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Full-Text Articles in Law
Why We Need Global Standards For Corporate Disclosure, Allen L. White
Why We Need Global Standards For Corporate Disclosure, Allen L. White
Law and Contemporary Problems
After two years of gradual revelations concerning undisclosed information on suicidal risks to children on antidepressants, a federal advisory committee in Sep 2004 recommended that such drugs be labeled to alert physicians and consumers of this risk. The antidepressant story is noteworthy in its own right, shedding light on the tangled web of legal, regulatory, economic, and ethical issues surrounding disclosure practices in the pharmaceutical industry. The complex interworkings of an emerging global economy make it necessary for corporate standards for disclosure to be established and enforced.
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Law and Contemporary Problems
Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA's pharmaceutical data and the resultant restrictions on open discourse. A review of open-government procedures and litigation at the FDA demonstrates that the need for transparency at the agency extend well beyond the reach of any clinical trial registry.
The People’S Agent: Executive Branch Secrecy And Accountability In An Age Of Terrorism, Sidney A. Shapiro, Rena I. Steinzor
The People’S Agent: Executive Branch Secrecy And Accountability In An Age Of Terrorism, Sidney A. Shapiro, Rena I. Steinzor
Law and Contemporary Problems
Shapiro and Steinzor apply the agency theory to the question of how much secrecy is too much. They use the theory to evaluate the impact of burgeoning secrecy in the likelihood that the executive branch officials will engage in faithful and forceful implementation of statutory materials, particularly in the arenas of protecting public health, safety, and natural resources.
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Law and Contemporary Problems
Lassman examines the tension between transparency and other public health interests in the context of the FDA's proposed Drug Watch web site. He argues that although the FDA proposal seeks to achieve a laudable goal--the prompt communication of important useful safety information about drug products to physicians and patients-- it fails to properly balance transparency and other legitimate public health interests.
Open Secrets: The Widespread Availability Of Information About The Health And Environmental Effects Of Chemicals, James W. Conrad Jr.
Open Secrets: The Widespread Availability Of Information About The Health And Environmental Effects Of Chemicals, James W. Conrad Jr.
Law and Contemporary Problems
Conrad discusses the point of view of the chemical industry concerning when and how access to health effects information may be affected by financial interests. He argues that no qualitative distinction can be drawn between the financial and other incentives that might affect disclosure by for-profit entities and the incentives that might affect disclosure by other entities that may conduct, sponsor, or opine on scientific research.