DarshanTalks Podcast

We'll briefly discuss when a pharmacist might choose not to dispense medication, even with a valid doctor's order.
In a recent case, a doctor sued the Iowa Board of Pharmacy and the Iowa Board of Medicine when a pharmacy refused to fill a prescription for Ivermectin, a livestock drug sometimes used to treat parasites in people and allegedly COVID-19. This incident highlights a dilemma in the pharmacy world, especially post-pandemic. While pharmacists ensure the safety and appropriateness of medication, the debate around drugs like Ivermectin has spotlighted their autonomy and clinical judgment. Many states require pharmacists to act independently, determining the appropriateness of therapy in conjunction with doctors. This independent role can impact reimbursement, licensing, and job descriptions.
Switching gears, we also discuss pharmacists refusing to dispense birth control due to personal beliefs. A USA Today story exposed a scenario where a pharmacist refused to fill a birth control prescription, citing faith as the reason. Such actions raise questions about the extent to which pharmacists can exercise independent medical judgment.
Governmental authorities, like the Department of Health and Human Services, argue against pharmacists withholding medications based on personal beliefs, stating it creates barriers to essential healthcare. However, courts often decide these cases on a state-by-state basis.
As pharmacists, you're trusted to make decisions prioritizing patient care. These instances stress the traditional framework, urging a discussion on balancing professional discretion with medical guidelines. The ongoing cases and complex conversations invite deeper exploration into the ethics, laws, and evolving roles of pharmacists.

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In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work, a statement suggesting that only 20% of people benefit from these medications is misleading. Darshan emphasizes that the FDA focuses on ensuring drugs are not harmful and assesses efficacy based on their effectiveness for a sufficient number of individuals, rather than a simplistic percentage. He discusses the growing field of personalized medicine, which aims to tailor treatments to individual genetic makeups, but notes that predicting a drug's effectiveness for a specific person remains complex. Concepts like digital clones and genetic design offer hope for the future, but he advises viewers to approach these ideas with caution. Ultimately, Darshan encourages understanding the intricacies of drug efficacy while maintaining realistic expectations.

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FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines.

Let’s start with the basics: FDA Regulations and the First Amendment. The FDA’s ability to impose restrictions on speakers and content is limited by the First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balance this with constitutional protections.

Next, we discuss the CFL Guidance—focused on medical device and product communications consistent with FDA-required labeling. This guidance helps evaluate whether communications about approved products align with FDA labeling, including considerations for patient populations, usage directions, and potential harm. Despite its existence for six years, companies still face challenges due to high penalties for non-compliance and a lack of concrete steps for implementation.

We’ll also cover the FDAMA 114 Guidance, which clarifies how manufacturers can share healthcare economic information with payers about both approved and unapproved products. This guidance aims to ensure that communications are truthful, non-misleading, and based on competent and reliable scientific evidence.

Additionally, the PIE Act (Prescription Drug and Medical Device Pre-Approval Information Exchange Act) facilitates communication about investigational drugs, allowing for early planning and budgeting by providing data on clinical trial phases and anticipated approval timelines.

Finally, we’ll touch on the SIUU Guidance, which focuses on communications from firms to healthcare providers about unapproved uses of approved products. This guidance is designed to ensure that such communications are truthful and separate from promotional content, despite the complexities and scrutiny involved.

The key takeaways for medical affairs teams are to develop strategies that ensure compliance with these diverse guidelines, addressing both regulatory and legal aspects of communication. For robust support, contact the Kulkarni Law Firm, where we provide expert guidance to navigate these complex issues and ensure compliance.

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Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry.
Key topics include:

1. What is Ad Promo?
2. Chevron decision's influence on FDA/FTC
3. Should administrative agencies cite letters?
4. Can the FDA establish rules after someone challenges them?
5. Uncertainty of Compliance White Space
6. Is regulatory medical advice now just seen as a risk?

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Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.

In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led to errors and potential fraud, highlighting a crucial gap in compliance.

Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me.

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