HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Thursday, July 26, 2007

Legislation Action Alert

The newly revised  FDA Revitalization Act (also formerly known as the FDA Enhancing Drug Safety and Innovation Act or FDA Amendments Act) deserves more attention as it moves through Congress for reconciliation.  One of the readers sends in this news about a portion of the Act that should be of concern to all of us. 

He writes of his condition called Intestinal Pseudo-Obstruction and is essentially a chronic, congestive failure of the entire digestive tract.  He was one of many individuals who were taking Zelnorm, a powerful digestive prokinetic agent, manufactured by Novartis. 

On March 30, 2007, FDA banned Zelnorm after a study showed 0.11% of the individuals taking the drug were at risk for myocardial infraction, angina or stroke.  This compares quite favorable for the overall baseline risk in the overall population and even more favorably to the risks of Erythromycin (an antibiotic used to restore peristalis) which has a well-known risk of cardiac side effects and Reglan, a medication that has been available for about 40 years and causes a form of Parkinson’s Disease either temporarily or permanently in about half of the people who take it.

Though FDA promised to work with Novartis to hold a Advisory Committee Meeting to reassess the risks of Zelnorm, we are now at close to the four month mark and no advisory committee meeting has been scheduled.  It is unlikely that such meeting will be scheduled before year end 2007.

It is in this context that I noted with concern the House’s passage of the FDA Revitalization Act.  One of the provisions of the bill allows for the creation of a Drug Safety Oversight board.  Normally, most FDA advisory boards allow for patient participation in the form of a patient representative and/or outside doctor representation.  The current version of the bill does not; in addition, the bill only allows for the participation of officers from the FDA, NIH, HHS and “other appropriate federal agencies”.  Therefore, decisions made by this board will be made in a “star chamber” that omits the expertise of patients and their doctors who have the best real-life experience in dealing with the implications of the risks and benefits of various pharmaceuticals.  This provision only serves to continue the drug regulation trend where the most important participants in the process simply do not have a voice in its most important steps.

I was unaware of this provision of the Act until notified by this reader.  Please contact your congressperson if you share these concerns.

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