The FDA is asking for comment to determine whether it should reclassify ECT to require "reasonable assurance of the safety and effectiveness" of the mechanical devices used for electroconvulsive therapy. ECT was already in use when the FDA codified mechanical devices, and hence grandfathered under a classification that today would require testing for safety and efficacy. In response to public interest and complaints, the FDA is deciding whether a "premarket approval" is necessary in the "completion of product development." The answer to this will influence whether they downgrade the classification under less stringent rules. Some consider this tantamount to deregulation.
For many years ECT was the symbol of abuse and indiscriminate use. More recently it has been used as a treatment of last resort when others have failed. In a review of Shock, a book about ECT, Dr. Sigurd Ackerman wrote:
At various times in its nearly 70-year history ECT was viewed as a medical miracle and as a barbaric torture; as an instrument for giving the mentally ill their freedom and as an instrument for taking it from them; as a precise, scientific tool and as a very unscientific shot in the dark; an example of the enlightenment of modern psychiatry and an example of its ignorance; a treatment that makes patients well and an assault that makes them worse.
Comments have been submitted by disability rights advocates, family and consumer advocates, current and former patients, and medical professionals. Many contain personal testimonies based on experience and recommendations about reclassification based on evidence about danger (including side effects), efficacy and consumer choice. As of today, 229 public comments can be seen on the FDA's submission page, http://www.regulations.gov. (Under keyword enter ECT, and click comment
Read more about the current controversy:
Mindfreedom
To comment before Jan. 8, 2010:
Electronic submission: http://www.regulations.gov.
Written comments:
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Victor Krauthamer, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., W066-1106, Silver Spring, MD 20993, 301-796-2474.
