FDA Proposes Timetable for Review of Modified Risk Tobacco Products

By Ricardo Carvajal –

FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).  FDCA section 911(a) prohibits the introduction of an MRTP into interstate commerce unless FDA has issued an approval order under section 911(g).  However, the statute does not specify a time limit for FDA’s review and decision on MRTP applications.  Instead, the statute allows FDA two years to issue a regulation or guidance that establishes a “reasonable timeframe” for its review.  The lack of a time limit for review was a key issue cited in a recent case challenging the constitutionality of the MRTP provisions (see our prior post).  Although plaintiffs in that case failed to secure a preliminary injunction, the court noted that the lack of a reasonable time limit for review of MRTP applications rendered the statute potentially vulnerable to a First Amendment challenge (“The Court thinks it likely that this two-year delay is unconstitutional given that certain portions of the MRTP provision have been in effect since June 22, 2009”).

FDA’s draft guidance appears to address that vulnerability by establishing a “reasonable preliminary timetable” of 360 days.  In doing so, FDA dismissed the 180-day time period for review of drug and device applications as too short, given the statutory requirements that FDA seek public comment on MRTP applications and also refer them to the Tobacco Products Scientific Advisory Committee.  FDA also tentatively dismissed the 540-day time period for review of health claims as unnecessarily long, given that notice-and-comment rulemaking is not required for a decision on an MRTP application.  The draft guidance signals that the agency expects to issue more detailed guidance or regulations once it has acquired a base of experience with processing MRTP applications.  In the interim, the guidance suggests that the first MRTP applicants may be in for a rough ride:

The Agency has not yet received an MRTP application. It therefore does not have experience in reviewing such applications, and has no information based on prior experience regarding the length of time required for review of such applications. Moreover, the MRTP application review process and approval criteria are new, and the Agency is likely to encounter a number of questions of first impression involving science, law, policy, and procedure. Resolving questions of first impression may mean that the initial applications will require more time than later submitted ones.

Comments on the draft guidance are due by February 25, 2010.