As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available. That deadline—Saturday, February 11, 2017—arrives in a matter of days.
Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to publicly post their expanded access (EA) policies for individual patient access. This deadline falls on February 11, 2017. For new investigational drugs, this provision applies upon initiation of a Phase II or Phase III study for that drug.
On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student
On February 4, 2015, the Food and Drug Administration (FDA) issued a new Draft Guidance titled Individual Patient Expanded Access Applications: Form FDA 3926. The Draft Guidance introduces draft Form FDA 3926, which – when finalized – may be submitted by licensed physicians to FDA for expanded access (or “compassionate use”) requests for individual patient Investigational New Drug Applications (INDs).