Important FDA News for GI
On June 7, 2004, the Food and Drug Administration (FDA) warned compounding pharmacies and other companies supplying domperidone that it is illegal to compound and sell domperidone in the U.S. The FDA also issued an ‘import alert’ advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. These actions were the result of the Agency’s concern regarding public health risks associated with the use of domperidone.
Although FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women, there are patients with gastrointestinal (GI) disorders, such as severe gastroparesis or severe GI motility disorders, who are refractory to standard therapy and may benefit from the drug. In these circumstances, the FDA recognizes that the drug’s benefit may outweigh its risks.
Please click here to access the IND from the FDA website.
On Monday, June 17, 2013 the U.S. Food and Drug Administration (FDA) released a statement on IND requirements for fecal microbiota for transplantation (FMT). Specifically, the FDA announced that it would use discretion in enforcing IND requirements for treatment of refractory Clostridium difficile infection (CDI) by FMT. Please click here to read the statement.
ACG members should also know that the FDA will make a public announcement prior to any decision to re-enforce IND requirements for FMT or prior to other policy changes.
The FDA is also expected to release more formal guidance on FMT in the upcoming weeks.
The College continues to work with the FDA to help streamline this process, as well as the approval process for FMT. This includes drafting recommendations to the FDA, working through the ACG FDA Related Matters Committee as well as the College’s unique “ACG-FDA Liaison Council,” a group that meets with the FDA regularly to discuss issues important to the GI clinician.
What does this FDA announcement mean?
This is a change from the FDA’s guidance earlier this year requiring providers/facilities to obtain an IND for all FMT procedures and use.
- ACG members may interpret this announcement as the FDA allowing the use of FMT for refractory CDI without having to go through the administrative hurdles of obtaining an IND (or even an emergency IND).
- However, physicians/facilities must be able to demonstrate ‘informed consent’ on all FMT procedures where an IND was not obtained; this includes at minimum a discussion regarding the risks of the procedure and full disclosure that the procedure is still considered ‘investigational.’
- While this announcement eases burdens for both research and treatment of CDI, the FDA announcement applies to refractory CDI only. FMT for other research or treatment (IBD treatment) still requires an IND.
What are the risks commonly associated with FMT?
According to ACG physician experts, the most common risks are transient cramping (1-3 days), bloating gaseousness, altered bowel habit (constipation more than diarrhea), and low grade fever for no more than 12-24 hours.
Facilities performing FMT usually include the following risks in patient/donor consent forms:
- While donor-stool is screened and tested prior to the procedures, there may be an unintended transmission of infectious organisms (bacterial, viral fungal, parasitic) as well as an allergic reaction to the donor’s stool.
- There may be enhanced colitis activity in patients with underlying IBD.
- There are complication risks associated with use of a sigmoidscope or colonoscope (facilities use separate consent form).
- FMT is not intended for or an adequate colorectal cancer screening modality.
- The donor may be responsible for certain charges not covered by insurance.
- The donor’s stool and blood will be screened and tested, and the patient will be notified if the donor is ineligible based on the results of these tests. Patients may not know the precise reason for the donor’s ineligibility but the patient will know the list of screenings and tests performed on the would-be-donor’s blood and stool.
How do I complete an IND Form?
The IND form and instructions are below.
IND Form Instructions:
The FDA also provides “emergency use” INDs in certain situations. Please call the FDA at: 301-827-2000 (or the after-hours number at: 866-300-4374).
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