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¶ … FDA has an early approvals process. They use it for treatments that address an unmet need. They used this twenty years ago to get AZT through in 10 months. They used it as well this past year for a new drug to address a particular type of non-Hodgkin's lymphoma. The H1N1 appears to fall into the same category for the FDA. It is a new strain, for which there was no treatment or vaccine. H1N1 is highly visible, so dealing with it becomes a political issue as well, especially with the flu season coming. I would suspect, however, that future treatments for H1N1 have to go through a longer approvals process.
I would expect that legislation is coming, at least in the form of FDA regulations. Genomic testing falls into a dangerous sub-category of biotech work that is devoid of regulations and is of uncertain value to the consumer. It is interesting that 23 andMe would put a bill to Congress to exempt themselves from scrutiny. That sounds like a calculated gamble. They may be better off in the long run working with regulators so that they have a say in how their industry will be regulated, rather than trying to avoid regulation. This situation illustrates the difficulties in navigating an uncertain regulatory environment.
3. It is reasonable that the WHO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded to the need to encourage innovation. The balance between innovation and cost control is different in the U.S. than in Europe, so I think that is why U.S. policy will look slightly different than European policy. It will be interesting to see how that plays out. In Europe, there has obviously not been much innovation in this field in the past few years, if new product introductions are any indicator. If the U.S. system can stimulate more innovation, that can actually be used to demonstrate the power of the American model and perhaps drive changes in Europe, rather than the other way around.
Works Cited:
Riley, K. (2009). FDA approves first drug for treatment of peripheral T-cell lymphoma. FDA. Retrieved November 19, 2009 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183799.htm
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND
FDA Drug Approval Process In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $500 million, and it takes an average of fifteen years for a drug to make it from initial testing to being available for patients. Furthermore, of every 5000 compounds
Thalidomide Although the United States succeeded in averting the same thalidomide tragedy that occurred in Europe by refusing to approve the drug, some observers counter that the action introduced unnecessary delays in the approval of many useful drugs. Given that thalidomide is now accepted as an effective treatment for leprosy, this paper provides an evaluation concerning whether Dr. Frances Kelsey was correct in stopping the development of thalidomide in the
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Fluoxetine (Prozac) Since its approval for use in the United States by the FDA in 1987, fluoxetine (commonly known as Prozac) has been the subject of great debate. Fluoxetine, now available in generic form, has been proven useful in the treatment of depression, anxiety, obsessive-compulsive disorder, some eating disorders, panic disorder, insomnia, migraines, schizophrenia, and more (Schmetzer, 2002). However, this drug does have a range of possible side effects including sexual
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