In the life sciences industry, continued enforcement activity has placed a premium on sophisticated compliance programs, calibrated to a company’s risk profile. Our lawyers design, implement, and monitor comprehensive compliance solutions for clients of all types and sizes, across the entire spectrum of the life sciences industry. Backed by a deep bench of lawyers and consultants, we bring a wealth of experience, technical know-how, and a broad perspective on our clients’ specific compliance risks.
Compliance for the Real World
A compliance program is never cookie-cutter. Our clients trust us to design right-sized programs, consistent with the U.S. Department of Health and Human Services Office of Inspector General’s Seven Elements of Effective Compliance Programs, yet aligned with their real-world operations and risks and adaptable as their business grows. We assess the host of factors that drive these risks and help create the policies, procedures, and communication channels that mitigate them.
Compliance Tailored to Risk
Many of our clients are on the leading edge of technologies so new, the regulatory framework for their products are still evolving. Especially in areas with small patient populations and expensive new therapies, these innovative technologies demand unique relationships with the health care entities administering the products and novel programs to facilitate patient access to lifesaving therapies. As clear guidance from regulatory and enforcement agencies tends to lag behind the demand for these programs, it can be difficult to assess compliance risk as these programs are being implemented. Our clients turn to us to realistically assess their risks and build and implement compliance programs that are practical, forward-thinking, and fully supportive of their values and ethics.
Compliance Reflecting the Enforcement Landscape
As government enforcement priorities change in response to market forces, companies are under increased pressure to adjust their compliance policies accordingly. Especially at the state level, issues of privacy, transparency, and price reporting are receiving closer scrutiny, with more resources devoted to fraud investigations. We help clients to keep up with the enforcement landscape as it evolves, and to integrate new enforcement realities with their existing compliance structures.
- Developed and reviewed corporate compliance programs for federal contractors, and direct and indirect providers of health care services, including manufacturers of drugs, devices, and biologicals.
- Conducted effectiveness reviews of corporate compliance programs, and assisted in the development and implementation of work plans to address opportunities for improvement.
- Developed and delivered training modules on legal and regulatory requirements for federal government contractors across the life sciences spectrum to satisfy annual or compliance training requirements.