One of my readers asked me to look at a recent Supreme Court ruling http://www.supremecourt.gov/opinions/10pdf/09-993.pdf which involves a case in which a generic drug manufacturer was sued in State court due to inadequate health warnings per state law. However, the drug maker met FDA requirements. The State Regulations were stronger than the Federal, however, the manufacturer was prevented from substituting the less restrictive FDA warnings because it violated FDA rules. The question was how does one meet the two standards. The Court ruled that the manufacturer had only to meet federal law (the FDA regulation). Of course, this violates the Tenth Amendment.
So where do I stand on this? I am a very strong states rights person and believe in a weak Federal system due to the fact that they get so far away from the people, that the average citizen can have no influence on any decision. States are by their very nature closer to the average Joe or Jane and therefore, we should have more chance of being heard. (Notice I said "should have" not "does".)
In this case where it deals with our drugs and the very complex nature of drugs, favoring state regulation meets the impracticality of each state having its own FDA to certify the safety of drugs. The cost of this would drive up the costs of medicine even more and that would not be practical nor efficient. If each state had to regulate drugs we could fine 50 different formulations for Viagra for example. This would be very inefficient.
I believe this comes more under the regulation of interstate commerce than states rights. The business of pharmaceuticals is very complex and would not be beneficial to have multiple jurisdictions controlling the drug formulation. However, I do believe the Supreme Court could have ruled that a state might impose stronger warnings if it so desired without violating FDA requirements. However, that was not done and from the reading I saw, was not really considered. (If someone has another source, please do advise.)
Instead, Supreme Court said that due to the fact that the FDA had rules say that all generic drugs must have similar warnings as the brand name, stronger state language cannot prevail. This does not effect the strength of the drug or its composition, rather the warnings for the person taking the medicine. I disagree with the Court and would have ruled with the minority in this case.
What do you think?
So where do I stand on this? I am a very strong states rights person and believe in a weak Federal system due to the fact that they get so far away from the people, that the average citizen can have no influence on any decision. States are by their very nature closer to the average Joe or Jane and therefore, we should have more chance of being heard. (Notice I said "should have" not "does".)
In this case where it deals with our drugs and the very complex nature of drugs, favoring state regulation meets the impracticality of each state having its own FDA to certify the safety of drugs. The cost of this would drive up the costs of medicine even more and that would not be practical nor efficient. If each state had to regulate drugs we could fine 50 different formulations for Viagra for example. This would be very inefficient.
I believe this comes more under the regulation of interstate commerce than states rights. The business of pharmaceuticals is very complex and would not be beneficial to have multiple jurisdictions controlling the drug formulation. However, I do believe the Supreme Court could have ruled that a state might impose stronger warnings if it so desired without violating FDA requirements. However, that was not done and from the reading I saw, was not really considered. (If someone has another source, please do advise.)
Instead, Supreme Court said that due to the fact that the FDA had rules say that all generic drugs must have similar warnings as the brand name, stronger state language cannot prevail. This does not effect the strength of the drug or its composition, rather the warnings for the person taking the medicine. I disagree with the Court and would have ruled with the minority in this case.
What do you think?
We agree on this one.
ReplyDeleteThe key legal issue is all the "preemption" cases (there were 5 of them in this session of the Supreme Court) is the "intent of Congress" as to whether Congress intended the federal law to preempt all state laws.
There is a long-standing precedent of the Supreme Court that the Court should make a presumption AGAINST preemption, unless Congress makes it clear that preemption is intended.
In this case, not only did Congress make no such preemption indication in the legislation itself, but the FDA actually has a requirement and a mechanism for the generic drug manufacturers to alert the FDA that a modification of the warning label is necessary.
With this decision, the Supreme Court has created a new interpretation of "impossibility preemption" that works against states rights.
Thanks for posting on this.
--David