Eric D. Shah1, Dawn B. Beaulieu2, Bruce Yacyshyn3, and the ACG FDA Related Matters Committee4
Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA1
Division of Gastroenterology, Vanderbilt University Medical Center, Nashville, TN2
Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH3
American College of Gastroenterology, Bethesda, MD4

Grant support: None

Manuscript word count: 798

Disclosures: The authors have no relevant disclosures.

Author contributions: Eric Shah authored the initial draft of the manuscript. All authors were involved in study concept, critically revised the manuscript and approved the final copy.

Corresponding Author:
Eric D. Shah, MD, MBA
Assistant Professor of Medicine
Director, Center for Gastrointestinal Motility, Esophageal, and Swallowing Disorders
Division of Gastroenterology and Hepatology
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03766
Phone: (603) 650-5261
Fax: (603) 727-7925

"Well-placed information can assist a busy physician in locating new drug safety information at the point of care."(1)
Dr. Norman Marks, FDA
Dr. Karen Weiss, FDA

The inner workings of the Food and Drug Administration (FDA) can seem elusive from the realities of the day-to-day clinical practice.  For the FDA to accomplish its mission, they have exclusive access to comprehensive and historical clinical trial data and a wealth of outcomes data. These data include the largest claims dataset covering over 227 million Americans, including patient-level data (2). Staying up-to-date with FDA communications is important as gastroenterologists and their patients look for guidance in areas of rapid innovation such as biosimilars(3), fecal microbiota for transplantation(4), and endoscopic bariatric treatments.

Below is a summary of useful datasets and resources published on the FDA website which can enable gastroenterologists to stay current with regulatory guidance and access valuable FDA resources.

Drugs@FDA is the primary database housing copies of the most up-to-date labels for FDA-approved drugs in a PDF format. The label is a standardized document which summarizes important information on intended use, safety, and efficacy. The first page of the label summarizes major recent changes to the label, indications for use, dosing, contraindications, warnings and precautions, and adverse reactions. Detailed information is contained on following pages, and the section headings on the label remain the same regardless of the drug. Drugs@FDA can be easily searched by typing either generic or brand names of medications. The database also contains a link to the Medication Guide for each drug, which explains serious side effects and treatment considerations using more accessible, non-medical language which can be appropriate as a patient handout.

Rare clinical implications are not always evident from clinical trial data. When a clinical scenario is unexplained or serious, and especially with evidence of exposure to a drug or device, a report can be made to the FDA using MedWatch(5). MedWatch is the FDA’s adverse event reporting system for drugs, biologics, supplements, and devices and is voluntary for patients and gastroenterologists, but required by industry. All reports are reviewed by dedicated teams at the FDA to assess accuracy and completeness of the report and to assess patient follow-up.

The FDA publishes databases of adverse event reports for drugs (FDA Adverse Event Reporting System [FAERS]) and devices (Manufacturer and User Facility Device Experience [MAUDE]). Reports contained within these databases are derived from MedWatch as well as case reports published in the literature and are regularly reviewed by dedicated teams at the FDA. In practice, this may be useful to help assess: Has a particular event happened to other patients exposed to a drug or device? What led up to the event? What was the outcome? There are at least two important considerations to the interpretation of these datasets. First, reports cannot be used to indicate causation. Second, these datasets cannot provide estimates of incidence or risk, due to the voluntary nature of patient/provider reporting and the potential for duplicate reports.


The FDA regularly monitors adverse event reports to identify potential safety concerns in practice(6). When a potential safety concern is identified by FDA epidemiologists, multidisciplinary teams of physicians, epidemiologists, biochemists, pharmacologists, engineers, and other professionals work together to understand the problem. These findings are often communicated to the public in the form of a safety communication, which details newly discovered adverse events associated with a drug or device, potential risk factors, impact on labeling, and mitigation strategies when an event occurs.

If the FDA determines that a safety communication alone would be insufficient to protect patients from particular risks associated with effective treatments, it can mandate that a formal Risk Evaluation and Mitigation Strategy (REMS) be implemented(6). In these cases, it is important to be familiar with FDA requirements for medication prescribing, particularly on how to obtain required training on associated risks, how to provide specific patient education on risks, and how to conduct ongoing monitoring in practice when the medication is prescribed.

As more clinical data and experience are gained with technologies such as biosimilars, fecal microbiota for transplantation, or bariatric devices, the FDA occasionally provides guidance documents which outline regulatory considerations relevant to gastroenterologists with clinical interests in emerging areas of practice. Draft guidances are published in advance of final versions and are open to public comment during the development period.

The FDA works hard to ensure that patients and their gastroenterologists can trust the drugs and medical devices they use to manage disease. We outlined several publicly available FDA resources which collate important clinical and regulatory information for gastroenterologists and their patients in day-to-day clinical practice.

Table: Useful resources for clinical gastroenterologists available on the FDA website

Resource What it offers Link
Drugs@FDA Provides access to the most recent labels, technical reviews, and medication guides for FDA-approved drugs
MedWatch Online system for voluntary patient or provider reporting of serious adverse events or product use errors using FDA Form 3500 (Voluntary Adverse Event Report)
FDA Adverse Event Reporting System (FAERS) Database of adverse event reports and outcomes associated with drugs
Manufacturer and User Facility Device Experience (MAUDE) Database of adverse event reports and product use errors, and outcomes, associated with devices
FDA Guidance listings Provides the FDA perspective on drug and device development and regulation for specific clinical subject areas

Drug safety communication listings Updates on safety concerns, changes in labeling, and mitigation strategies important for clinical practice. These listings can be searched by drug name.
Device safety communication listings Updates on safety concerns, changes in labeling, and mitigation strategies important for clinical practice.
Medication guide listings Listing of FDA-approved medication guides which outline concerns with particular drugs as patient education documents. The database is searchable by drug name.
REMS@FDA Listing of drugs requiring Risk Evaluation and Mitigation Strategies (REMS). The database is searchable by drug name.



1.         Marks NS, Weiss K. Boxed warnings and other FDA communication tools. Am. Fam. Physician 2010;81:259.
2.         Sentinel System. United States Food and Drug Administration.
3.         Center for Drug Evaluation and Research. Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry. United States Food and Drug Admiinstration. Dec 2018.
4.         Center for Biologics Evaluation and Research. Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridiumdifficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry. United States Food and Drug Administration. Mar 2016.
5.         Craigle V. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. J. Med. Libr. Assoc. 2007;95:224–225.
6.         Gassman AL, Nguyen CP, Joffe HV. FDA Regulation of Prescription Drugs. N. Engl. J. Med. 2017;376:674–682.