Health products maker Johnson & Johnson disclosed that the Food And Drug Administration has rejected a computer-assisted anesthesia system it developed that coincidentally uses propofol, the powerful anesthetic blamed in singer Michael Jackson’s overdose death.
Louise Mehrotra, head of investor relations, noted the decision during a company conference call with analysts Tuesday after J&J released its first-quarter results. She told analysts J&J has appealed, asking the FDA commissioner’s office for an administrative review by an independent advisory committee.
The FDA advisory panel previously recommended approval of the system.
The FDA, criticized in recent years amid drug safety problems, has become more cautious in its decisions, frequently demanding additional data or completely new studies before it will approve new products.
J&J did not announce the decision in a press release, as it generally does.
J&J spokeswoman Kelly Leadem told The Associated Press Tuesday that the FDA during the first quarter sent the company a “Not Approvable” letter and provided information on options New Brunswick, N.J.-based J&J could consider. Those options include doing additional clinical studies. She would not disclose the other options.
J&J had heavily touted its Sedasys system as the first one using a computer to monitor both anesthesia doses and patient vital signs during low-risk diagnostic procedures such as colonoscopies. It’s meant to be used by doctor-nurse teams during such procedures – where an anesthesiologist usually is not involved, Leadem said. She said the FDA has not yet responded to the appeal request.
The product, developed by J&J’s Ethicon Endo-Surgery business, is approved in the European Union for use during colonoscopies and screenings of the upper gastrointestinal tract and also is approved in Canada for use during routine colonoscopy, Leadem said.
Date: April 20, 2010
Source: Associated Press
Filed Under: Drug Discovery