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AADA testified before Congress on compounding issues

January 30, 2017

Bruce A. Brod, MD, FAAD, Chair of the AADA's Congressional Policy Committee, today testified on office-use compounded medications and in-office preparations before the House Energy and Commerce Committee's Subcommittee on Health. Also among those testifying were Scott Gottlieb, MD, who serves as the commissioner of the Food and Drug Administration. Click here for more information on the hearing, to watch the hearing, and to read Dr. Brod's statement for the record.

 Dr. Brod at E&C on compounding issues Photo by the House Energy and Commerce Committee.

AADA sends regulatory relief recs to Medicare Red Tape Relief Project

August 25, 2017 

The American Academy of Dermatology Association (AADA) today sent a letter to the U.S. House Ways and Means Committee offering recommendations for the Committee’s Medicare Red Tape Relief Project ― an initiative that seeks to mitigate burdensome Medicare regulations. Among several recommendations, the AADA suggested the streamlining of drug prior-authorization requirements.

AADA supports bill to ensure access to compounded drugs

June 16, 2017

Congressman Morgan Griffith (R-VA) and Congressman Henry Cuellar (D-TX) have introduced legislation to address the unintended consequences of the Food and Drug Administration's (FDA) interpretation of the Drug Quality and Security Act and facilitate physician access to compounded drugs for administration in a clinical setting. The AADA has sent a letter of support for the legislation, titled the Preserving Patient Access to Compounded Medications Act (H.R. 2871).

Lawmakers push FDA to rescind guidance on compounding

May 24, 2017

Congressmen Buddy Carter (R-GA) and Chris Stewart (R-UT) spearheaded a letter to Food and Drug Administration Commissioner Scott Gottlieb urging the agency to rescind Guidance for Industry issued in December 2016 that restricts physician and patient access to compounded drugs for office-use. This letter, which was signed by 65 members of the House of Representatives, was supported by the AADA and the Drug Quality and Security Act (DQSA) Coalition.

Academy submits input to FDA on compounding

July 19, 2016
The Academy submitted input to the Food and Drug Administration (FDA) in response to its draft guidance on:

FDA releases final guidance on compounding using bulk drug substances

June 9 , 2016
The FDA released its final guidance titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The AADA asked the FDA to finalize its proposal to not take enforcement action against bulk substances, such as canatharidin, that FDA had approved for inclusion on the bulk substance list but additions had not been finalized through notice-and-comment rulemaking in the Federal Register. Read the AADA's comment letter.

In the final guidance, the FDA stated that it understood that the administrative process could be causing “unnecessary and inappropriate disruptions in patient care” and finalized its non-enforcement policy where the bulk drug substance nomination included adequate information for FDA evaluation and the substance does not appear to present significant safety risks. 

AADA testifies on in-office compounding

June 3, 2016
On Friday, June 3, Dr. Bruce Brod, chair of the Congressional Policy Committee, presented testimony at the FDA on compounding. Read Dr. Brod's testimony.