MAPS received a call from FDA reporting that DEA’s request for a consultation about Dr. Mithoefer’s qualifications to conduct research has finally arrived at FDA. Furthermore, FDA’s recommendation has already been sent back to DEA. We are inching ever closer.
According to the Code of Federal Regulations [section 304(a) of the Act (21 U.S.C. 824(a))], DEA must issue Schedule I licenses to researchers with FDA-approved protocols within 10 days of DEA receiving a recommendation from FDA that an applicant is qualified to do the research, unless the applicant can be denied on any of the grounds specified in section 304 (a) and has either 1) lied on the application, 2) been convicted of a drug felony, or 3) no longer has State registration to administer controlled substances. Since none of these criteria apply, we may be quite close to being able to start this study.
However, there could be some delays caused by the uncertain amount of time between when FDA sends its recommendation to DEA and when DEA acknowledges receiving it, with interagency mail notoriously slow. MAPS will now work to expedite this process however we are able.