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Topic: Regulatory Affairs
April 3, 2014 | Posted By Bruce D. White, DO, JD

A March 24, 2014, article in the New York Times about the dangers of liquid nicotine used in e-cigarettes and the lack of Food and Drug Administration (FDA) involvement in its regulation emphasized a decades old problem.

Before 2009, Congress prohibited the FDA from regulating tobacco products as customarily marketed. When the Food, Drug, and Cosmetic Act (FDCA) was enacted in 1938, Congress specifically defined drugso as to exclude tobacco products. In effect, Congress reserved the regulation of tobacco products to itself. More than likely, Congress – understanding the economic impact of tobacco at the time – preferred to retain a direct hand. This singular control by Congress was reiterated by the US Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (1990) when the FDA asserted itself and attempted to prohibit the sale of tobacco products to minors by regulation. In Brown & Williamson, the Court struck the regulation down.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

September 5, 2013 | Posted By Bruce D. White, DO, JD

At a conference a few days ago I sat beside a former deputy commissioner of the Food and Drug Administration (FDA). We were in a small group that was discussing the need to help interested parties in Brazil, China, and India learn more about US drug regulatory affairs and compendial science. As best I could understand, the food and drug regulatory infrastructure in China and India appears to be much the same as it was in the US around the 1930s and 1940s. However, everyone agreed that China and India have some of the best medicinal chemists, pharmaceutical formulations engineers, and pharmacy plant manufacturing and pharmacokinetics specialists in the world.

During the conversation I learned that the vast majority of the world’s commercially available antibiotic products are manufactured in China and India. This information struck me as a shock! Until then, I had been under the impression that when the last antibiotic manufacturing plant closed in the US in 2004 and the industry moved off-shore, that the companies had gone to Puerto Rico and Europe. But China and India?

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 1, 2013 | Posted By Bruce D. White, DO, JD

Recently, The New York Times in a series of reports has alerted the world to many of the ethical difficulties in marketing drugs globally. The titles of the articles alone hint at many of the issues: “Drug Research in China Falls Under a Cloud; “Glaxo Says Executives May Have Broken Chinese Law; “For Global Drug Manufacturers, China Becomes a Perilous Market.

Moreover, phrases used contextually in the articles are even more alarming: “Glaxo’s problems may go beyond the sales practices that are currently at the center of a bribery and corruption scandal”; “the company fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data”; “[research] supervisors did not always ensure that the work done there was of high quality”; “auditors came across six [animal] studies whose results had not been reported, even though early trials in humans were already underway”; “auditors found that Glaxo employees failed to record whether the [human subject] research participants had signed new consent forms”; “Glaxo said that employees were properly monitored trials but that they were not adequately documenting their work”; “[Glaxo] used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales.”

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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