Outcome of FDA hearing about electroshock: more testing necessary

The results of the hearing are in. I’ve shared two excerpts from two reports below. Go to the sources for details:

From the Washington Post:

An expert panel advising the Food and Drug Administration decided Friday that electroconvulsive therapy (ECT) machines should undergo the same rigorous testing as new medical devices coming onto the market – a decision that could drastically affect the future of psychiatry’s most controversial treatment.

The majority of the 18-member committee said not enough is known about ECT, also known as “electroshock” or simply “shock” therapy, to allow the devices to be used without more research into its usefulness and hazards.

If the agency follows the panel’s advice, which it usually does, the two companies whose machines are used in the United States will have to provide evidence of the therapy’s safety and effectiveness either from existing research or new studies. If the FDA isn’t convinced, the devices could be removed from use.

And the New York Times:

A federal advisory panel was sharply divided on Friday about whether to recommend that regulators designate electroshock devices as high risk. The change could increase oversight on a controversial treatment used by about 100,000 Americans a year.

The Food and Drug Administration, after a two-day advisory meeting, said it would now take more than a year to decide the issue. Even then, manufacturers could be given 30 months longer to submit proof of safety and effectiveness, an F.D.A. official said.

About Monica Cassani

Author/Editor Beyond Meds: Everything Matters