 |
|
A New Era of Unapproved Drugs
The Case of Abigail Alliance v Von Eschenbach
Peter D. Jacobson, JD, MPH;
Wendy E. Parmet, JD
JAMA. 2007;297:205-208.
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
|
|
More than 100 years ago, ineffective and often dangerous medicines were widely sold. Then, in 1906, the US Congress enacted the Pure Food and Drug Act,1 prohibiting the sale of misbranded, mislabeled, or adulterated foods and drugs in interstate commerce. Over the next 60 years, Congress tightened drug industry regulation, requiring manufacturers to demonstrate to the Food and Drug Administration (FDA) that their products are both safe and effective.
In recent years, the FDA drug approval process has been heavily criticized. An Institute of Medicine report cites safety problems with approved drugs, such as rofecoxib, as evidence that FDA regulation has become too lax.2 By contrast, libertarians and some patients' rights groups have castigated the FDA for blocking access to new and, they claim, potentially lifesaving drugs.3
In May 2006, the battle took a new turn when a 3-judge panel on . . . [Full Text of this Article] The Case
Author Affilations: Center for Law, Ethics, and Health, University of Michigan School of Public Health, Ann Arbor (Mr Jacobson); and Northeastern University School of Law, Boston, Mass (Ms Parmet).
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
Reviews in Medical Ethics.
Daar
J Law Med Ethics 2008;36:184-190.
Litigating the Science of Breast Cancer Treatment
Jacobson et al.
Journal of Health Politics, Policy and Law 2007;32:785-818.
ABSTRACT
Cancer and the Constitution -- Choice at Life's End
Annas
NEJM 2007;357:408-413.
FULL TEXT
|
