Thomas W. Baker | Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
The pharmaceutical and medical device industries depend on relationships with physicians for both conducting clinical trials required for Food and Drug Administration (“FDA”) approval and prescribing or ordering pharmaceuticals and medical devices once they are approved. From these arrangements, however, substantial regulatory risk arises.
What Laws Generally Govern Relationships with Physicians? Arrangements that involve physician referrals and judgment are generally governed by two laws: the Ethics in Patient Referral Act (the “Stark Law”) and the federal Anti-Kickback Statute. While other laws may be implicated, these two laws, when complemented by the federal False Claims Act, continue to define permissible and impermissible conduct.
In The Headlines
Mike Rozembajgier | Stericycle
Enforcement of environmental regulations in the pharmaceutical and retail pharmacy industries is on the rise, and there is a growing awareness of hazardous waste non-compliance. Fines levied against major retail brands, including many household names, have exposed the public and the retail industry to the fact that retailers are liable under the law as handlers of hazardous waste.
Among the items that may be considered pharmaceutical hazardous waste are expired prescription drugs, waste materials containing excess product, and any unused drugs (including OTC) intended for discard. Under existing hazardous waste regulations, many pharmaceutical manufacturers and their suppliers are considered large quantity generators of hazardous waste.
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Topic of Discussion
Keith M. Korenchuk, Marcus A. Asner, Samuel M. Witten and Jocelyn Wiesner | Arnold & Porter LLP
Growing the bottom line by basing growth plans in the developing economies of the world has become almost an accepted truism in the pharmaceutical industry. Focusing future profitability on the “BRICs” (Brazil, Russia, India, China) is part of that push to sustained growth for many executives. For those responsible for compliance, however, these plans present substantial challenges. How those compliance challenges are met, will in large part determine whether the business goals are met. This articles addresses how to respond to those risks, focusing in this case on Russia.
Continue reading "Doing Business in Russia: Managing Anti-Corruption Risks"