Monday, May 27, 2013

Ten Reasons Congress Needs to Give the FDA Jurisdiction Over All Compounding And They Need to Do It Now Not Later

May 27, 2013
by Sue Tuck Richmond

1.  One set of rules makes more sense than piecemeal sets of rules from both the state and federal government.

2.  Giving the FDA partial jurisdiction while leaving the states with partial jurisdiction will create much litigation in the state and federal courts and will most likely result in conflicting decisions that will take years to be decided and resolved--if ever--before another legislative fix will be needed.

3.  States will most likely not (and in some cases cannot) provide  the proper and essential funds need to enforce the rules and regulations they have regarding compounding especially if the past is any indication.

4.  State boards are made up of pharmacists--like most professions--it protects its own--even when they are bad to the bone.  The only way to get a handle on the compounding problem is to have oversight by someone other than pharmacists-who will continue to protect their own.  This is when federal jurisdiction becomes critical in any situation that is out of control.  Huge donations by compounders/pharmacist/pharmacies will be less likely to buy protection from the rules and regulations.

5.  Creating a hodgepodge of jurisdiction means that compounders will find loopholes and ways around the federal jurisdiction; whereas, if the federal government has jurisdiction or the right to exercise that jurisdiction over all compounding--the loopholes are closed.

6.   The FDA has shown that it is capable, ready and willing to get the compounding disaster under control; whereas, some states have made honest attempts to rein in bad compounders, a number of states including Texas have taken no action whatsoever since the NECC outbreak.  Texas in fact has yet to publish any disciplinary action against any of the compounders such as NECC or Franck's etc.

7.   The federal government via the FDA has the ability and resources to train, educate, oversee, maintain one mega database, and to civilly and criminally prosecute bad compounders in a consistent manner.

8.   Giving the FDA the authority to exercise jurisdiction over all compounders-both human and animal--does not mean that the states will have no jurisdiction. The states would still be responsible for licensing pharmacists, overseeing that the states rules and regulations are met and could still civilly and criminally prosecute just as is done in the WAR ON DRUGS--with states and federal government working closely together.

9.   With piecemeal jurisdiction for the FDA you still have the possibility of miscommunication and finger pointing rather than a joint effort to prevent the problems.  The state will blame the FDA.  The FDA will say it did not have jurisdiction or the proper information from the states.  Giving the FDA the authority will nix this type of issue in the future.

10.  Congress and states have tried the piecemeal litigation (although not with "manufacturing compounders" carved out) and it has simple not worked.  People and animals have died. There continues to be misinformation, misunderstandings, bad compounds, and bad compounders...jurisdiction over just the worst of the worst compounders for the FDA will not ultimately solve the problem.

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