The First Amendment and FDA restrictions on off-label uses: the call for a new approach.
نویسندگان
چکیده
منابع مشابه
Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads.
Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug’s safety and efficacy for each intended use and has prohibited the “offlabel” promotion of drugs. For companies to market an approved medicine for new indications, they must first conduct trials and submit data to establish safety and efficacy, as ...
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s will not contain all the details of a full paper, readers recognize this limitation. A physician reading an abstract presented at a scientific conference, for example, will not be misled into believing that it is a comprehensive report of the study. Although the information in certain abstracts may not be robust enough to warrant distribution, other abstracts may describe large-scale, well-co...
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Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the ...
متن کاملOff-Label Drug Information
drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...
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I t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are released onto the market and, if it concludes that a new drug is unsafe or not effec...
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عنوان ژورنال:
- Food and drug law journal
دوره 63 2 شماره
صفحات -
تاریخ انتشار 2008