthen oversight of laboratory developed tests (LDTs), also known as in vitro diagnostics (IVDs). These tests are created and used within a single clinical laboratory. The new rule explicitly places IVDs, even when produced by laboratories, under the Federal Food, Drug, and Cosmetic Act, making them subject to increased FDA regulatory oversight. While the FDA emphasizes the importance of reliable LDT results in the interest of patient safety, the American Clinical Laboratory Association (ACLA) opposes the rule, arguing that LDTs are not medical devices and subjecting them to regulation will impede patient access to essential testing in remote or at-home settings. However, Jana Care remain enthusiastic about our progress to deliver the first FDA cleared, at-home blood testing platform for patients with heart failure and chronic kidney disease. Highlights of the final rule include: Phasing out lenient enforcement: The FDA will no longer exercise leniency in enforcing regulations for LDTs. Lab-manufactured tests will now be subject to the same enforcement policies as other tests. Regulation as medical devices: Most LDTs will now be regulated as medical devices, aligning them with other in vitro diagnostics and requiring pre-market review. Motivation behind the rule: The FDA recognizes that LDTs’ risks have increased due to their complexity and widespread use. They believe greater safeguards are necessary. https://lnkd.in/eysanFET

RSV Vaccine ABRYSVO Shows Strong Immune Response in Immunocompromised Adults Pfizer announced promising results from a Phase 3 clinical trial of their RSV vaccine, ABRYSVO, specifically targeting immunocompromised adults aged 18 and older. ABRYSVO demonstrated a strong neutralizing response and consistent safety profile with just a single 120 µg dose across all age groups. Dr. Annaliesa A., Pfizer's Senior Vice President and Chief Scientific Officer of Vaccine Research and Development, highlighted the vaccine's potential to address a significant gap in RSV protection for this vulnerable population. Pfizer plans to present these findings at scientific conferences, submit them for regulatory review, and further enhance the vaccine's accessibility with the FDA-approved ACT-O-VIAL® presentation. For more details please click the link! https://lnkd.in/dTGRwtY4 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

📜 Two Court challenges to FDA's (asserted) jurisdiction to regulate Laboratory Developed Tests (LDTs) as medical devices❓❓❓❓ 📎 American Clinical Laboratories Association v FDA - filed 29 May, 2024 (ACLA) 🖇 Association for Molecular Pathology v FDA - filed 19 August, 2024 (AMP) 🏜 Both filed in Texas (Eastern and Southern districts, respectively) 📜 Links to the complaints in the comments 🔭 'LDT's are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single laboratory...[and] are intended for use in the collection, preparation, and examination of specimens taken from the human body...to provide information about a patient's health, including to diagnose, monitor, or determine treatment for diseases and conditions'. 🔬 Both argue, amongst other things, that LDTs are not medical devices because they are not physical products and instead are professional healthcare services. Further, they are not commercially distributed for third party use. 😅 Both contend that Clinical Laboratory Improvement Amendments of 1988 (CLIA) covers the field. Congress has clearly indicated that LDT's are not to be regulated as medical devices, or by the FDA under the Food, Drug and Cosmetic Act (FDCA). In addition to the CLIA, reference is made to Congress's failure to pass a specific law three times to regulate LDTs under the FDCA. 🤯 Both invoke the "major questions doctrine", 'under which courts expect Congress to speak clearly if it wishes to assign to an agency decisions of vast economic and political significance': West Virginia, 597 U.S. at 716 🚬 AMP likens the FDA's final rule to its attempt to regulate Tobacco (see Brown & Williamson, 529 U.S. at 131 and paras [138] and [139]) and contends that the scope of the case is narrow: 'Whether the FDCA clearly and unambiguously authorizes FDA to regulate LDTs under the FDCA'. 🏮 ACLA does not draw this comparison. 🏥 AMP also contends that the FDA's final rule 'eviscerates' the FDCA's practice of medicine exemption in 21 USC § 360(g)(2). ACLA does not directly make this point. Interestingly also, is AMP's argument at [140] that more than a vaguely worded definition [of medical device] is required for clear congressional authorization [for the purposes of the major questions doctrine]. I think FDA may lose both cases if they proceed. It will be interesting to follow.

Here we compare the new Opvee, an opioid antagonist for an overdose, to Narcan #pharmacy #pharmacology #opioids #overdose https://lnkd.in/gR5dmKhB

A proposed rule that would change U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests may have negative effects on #CancerCare and innovation in #Oncology, according to critics. The FDA is proposing that laboratory-developed tests be classified as medical devices under the Federal Food, Drug, and Cosmetic Act. This act was amended in 1976 to create a system for regulating medical devices, but the requirements for these devices have generally not applied to laboratory-developed tests. Under the new proposed rule, the FDA would phase out the general enforcement discretion approach currently used for laboratory-developed tests and adopt the same enforcement approach used for other in vitro diagnostics (IVDs) to “better protect the public health by helping to assure the safety and effectiveness” of laboratory-developed tests. Read here: https://brnw.ch/21wHKfl #LaboratoryDevelopedTests #InVitroDiagnostics #PublicHealth

