Anyone who is involved with the biopharmaceutical industry and who is even half-awake knows how difficult it is for companies to navigate today's increasingly hostile legal and regulatory enforcement landscape. Most companies of any appreciable size have been subjected to one or another of a barrage of government and other enforcement activity, including: FDA Warning Letters for advertising and promotion violations; Department of Justice investigations, multi-million dollar settlements, and criminal prosecutions for “off-label” activity; Corporate Integrity Agreements imposed by the Office of the Inspector General of the Department of Health and Human Services; “voluntary” settlement agreements with State Attorneys General that impose broad-ranging prohibitions and affirmative requirements in connection with a company's promotional activities; consumer fraud and products liability class action litigation; and on and on and on. In fact, FDA commissioner Margaret Hamburg said that the agency would ramp up criminal prosecution against responsible individuals who have the ability to prevent or correct violations but fail to do so.
One consequence of all of this is the increasing conservatism of internal company Medical/Legal Review (MLR) committees. This often results in endless discussion, revision after revision and other largely unproductive activities that add to cycle time, delays and sometimes completely kills important solutions and offerings proposed by the agencies that support the industry. Even putting aside all of this wasted time and effort, and the substantial out-of-pocket cost and foregone opportunities occasioned by these delays, everyone who participates in or watches this process is just plain frustrated. That's a fact that can be corroborated by asking anyone who plays in this sandbox. All of this is compounded by the poor communication from the MLR committees to agencies that seems to be the norm, which makes it that much harder for agencies to accommodate their issues and concerns.
Agencies that market themselves as creative experts and problem solvers can differentiate themselves by demonstrating to their biopharmaceutical clients that the solutions and offerings they propose are being developed with “best practices” knowledge and information on the legal and regulatory side. Instead of preparing material for the client and then just waiting for the return fire from the MLR committees, agencies that arm themselves with the right proactive advice and counsel up-front stand a much better chance of short-circuiting a lot of the rigmarole. They certainly won't short-circuit it all, and they won't always be able to persuade the client that they have thought through all of the problems and addressed them. Agencies that are proactive stand a much better chance of advancing the process, particularly if the client and its MLR committees believe the agency demonstrates credibility on legal and regulatory issues.
This is the business proposition in a nutshell. Agenices should engage experienced and knowledgeable FDA counsel to provide proactive advice on legal and regulatory issues that will help position them as market leaders in this realm. When properly presented by agencies to their biopharmaceutical clients, such up-front engagement will be perceived as adding value to, and facilitating, the overall MLR clearance process.
Arnold Friede is the principal of Arnold I. Friede & Associates