In its recent letter to Congress, the IACP states,
[it] has seen no evidence that the FDA has been unable to obtain access to the records they seek under the existing process,” according to the letter. “The Agency has provided no data on the number of pharmacies it has inspected, the number of pharmacies which did or did not claim the exemption, the number of court orders, warrants, or subpoenas that were requested to obtain those records after an exemption was claimed, or whether any of those court requests were declinedThese statements by the IACP are unfair for several reasons and misleading to those who don't understand federal court procedures and laws. First, to be able to obtain a court order, warrant or subpoena from a federal district court is no easy task. I have practiced in both state and federal court. A federal court requires a whole lot more in most states than a state court does to obtain an order, warrant or subpoena. The FDA cannot on its own get the order, warrant or subpoena it must go through the United States Attorney's office in the district where it wishes to obtain the court order, warrant or subpoena. It is beyond the scope of this blog post to discuss which district would have jurisdiction over what pharmacy and what information, etc. That is an entirely different issue. It is also an entirely different issue as to whether you are seeking a federal civil or criminal order, warrant or subpoena. Different standards apply for obtaining civil versus criminal orders, warrants and subpoenas. Also note that in additional to the Federal Rules of Criminal Procedure and the Federal Rules of Civil Procedure that must be complied with each individual district court has its own rules that must be complied with--these are the procedural aspects that must be complied with. Then there is the matter of the substantive law that must be complied with or meet. In most cases, you most have a sworn statement from a federal agent backing up your facts and you must appear before a federal magistrate in some cases. It is far beyond the scope of this blog entry for me to give a complete less on what is required and how detailed it is but it is not something you run out and get...it can take days and even weeks. There are ways to get emergency orders, warrants and subpoenas but that is another matter.
Second, underlying the entire discussion above is the assumption and it is a big one here--that the FDA has jurisdiction over the matter. Hum? Does it? Isn't that a gray area? Isn't that something people disagree on? No clear cut authority exist right? If you have never been in the hot seat before a federal district magistrate or a federal district judge answering questions, there is one thing you should know. The one thing you should know is you had better be up front with that judge who is relying on you to tell him what the law is. Well, your Honor....it is not clear the FDA has jurisdiction to inspect this pharmacy but we want you to sign this order, warrant or subpoena, etc.
There are probably several reasons the FDA hasn't provide any data on this. My guess is very few, if any, United States Attorney's Office are going to take this type of request to a federal court in light of the circumstances. Again it is very easy to be critical when one does not understand the process of the hoops that must be jumped through when clear authority does not exit, and even when it does.
As a side note after the ones being inspected or investigated have been tipped off, there is always the potential that evidence will be destroyed. If the FDA clearly had authority to inspect and investigate then a court order, warrant or subpoena could be obtained and served at the same time the FDA first knocks on the door of the pharmacy. Without that clearly defined authority there is a huge risk that evidence and information will potential be destroyed.
And on another note if a federal magistrate refuses or declines to issue the order, sign the warrant or subpoena then it can be appealed to the district court. This is another topic requiring its own explanation. Government appeals are unlike any other. There is a process requiring approval from the Department of Justice before an appeal may be initiated. This takes time. The actual appeal takes time. The time it takes versus the benefit gain is always a factor to be considered If the district court judge denies the request that decision with Department of Justice approval can be appealed to the Circuit Court. Again this takes take and follows a court imposed schedule. The next stop is the Supreme Court. The United States Supreme Court does not have to hear the case if it chooses not to do so. The bottom line is there is a very long and detailed process that must be followed with lots of careful planning and thought process each step along the way. It is not as easy as just saying why didn't the FDA just go get a court order, subpoena or warrant.