The U.S. Food and Drug Administration (FDA) has initiated a transparency effort by publishing over 200 complete response letters (CRLs) that it sends to drug companies when rejecting medicine applications. This marks the first time the agency has made these rejection letters publicly accessible in a centralized manner. The letters primarily pertain to drugs that were eventually approved, including many generic drugs. At least 14 of these letters were published for the first time, revealing new details on efficacy concerns in some cases, such as a 2019 letter to AstraZeneca. The FDA commissioner, Dr. Marty Makary, described this move as delivering on a promise of "radical transparency" to provide developers, investors, and patients with clearer insights into the agency's decision-making process. Previously, some CRLs were disclosed in approval packages but were scattered and difficult to access. The agency acknowledged that some drug companies preferred these letters to remain confidential, but emphasized the need for transparency to prevent companies from spinning information to investors and shareholders. This initiative is seen as a step toward greater openness in FDA drug approval decisions, although it currently excludes letters for drugs that were never approved.
Two easy ways for the FDA to improve transparency by @Frank_S_David https://t.co/nM0A3VVM8o
.@Frank_S_David in @statnews: How the @US_FDA can score quick wins on transparency (Yes please!) 1) integrate all public info & docs about approved drugs into the Drugs@FDA database, upgrade interface for advanced searches, downloads, and analyses 2) publish machine-readable
My suggestion for @DrMakaryFDA on boosting "radical transparency" at the FDA: https://t.co/j8MVYe5cA8