FDA Issues Draft Guidance on Diversity Action Plans for Clinical Trials! On June 26, the U.S. Food and Drug Administration (FDA) released a pivotal draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance aims to support medical product sponsors in submitting Diversity Action Plans for clinical studies involving drugs, biological products, and devices. Here are the key takeaways and recommended actions: Mandatory Diversity Action Plans Sponsors conducting certain phase 3 clinical studies for new drugs, or pivotal clinical studies for devices, must submit Diversity Action Plans to the FDA. This is in line with sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act. Goals and Rationale Plans should outline specific enrollment goals for underrepresented populations based on race, ethnicity, sex, and age. Sponsors must provide a rationale for these goals, considering factors like disease prevalence and the demographic characteristics of the intended use population. Strategies for Enrollment Effective strategies include community engagement, cultural competency training, reducing participant burden, and improving study accessibility. Monitoring and adjusting these strategies throughout the study is crucial to meet enrollment targets. Submission Timelines Sponsors are encouraged to submit Diversity Action Plans early in the clinical development process. The FDA recommends incorporating diversity strategies across all phases of clinical development when possible. Public Transparency Key elements of the Diversity Action Plans should be publicly posted to enhance transparency and accountability. Recommended Actions for Sponsors: Create detailed Diversity Action Plans addressing enrollment goals, strategies for reaching underrepresented populations, and monitoring mechanisms; work with community advisory boards, patient advocacy groups, and local healthcare providers to build trust and facilitate participation; train clinical investigators and staff to engage effectively with diverse populations and address potential biases; simplify study-related procedures, offer flexible scheduling, and provide support like transportation and dependent care to participants; and incorporate diversity considerations from the early stages of clinical development to ensure broad and representative participation.

We are happy to share the findings of our recently published study titled "Clinical Pharmacology Consultation for Better Patient Care: A Single-Center Audit" in the Journal of Modern Medicine (JOMM). This audit was conducted at a specialized Clinical Pharmacology clinic, with the aim of evaluating how clinical pharmacology consultations can improve patient care and outcomes, particularly in cases involving complex medication regimens. The study, which enrolled 224 participants, revealed some compelling insights: 1. Polypharmacy was the leading cause for seeking consultations, accounting for 21.4% of cases, followed by concerns related to glycemic fluctuations (11.2%), drug allergies in relation to COVID-19 vaccination (10.7%), and drug rashes (10.3%). 2. An initial Patient Satisfaction Score (PSS) of 65.38% was recorded at baseline, which rose to an overall mean of 69.42% after consultation. 3. The study revealed that 95% of patients showed significant clinical improvement following consultations, affirming the critical role clinical pharmacology plays in enhancing patient care. 4. Follow-up visits played a role in this improvement, with a weak but positive correlation observed between the follow-up latency and changes in the PSS score (r = 0.351). These findings underscore the need to establish more Clinical Pharmacology clinics nationwide. In today's healthcare environment, where medication regimens are increasingly complex, clinical pharmacologists are uniquely equipped to optimize treatment outcomes, reduce adverse drug reactions, and ensure safer use of medications. We take this opportunity to express our heartfelt thanks to Prof. Santanu K. Tripathi for his continuous support, guidance, and enthusiasm in advancing the idea of Clinical Pharmacology clinics. His contributions have been invaluable in making this initiative a reality, and we hope this study will inspire broader adoption of clinical pharmacology consultations across healthcare institutions in India. By expanding Clinical Pharmacology clinics, we can enhance healthcare outcomes, address the challenges of polypharmacy, and ensure patients receive the most effective and safe treatments. For further details, we invite you to explore our full study - https://lnkd.in/dnPJrNrn #clinicalpharmacology #therapeutics #pharmacology

The FDA, specifically OHT7, has been pointing companies to decision summaries that contain guidelines rather than issuing special control for IVDs that have been granted a de novo authorization. Today, they have released two FR notices classifying "Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens." Will a special controls document follow? medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and

🌟 Excited to share that our research has been published in a renowned Q1 international journal! 🎉 The study is open access and available here: https://lnkd.in/e4f55A5d Our research focuses on Drug Therapy Related Problems (DTRPs) in a tertiary care hospital in Nepal. The findings provide critical insights for researchers and policymakers, highlighting the urgent need for clinical pharmacists in healthcare wards. 📊💊 Key highlights from the study include: 1️⃣ High prevalence of DTRPs (77.4%), with most being preventable through clinical pharmacist integration into healthcare systems. 2️⃣ Leading causes of DTRPs: Drug selection issues (40.47%) Treatment duration errors (16.71%) Dispensing errors (15.75%) Dose selection problems (13.12%) 3️⃣ Primary contributing factors: Non-adherence to evidence-based medicine (EBM) and established guidelines. 4️⃣ Antibiotics emerged as a significant source of DTRPs, often prescribed against local/national antimicrobial guidelines or without valid indications. 5️⃣ Widespread issues of irrational drug use and therapeutic duplications. 6️⃣ Factors explaining the high prevalence of DTRPs: Lack of monitoring and documentation Multiple prescribers Absence of clinical pharmacists in line with Nepal's Hospital Pharmacy Guideline 2072. 7️⃣ Dispensing errors stemmed from the lack of counselling services, dedicated spaces, qualified pharmacists, and clinical pharmacy services in wards. 8️⃣ Nearly all patients were unaware or incorrectly using special medicine delivery devices (e.g., Meter Dose Inhalers, Rotahaler, Insulin Pens), underlining the importance of pharmacist-led counselling. 9️⃣ Patients often failed to receive medication for chronic diseases due to insufficient history-taking in the absence of pharmacy experts. 🔟 Therapeutic drug monitoring (TDM) for narrow therapeutic index drugs (e.g., Warfarin, lithium carbonate, digoxin, vancomycin) was inadequate due to unavailable facilities. 1️⃣1️⃣ Geriatric and polypharmacy patients require special attention. These findings underscore the critical need for qualified clinical pharmacists in hospital wards to improve patient outcomes and reduce preventable DTRPs. 💡 📢 Let’s collaborate to promote safer, evidence-based practices in clinical pharmacy! #ClinicalPharmacy #ResearchPublication #DrugTherapy #HealthcareInnovation #PharmacyCare #PatientSafety #OpenAccessResearch