By William T. Koustas –
As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the Act”) provides a new statutory framework and authority for FDA (or “the Agency”) to require Risk Evaluation and Mitigation Strategy (“REMS”) for drugs and biologics. Specifically, FDAAA permits FDA to require the applicant of a New Drug Application, Biologics License Application, Abbreviated New Drug Application or a supplement thereof to submit a proposed REMS as part of the application prior to approval if the Agency determines that it is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.” FDC Act § 505-1(a)(1). The Agency may also require REMS after a product’s approval if FDA “becomes aware of new safety information that makes a determination that such is necessary to ensure that the benefits of the drug outweigh the risks of the drug.” Id. § 505-1(a)(2). Further, FDAAA states that drugs and biologics approved prior to the effective date of the Act are “deemed to have in effect an approved risk evaluation and mitigation strategy under section 505-1 of the [FDC Act]…if [they] are in effect on the effective date of this Act elements to assure safe use (A) required under [21 C.F.R. §§ 314.520 or 601.42]; or otherwise agreed to by the applicant and [FDA].” FDAAA § 909(b)(1). FDA listed those products in a March 27, 2008, Federal Register notice.
Since Title IX of FDAAA went into effect on March 25, 2008, FDA has required both new and previously approved drugs to develop REMS consisting of one or more elements provided for in the FDAAA provisions. Those elements include a medication guide or patient package insert, a communication plan to healthcare providers, and elements to assure safe use (e.g., a restrictive distribution program). FDC Act § 505-1(e). Additionally, all REMS must include a timetable for assessments with assessments at 18 months, 3 years and 7 years after approval of the REMS. Id. § 505-1(d).
Because the number of approved and requested REMS continues to grow and class-wide REMS begin to emerge (see FDA’s announcements regarding opioids and TNF blockers), we decided to provide a means by which to track those REMS approved by FDA – the REMS Tracker. This tracker is an Excel spreadsheet with links to letters of approval describing the REMS, a list of REMS elements required for each drug product, FDA’s stated rationale for requiring REMS, as well as other useful information. (Thanks to our legal assistant Ted Kenyon for helping us to put this together!) We will update this tracker on a regular basis as new approval letters are made available through FDA’s website. Currently, 25 drugs and biologics have approved REMS. We expect the number of REMS to grow significantly as FDA becomes more comfortable with its new power under FDAAA and as more decisions regarding class-wide REMS are finalized.