March 7, 2008
Pre-emption & the FDA: Approval of a label will it be a shield or sword?
Analysis of:
Court Allows Suit Against Drug Maker | www.nytimes.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Implications:
Does FDA approval provide a cloak for certain types of lawsuits?
Should State laws be allowed to in essence carve out exceptions to what appears to be Federal regulation?
Analysis: While this case to some may say that the Supreme Court is not yet tipping its hand to whether they will allow States to weight in on what some say is Federal regulation, a tie vote may send the message since it reaffirms the lower court. It has long been a shield & a sword to have FDA approval. On the one side some hide behind it waiving that they should not be liable for something that the government said was acceptable. Others dig deeper to potentially find evidence that even if the government waived its hand over a label a company can still have liability. The issue to really keep in mind is that in this case there was a concern that the information initially provided to the FDA was possibly some what less than accurate. Therefore, FDA approval was only as good as in essence the paper it was written upon. While at least the Bush administration has asserted their thoughts in favor of the manufacturer, it seems axiomatic that each case should lie on its own accord. Most would agree that this country fosters the rights of individuals to pursue appropriate remedies, while in the same breath ironically crying out for Tort reform!! Preemption is clearly a hot topic with ever emerging pros & cons. A former FDS Commish has spoken against preemption. http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/. 2008 may be a year for resolution on this issue.
Analysis: While this case to some may say that the Supreme Court is not yet tipping its hand to whether they will allow States to weight in on what some say is Federal regulation, a tie vote may send the message since it reaffirms the lower court. It has long been a shield & a sword to have FDA approval. On the one side some hide behind it waiving that they should not be liable for something that the government said was acceptable. Others dig deeper to potentially find evidence that even if the government waived its hand over a label a company can still have liability. The issue to really keep in mind is that in this case there was a concern that the information initially provided to the FDA was possibly some what less than accurate. Therefore, FDA approval was only as good as in essence the paper it was written upon. While at least the Bush administration has asserted their thoughts in favor of the manufacturer, it seems axiomatic that each case should lie on its own accord. Most would agree that this country fosters the rights of individuals to pursue appropriate remedies, while in the same breath ironically crying out for Tort reform!! Preemption is clearly a hot topic with ever emerging pros & cons. A former FDS Commish has spoken against preemption. http://www.pharmalot.com/2008/02/former-fda-commish-argues-against-preemption/. 2008 may be a year for resolution on this issue.
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