Author Archives: Leslie Gladstone Restaino, Esq.

The Virtual Pharmaceutical Company: A New Pathway to Market?

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In our modern biopharmaceutical industry, the maxim “bigger is always better†no longer applies. The industry’s modest virtual model persists in its popularity, emerging as a contemporary method of workplace efficiency. With an absence of manufacturing, virtual biopharmaceutical companies have found themselves unburdened by the multiple layers of bureaucracy that often plague large companies. With such freedom, they have operated much more efficiently in terms of time, resources, product specialization, and finances. As a result, virtual biopharmaceutical companies are growing…

September 15, 2016

Outsourced Data Integrity: Are Short-Term Financial Gains Worth Long-Term Headaches?

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Competitive pricing and continued cost pressures have contributed to the need for many US biopharmaceutical companies to outsource manufacture of active pharmaceutical ingredients (API) and finished products from countries with lower costs for labor, material, and equipment. The main benefit of doing so is lower costs of manufacturing with quality standards comparable to those found in the United States. India and China now account for 80% of API production. But those countries have received media attention because of biopharmaceutical manufacturing…

April 14, 2015

Encouraging In-House Disclosures In a Whistleblower’s World

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    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…

December 1, 2012

Creating a Corporate Compliance Program

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    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…

September 1, 2012

Biopharmaceutical and Medical Device Compliance

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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…

April 1, 2012

Biopharmaceutical and Medical Device Compliance

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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…

March 1, 2012