Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny from both agencies. For growing brands—especially those investing in digital marketing—regulatory compliance is essential. Aligning marketing claims with both excitement and credibility helps companies avoid enforcement risks, build consumer trust, and strengthen partnerships.

Support the show

Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed.

Key Risks to Watch Out For:

• Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results.
  
  
• Data Ownership: If not explicit, investigators may claim ownership of trial data, patient lists, or publication rights. Agreements should clarify that the site owns study data and records.
  
  
• Non-Competes & Moonlighting: Overly broad restrictions may be unenforceable, while too weak protections allow PIs to compete directly. Clauses must be narrow, specific, and tied to legitimate business interests.
  
  
• Exit Strategies: Standard agreements often miss compliance safeguards. Sites need termination rights for events like loss of medical license, federal program exclusion, FDA disqualification, or protocol non-compliance.
  
  

Takeaway:
Physician agreements are not just HR paperwork—they determine a site’s survival. Poorly drafted contracts can act like ticking time bombs. Sites should ensure agreements protect data, comply with regulations, and safeguard operations.

Support the show

In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical.

Joseph explains the importance of engaging with various business units to understand real plans, aligning training programs with compliance needs, and avoiding pitfalls that could trigger violations of federal anti-kickback statutes. He emphasizes careful management of speakers bureau rosters, evaluating the necessity and effectiveness of healthcare professionals (HCPs) on the program, and considering fair market value while avoiding indirect remuneration risks.

The conversation also covers compensation approaches, proper documentation, and the value of third-party partners for benchmarking and compliance review. Joseph stresses that each program should be tailored to the company’s unique needs and highlights the importance of ongoing evaluation, diligence, and oversight.

Reach out to learn more.

Support the show