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# SSS REMS Comments
- URL: https://www.fdaweb.com/sss-rems-comments/
- Published: 2020-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:15:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146817

The Association for Accessible Medicines (AAM) says FDA should implement the REMS (Risk Evaluation and Management Strategy) requirements for drugs approved under ANDAs. Commenting on an agency draft guidance on the development of a shared system risk evaluation and mitigation strategy, AAM [says](https://www.regulations.gov/document?D=FDA-2018-D-1041-0023&ref=fdaweb.com) that as a result of recent changes in the laws covering single shared system (SSS) REMS, the association and its members believe that to accomplish the goal to close loopholes that allow brand companies to use REMS to block or delay generic competition, fundamental changes are needed in the processes for handling REMS with elements to assure safe use (ETASU) and the relevant guidances that describe the processes.

“FDA needs to address the entire lifecycle of the REMS process from the initial development of a REMS with ETASU through modifications to REMS by the brand companies, and the development of REMS by ANDA applicants to prevent REMS with ETASU from having anticompetitive effects,” AAM says. “FDA must look at the current situation with regard to pending REMS and waiver requests and devise a path forward that will eliminate obstacles to expeditious approval of ANDAs required to have REMS.”

In its [response](https://www.regulations.gov/document?D=FDA-2018-D-1041-0022&ref=fdaweb.com), Teva acknowledges that FDA has made significant efforts in the past year to mitigate the problem of unnecessary delays encountered by many ANDAs related to SSS REMS. The company says that while it has seen positive results from the agency efforts, there remain many sticking points that FDA could help to address.

AstraZeneca submitted a [comment](https://www.regulations.gov/document?D=FDA-2018-D-1041-0021&ref=fdaweb.com) with one specific technical issue.