FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT

By Rachel Sachs

Yesterday, the FDA announced a new draft guidance regarding its exercise of its enforcement discretion around the investigational new drug (IND) requirements as they apply to fecal microbiota transplantation, or FMT.  For almost three years now, the FDA has exercised its enforcement discretion for FMT under a rather permissive set of guidelines, enabling patients to access FMT while companies shepherd a set of products through the clinical trial process.  I recently co-authored an article about the FDA’s regulation of FMT, and I’m concerned about this new guidance, in terms of safety, access, and regulatory clarity.  This is one of the wonkiest posts I’ve written in some time (and that’s saying something), so I’ll endeavor to be as clear as possible.

What is FMT and why is it important? To make a long story short, it’s a poop transplant.  Filtered stool from a healthy donor is transplanted into the gastrointestinal tract of a sick patient.  Although scientists are continuing to explore the use of FMT for a range of indications, we already know that FMT is a startlingly effective treatment for recurrent C. difficile infection.  C. difficile infections have become among the most common hospital-acquired infections in the United States, with more than 450,000 total incident infections annually.  Unfortunately, many of these infections are resistant to antibiotics: with those 450,000 infections came 80,000 recurrences and 29,000 deaths.  But FMT may provide a way forward.  A recent randomized trial of patients with recurrent C. difficile infections was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those getting only antibiotics.

How is the FDA involved? In May 2013, the FDA announced that fecal microbiota would be regulated as a drug.  All uses of FMT would therefore need to be part of an IND application, and patients who wanted to be treated with FMT for recurrent C. difficile would need to participate in a clinical trial to do so.  Physicians and scientists responded with concern, arguing that available evidence supporting FMT’s effectiveness as a therapy for recurrent C. difficile infection was too compelling for regulators to restrict its availability to clinical trials.  As such, in July 2013, the FDA announced that it would exercise enforcement discretion when FMT was used to treat patients “with C. difficile infection not responding to standard therapies,” so long as the treating physician obtained informed consent. Continue reading

Short-Term Emergency Commitment Laws and their Impact on Firearm Possession Rights

By Andrew T. Campbell, Esq.

The Policy Surveillance Program recently updated its dataset analyzing state laws governing the short-term emergency commitment process. This dataset includes state laws that limit an individual’s right to possess a firearm following short-term emergency commitment. This aspect of the law captured by the dataset is particularly relevant given the unfortunate rise in mass shootings throughout the United States in recent years, with the latest shooting occurring in Kalamazoo, Michigan on February 21 (see also Deadliest U.S. mass shootings – 1984-2015 from the Los Angeles Times). These mass shooting tragedies have spurred debate and legislative action on gun control, to which issues of mental health have become inextricably intertwined despite research that indicates that mental illness is only a small factor in violence (see for example Mental health legislation complicated by gun control debate from The Washington Post; and Debate over gun control, mental health starts anew from CBS News). Additionally, on January 5, 2016, President Obama announced an executive action to battle gun violence, which includes a $500 million investment toward increasing access to mental health care.

With respect to the legal landscape, federal law restricts the sale of firearms to individuals who have been adjudicated as a “mental defective” or “committed to any mental institution.” Committed to a mental institution in this instance encompasses long-term involuntary commitments, but does not include those admitted for observation, i.e., short-term emergency commitment. Some states, however, have gone further and have enacted more extensive legislation that limits the right to possess a firearm for individuals who have been subject to short-term emergency commitment. With short-term emergency commitment, law enforcement officers and certain other individuals have the right to involuntarily admit individuals to a mental health care facility for a short period of time if they are displaying symptoms of a mental illness and pose a danger to themselves or others. Continue reading