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Johnson and Johnson Files Complaint Against the FDA Regarding Sedasys Device Rejection Used for Propofol Delivery-But Wait We St

Posted Feb 17 2011 11:25pm

Propofol requires by label that an anesthesiologist be present and the device would administer the drug for surgical procedures such as colonoscopies without an anesthesiologist present.  Doctors perform colonoscopies with a mild sedative without an anesthesiologist present, but use different drugs.  Perhaps all the recent recalls is not helping here.  There is a shortage of the drug that the device would use.  Maybe Johnson and Johnson needs to manufacture the drug since we have no US manufacturers left and rely on one company in Germany to supply the entire US.  The company in the US that distributes propofol set up hot lines to help hospitals with their orders a couple months ago. 

Here’s a few more details from last year on the decision from the FDA with going from 2 US manufacturers to none within a few months. 

Teva To Stop Manufacturing Propofol – With No US Manufacturers Left FDA Approved Import From Europe

What makes this case also interesting is the division of J and looking for approval is the same division that issues recalls today. 

Maybe this is bad timing?  Right now there’s almost a no win conversation going on between safety and getting products approved sooner and that includes both drugs and medical devices, but devices are getting most of the attention right now.  In addition, some members want to cut the FDA budget and I don’t see how that can be done and get the work load handled.  The only other alternative would be to start turning down some applications and that’s not really a good answer either as companies would go elsewhere.  Some US manufacturers have already done this and are kind of writing of the US market for selling their products and going for approval in Europe and other countries.   BD

The dispute stems from the FDA's rejection last year of a medical device made by J&J, despite endorsement by a panel of expert advisers who recommended approval. In response, J&J appealed directly to the commissioner, Margaret Hamburg—only the second such appeal in agency history.

While companies like J&J complain about the FDA, the agency is also feeling heat from some members of Congress and consumer groups to be tougher. They cite recalls of devices that were found to cause serious health problems, even deaths.

The J&J device that the FDA rejected, Sedasys, is used to mildly sedate patients about to undergo routine medical tests like colonoscopies, using the drug propofol. That sedative's label requires that it be administered by an anesthesiologist.

Typically, doctors who perform these procedures without an anesthesiologist give patients a sedative other than propofol, J&J says. Sedasys could make patients more comfortable and has safeguards protecting patients so an anesthesiologist wouldn't need to be present, according to the company.

The debate boiled at a House hearing Thursday. Financial backers of medical-device start-ups criticized the unpredictability of device reviews and said it is hurting hiring, while FDA officials countered that faster reviews might result in approvals of devices that, once they are on the market, harm patients.

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