AANA Federal Government Affairs

Number 2010-21a -- Week of Monday, August 16, 2010

 

In This Issue:

After Five Years’ Consideration, FDA Rejects Petition to Remove Restrictive Labeling on Propofol, Agreeing with 2005 AANA Comment

 

On August 11, 2010, the Food and Drug Administration (FDA) issued a letter rejecting a citizen petition, submitted in 2005 by the American College of Gastroenterology (ACG), seeking the removal of restrictive labeling from the surgical sedation agent propofol that requires the drug be administered by persons trained in administering general anesthesia.  The AANA had submitted comment to the FDA urging that the agency reject the ACG petition; the FDA’s letter of denial expressly indicates that the agency-approved labeling for propofol will not be changed in the way that the ACG requested.

Specifically, the ACG requested that the FDA remove the following warning from the labeling for propofol:

“For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.”

ACG stated in its June 27, 2005, letter to the FDA that “substantial clinical evidence establishes that propofol can be administered safely, effectively, and cost-effectively by gastroenterologists and by registered nurses working under their supervision.” The AANA’s letter of Nov. 13, 2005, recommended against removing the FDA-mandated warnings from propofol, on the grounds of patient safety. AANA suggested that the argument of the citizen petition that the FDA ought to remove the warning from propofol on economic grounds was misplaced and unjustified based on the evidence.  Both the ACG petition and the AANA comment are available by link below.


In its petition denial letter, also available by link below, FDA said it considered ACG's claims and the literature that the gastroenterologists provided for review, but concluded that the group had not shown that the warning is no longer warranted or appropriate. The FDA’s letter states that “we conclude that the warning is warranted and appropriate in light of the significant risks associated with propofol, and we further conclude that the warning should help ensure that propofol is used safely. Accordingly, we will not seek to have the warning removed, reduced, or otherwise amended.”

FDA's letter said it disagreed with ACG's assertions that “the risk profile of propofol appears to be no worse than” alternative agents, stating, “We believe the risks associated with propofol are significantly different from — and, in some critical respects, greater than — the risks associated with the alternative sedation agents you mention.” The FDA said the risks associated with propofol are significant and may result in serious injury or death; therefore, FDA held that the current warning label is appropriate despite increased costs that may be associated with it.

Read more:

·         Read the ACG’s citizen petition to the FDA dated June 27, 2005,  http://www.regulations.gov/search/Regs/home.html#documentDetail?R=090000648043ee8e
·         Read the AANA’s letter to the FDA from November 13, 2005, http://www.regulations.gov/search/Regs/home.html#documentDetail?R=090000648043f026 
·         Read the FDA’s denial letter from August 11, 2010, http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480b32088 
·         Read the FDA’s docket on this citizen petition, http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2005-P-0059, and all publicly available comments on the issue, http://www.regulations.gov/search/Regs/home.html#searchResults?Ne=11+8+8053+8098+8074+8066+8084+1&Ntt=FDA-2005-P-0059&Ntk=All&Ntx=mode+matchall&N=0 

 

For More Information

The AANA Federal Government Affairs Hotline is published for the nurse anesthetist members of AANA the Monday following each week Congress is in session by the AANA Office of Federal Government Affairs, Washington DC, (202) 484-8400, info@aanadc.com, Frank Purcell, Senior Director.  © 2010 American Association of Nurse Anesthetists.

Frank J. Purcell
Senior Director Federal Government Affairs
American Association of Nurse Anesthetists
25 Massachusetts Ave., NW, Suite 550
Washington, DC 20001-1450
Main: 202-484-8400
Direct: 202-741-9080
Fax: 202-484-8408
Cel: 703-447-9809
Email:  fpurcell@aanadc.com
www.aana.com
Supporting Our Members—Protecting Our Patients
This email and any attached documents may contain confidential information belonging to the sender and may be legally privileged.  This email (and any attachments) is intended only for the use of the intended addressee(s).  If you are not the intended recipient(s), please notify the sender immediately and delete or otherwise destroy this transmission.