Regulatory Roundup: FDA Released Draft Guidance for Industry on Safety Labeling Changes

Published on: 

FDA Released Draft Guidance for Industry on Safety Labeling Changes.

FDA released a draft guidance for industry on Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, on April 12. The draft guidance aims to put into practice requirements and enforcement tools called for by the 2007 FDA Amendments Act (FDAAA). Specifically, the Act authorizes FDA to require (or in some cases, order) certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after approval of the product.  The document applies to prescription drugs approved via NDA or ANDA and biological drugs approved via BLA.

Past practice involved the agency asking drug sponsors of approved products to make labeling changes related to safety after approval to address serious risks. The change was usually submitted in a supplement by the drug sponsor to FDA. The agency had little authority to enforce the changes, however, and negotiations between the drug sponsor and the agency were often needed, according to the draft guidance document.  Now, under FDAAA, the agency can take action against a drug sponsor if requested labeling changes are not made. Enforcement actions include initiating proceedings to withdraw approval of the drug and notifying the public about safety information. The draft guidance details the definition of “new safety information,” timeframes, and other components of such a labeling change. Comments are due by July 12, 2011.

FDA Commissioner Margaret Hamburg will testify before the US House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, on "Import Safety: Status of FDA's Screening Efforts at the Border" and Predictive Risk-based Evaluation for Dynamic import Compliance Targeting, on April 13.


FDA Center for Devices and Radiological Health Director Jeffrey Shuren is scheduled to testify before the US House Committee on Oversight & Government Reform, Subcommittee on Health Care, on the "Pathway to FDA Medical Device Approval: Is There a Better Way?" on April 14.