Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance documents and internal budget pressures. They need to continually update their programs to stay abreast of those developments, including revisions that target in-house processes to encourage disclosures from whistleblowers. Failure to provide for such revisions places both a company and individuals at risk Whistleblower Protection Expanded and Includes Rewards In response…
Author Archives: David Restaino, Esq.
Creating a Corporate Compliance Program
Regulatory compliance is an evolving concept that must be flexible enough to adapt to both a company’s unique business climate and to changing regulatory circumstances. Although standard operating procedures (SOPs) are a compliance tool and can and should be strongly recommended, they cannot become the end of a process. Compliance is not a set of standards or procedures that sit on a shelf until something goes wrong. Instead, compliance requires thought in creating a code of conduct and…
Biopharmaceutical and Medical Device Compliance
Off-label marketing occurs when doctors prescribe a drug or device for a use that has not received FDA approval (1). Physicians have the unfettered right to prescribe the best drugs or devices for their patients, including approved drugs and devices for unapproved uses. Pharmaceutical and medical device manufacturers, however, cannot promote their products for such uses — even if those are supported in medical literature. Companies cross the line when their sales representatives sell physicians on the idea of using…
Biopharmaceutical and Medical Device Compliance
Almost every aspect of the biopharmaceutical and medical device industries raises regulatory compliance concerns. Heightened scrutiny is required across product lifecycles — from clinical trials to manufacturing, pricing, formulary placement, and promotional practices. Those areas (as well as patient privacy and adverse event reporting) require close attention to and compliance with healthcare laws, regulations, and guidelines. Part 1 of this two-part article describes statutes, regulations, and guidances applicable to the biopharmaceutical and medical device industries. Anti-Kickback and False Claim Laws…