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Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu
Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu
William & Mary Business Law Review
Pharmaceutical manufacturers develop relationships with healthcare providers for several purposes, including the marketing and sale of their products. Professional associations give guidance to physicians and companies for managing these relationships ethically. Some practices permitted by these associations entail conflicts of interest. This Article explores two of these practices: (i) company funding of external educational seminars, conferences, and continuing medical education; and (ii) company-hosted speaker programs. The conflict of interest concerns raised by the former practice are manageable, and the practice should continue to be permitted subject to appropriate safeguards; however, the conflict of interest concerns raised by the latter practice …
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Saint Louis University Journal of Health Law & Policy
Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …