FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013 (here) .  Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues.  That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling.  It could also require a change to a REMS program or patient information sheet.

The Guidance goes on to identify when and how the Agency will notify affected application holders about the need to make safety changes to its labeling that have been identified by FDA.  It also provides applicants a chance to challenge the proposed changes.  This is particularly interesting as FDA stance, as reported in other of our blog posts here, here, and here.  ANDA applicants are not permitted to make safety label changes unless the NDA holder makes the change or the change is mandated by the FDA.  However, in this newly published Guidance, FDA gives some insight on how they may approach ANDA applicant-initiated label changes for new safety information.

FDA explains : “Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under 21 CFR 314.70 in all circumstances in which NDA holders can because an ANDA’s labeling must be the same as the NDA RLD’s labeling (with some exceptions, as described in 21 CFR 314.94(a)(8)(iv)). Accordingly, the changes-being-effected supplement process under 21 CFR 314.70(c) is not expressly available to ANDA holders except to match the RLD labeling or to respond to FDA’s specific request to submit a labeling change under this provision. ANDA holders, however, are obligated to provide FDA with information about labeling concerns, including a concern that new information should be added to a product’s labeling. See 57 FR 17950, 17961 (April 28, 1992). An ANDA holder may submit a prior approval supplement to request a change to product labeling, and “FDA will determine whether the labeling for the generic and [reference] listed drugs should be revised” (57 FR 17950, 17961). ANDA holders also have a duty to inform FDA of certain adverse events in compliance with postmarket reporting requirements, to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarket adverse drug experiences and to annually report “information…that might affect the safety, effectiveness, or labeling of the drug product” (see 21 CFR 314.80, 314.81, and 314.98).”

While this process has been in place since the finalization of the Final ANDA Rules in 1992, the practicality and the details of this process was not clearly articulated.  As such, ANDA applicants were hesitant to seek safety changes unless FDA or the innovator made a change.  This reaffirmation of the process articulated in the new Guidance may change the landscape of how plaintiff’s attorneys may now approach the two Supreme Court decisions that appeared to insulate generic applicants from failure to warn claims.  We still await the proposed regulation changes that were to address this issue as reported here . Hold onto your hats, everybody; the landscape may be changing even faster than we think!

For additional information on label changes or other regulatory issues please contact Joan Janulis at j.janulis@LachmanConsultants.com