healthcareregulations

In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:

1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA safe harbors.

2. Consistent with label guidance from the FDA: Sharing information aligning with the appropriate use of a drug or device, even if not explicitly mentioned, is legally acceptable.

3. FDAMA 114:  The guidance emphasizes sharing health economic information, including off-label data, with specific entities.

4. SIUU guidance: It introduces a nuanced framework for discussing information implying off-label use, necessitating companies' awareness of its implications.

5. Education and non-company representatives: Engaging in discussions independent of pharmaceutical companies, provide crucial avenues for off-label information sharing, avoiding FDA scrutiny.

We discuss five key legal and regulatory considerations for a digital sales force:
Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal controls, and monitoring.
 It also touches on guidance for interactions with healthcare professionals, emphasizing transparency and ethical practices.
 The SIUU guidance is discussed, emphasizing accurate and fair presentation of scientific information.
The updated CMS guidance recommends comprehensive compliance programs, promoting a culture of compliance and
Lastly, the DOJ pilot program for clawbacks in employment agreements is outlined, urging employers to review agreements, establish clear policies, and conduct due diligence.
Addressing these considerations ensures digital sales forces contribute to an ethical and responsible healthcare industry, requiring companies to stay updated and provide ongoing training.

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.

The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of these features.

Design-related recalls take center stage in the FDA's recommendations. The agency discourages choosing a predicate device that has been subject to a design-related recall. If a submitter opts for such a device, they must explicitly address how they've mitigated the safety concerns that led to the recall.

Transparency and documentation constitute the third crucial consideration. The FDA stresses the need for a detailed 510(k) summary that provides a comprehensive understanding of the basis for determining substantial equivalence.

The guidance encourages the inclusion of a narrative explanation in the 510(k) summary. This narrative should elucidate the process behind selecting the predicate device, offering transparency and insight into the decision-making process.

The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process.
 
Key steps include:
1) Develop a risk-based framework- 0:39- 1:03
2) Get pre-market clearance or approval- 1:04- 1:37
3) Quality control and quality assurance- 1:38- 2:04
4) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:21
5) Ensuring data security and patient privacy- 2:22- 2:43
6) Conducting post-market surveillance- 2:44- 3:03
7) Staying proactive in meeting new compliance requirements- 3:04- 3:20
 
For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959.
 

On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.
 
We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.
 
Beyond the broader impact on public trust, pharmacists could face specific repercussions, such as disciplinary actions from the State Board of Pharmacy. Moreover, clinic owners could be barred from participating in research activities.
 
Implementing robust internal controls and collaborating with law enforcement to identify and report suspected fraud are essential steps for pharmacists and clinic owners to safeguard themselves from legal ramifications.