The FDA’s drug safety director, Gerald Dal Pan, has given an update on progress to date, including a tally of 34 new postmarket studies or clinical trials ordered last year.
Addressing a Food & Drug Law Institute conference in January, Dal Pan called 2008 a particularly “eventful year,” with important organizational and management changes and over 100 approvals of drug and biologic applications and efficacy supplements during the period from March through November.
Twenty-four of the post-market safety studies or trials ordered were associated with initial NDA or BLA approvals, and the remaining 10 were for already-approved products, based on “new safety information,” or newly-identified “serious risks.”
Dal Pan indicated that changes were required for seven safety labels, including changes applicable to some drug classes, and a total of 21 risk evaluation and mitigation strategies (REMS) were approved. The latter included 16 actions in which the strategies consisted of Medication Guides (MedGuides) only, and five actions in which the required REMS included other elements to assure safe use of a product and/or a communication plan for educating health care providers and patients in safe use of a product.
A more detailed discussion of REMS—including the FDA’s interpretation of relevant statutory provisions and authorities, and early steps toward implementation—was provided by Dal Pan’s acting director of the Division of Risk Management Claudia Karwoski.
She noted that REMS are tailored to address safety issues associated with specific, individual products, and thus they may take many different forms. “The only common element required of all REMS is a timetable for assessing their effectiveness,” she said.
In some cases, sponsors may believe that adherence to practices specified in a MedGuide are sufficient to constitute a REMS; but in all such cases, when applying to the agency, sponsors should include a description of how MedGuides will be distributed, Kawolski said. In cases where FDA requires REMS to include a communication plan, the target audiences must be described, and any educational materials appended to the REMS proposal.
According to Karwoski, examples of some elements of REMS that may be considered by sponsors to assure safe use would include: requiring healthcare providers and pharmacists to have special training or experience or special certifications; requiring that the drug be dispensed only in certain healthcare settings; and requiring that each patient taking the drug be enrolled in a registry, or subject to blood tests or other periodic monitoring.
From the March 01, 2009 Issue of MM+M - Medical Marketing and Media