FDA Gives New Name, Authority to One of its Advisory Committees

Posted 03 April 2015 By Alexander Gaffney, RAC

placeholder+image

The US Food and Drug Administration (FDA) has formally announced it will rename its Anti-Infective Drugs Advisory Committee (AIDAC), just weeks after announcing the committee would now oversee all HIV and AIDS drugs.

Background

News of the change was first broken by Regulatory Focuson 20 March 2015, when we reported that FDA planned to disband its longstanding Antiviral Drugs Advisory Committee (ADAC), a committee charged with the review of new HIV and AIDS drugs.

FDA said ADAC was "no longer needed," and officially terminated it on 19 March 2015.

That left one question unanswered: Which advisory committee would assume the review of new HIV and AIDS medications?

The answer, Focus learned from an FDA spokeswoman, was that FDA planned to transfer the workload and authority of ADAC to its Anti-Infective Drugs Advisory Committee.

FDA also planned to rename AIDAC, it said. The committee would be called the Antimicrobial Drugs Advisory Committee, the spokeswoman told Focus.

Committee Change Finalized

Those changes have now formally come into effect, FDA announced in a 3 April 2015 Federal Register notice.

The notice confirms the name change, as well as the Antimicrobial Drugs Advisory Committee's new charge: Reviewing and evaluating available data "concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders."

"The Agency changed the name to better reflect the products and issues that will be brought to the committee," FDA said.

AIDAC formerly had authority over HIV and AIDS drugs until that authority was transferred to the Antiviral Drugs Advisory Committee in the late 1980s.

The semantic change has at least one former high-ranking FDA official confused, however. "It is interesting that they are now going to call it 'Anti-microbial," the official told Focus. "This is more ambiguous. Whereas viruses are technically 'microbes', no one thinks of 'microbes' as being anything other than bacteria and fungi, and I doubt if many professionals ever use the term at all."

The name change became effective on 4 March 2015, FDA said in its Federal Register notice.

 

Federal Register

Share this article:

Categories: Biologics and biotechnology, Drugs, News, US, CDER

Tags: Advisory Committee, Antimicrobial Drugs Advisory Committee, Antiviral Drugs Advisory Committee

Regulatory Exchange: Latest Updates From the Community