September 24, 2018
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
c/o Division of Dockets Management
Food and Drug Administration
Room 1061, HFA-305
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. FDA-2018-N-2544: "Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments."
Dear Dr. Gottlieb,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to comment on the Food and Drug Administration's (FDA's) draft guidance "Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments" (Docket No. FDA-2018-N-2544) (the "Draft Guidance") published in the July 25, 2018 issue of the Federal Register. Representing over 104,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs),2 and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States, many of whom provide professional services such as medical nutrition therapy (MNT)3 and the ordering and provision of therapeutic diets and medical foods to manage and treat a wide variety of disease states and chronic conditions.
The Academy generally supports the FDA's Draft Guidance, noting that it provides important provisions for the standardization of medication preparation and delivery using foods and fluids.
A. Support for Specific Provisions
The Academy appreciates the FDA's inclusion of Section III(F) "Special Case: Administration of Drug Product and Vehicle Mixtures via Feeding Tubes," which directly impacts our members and is well-designed to enhance patient care. We are pleased to see the tube feeding administration guidelines that state the amount of liquid that must be flushed post administration to avoid blocked tubes. We agree with and support the specified volume of small amounts of liquid as the vehicle of 5-15 mL, and support guidance specifying that the medication should not impact patient satiety or the intake of caloric foods.
The Academy supports the Draft Guidance's recognition that, "If a certain liquid or soft food is considered unsuitable for the targeted patient population, even if the proposed vehicle(s) and the intact or manipulated drug product are chemically compatible, the indicated soft food or liquid may not be considered an acceptable vehicle for use. For example, adding a drug product to applesauce or another soft food is inappropriate if the targeted patient population is infants who are not yet eating solid food." We agree that, "Such data, when available, for liquids and soft foods evaluated and found to be unacceptable should also be submitted, including the rationale for avoiding their use as vehicles."
As many individuals unable to swallow pills have dysphagia, we respectfully recommend any liquids or solids to be used as a drug vehicle be tested and labeled in conformance with International Dysphagia Diet Standards (IDDSI), which would allow clinicians, patients, and caregivers clarity when utilizing these guidelines for individuals with dysphagia.
Yes. In general yes, but we have some suggested additions/considerations:
- In the tube feeding section (Draft page 8 Section F): Manufacturers should provide guidance if administration warnings about tube capability would be different if using a small bore vs a large bore feeding tube, and the location of the distal end of the feeding tube should be considered (i.e. medication that needs to be delivered to the stomach but the feeding tube is in the duodenum or jejunum)
- There should be mention of the International Dysphagia Diet Standardization Initiative (IDDSI) that the Academy has endorsed. Many of the foods listed will be assigned a number/level on the IDDSI classification. Patient and consumer safety should be safeguarded by the manufacturer indicating how their proposed modifications by adding medications to the food or fluid might affect the IDDSI classification. Since the population targeted by this is those people with swallowing challenges, it makes sense that IDDSI classification will become more of an issue in this population.
- For those with diabetes: we realize *most* of the time small volumes of food or fluid are recommended for mixing with meds. But at what point do we ask drug manufacturers to start considering the CHO content of their recommended delivery vehicle? We would like to see the amount of carbohydrates provided by dosage for patients with diabetes. If the vehicle used is sugar or other carbohydrates, this may be important in proper disease management.
- We would also encourage labeling of ingredients for those with allergies. The paper does speak about allergies in line 139 when it comes to the selection of the vehicle, but it should also be listed in the guidelines for labeling if it isn’t already noted. This would also be important in those with metabolic illnesses.We appreciate the inclusion of the provision of medications via tube feeding. Agree and support the volume for the vehicle of 5-15 mL. The medication should not impact satiety and the intake of caloric foods. We are pleased to see the tube feeding administration guidelines that state the amount of liquid that must be flushed post administration to avoid blocked tubes.
The Academy supports the FDA's draft guidance and encourages the FDA to consider the clarifications suggested above as its finalizes its guidance. Please contact either Jeanne Blankenship by telephone at 312/899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202/775-8277, ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, JD
Sr. Director, Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 NDTRs are educated and trained at the technical level of nutrition and dietetics practice for the delivery of safe, culturally competent, quality food and nutrition services. They are nationally credentialed and are an integral part of health care and foodservice management teams. They work under the supervision of a registered dietitian nutritionist when in direct patient/client nutrition care; and often work independently in providing general nutrition education to healthy populations.
3 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process focused on prevention, delay or management of diseases and conditions, and involves an in-depth assessment, periodic re-assessment and intervention. [Academy of Nutrition and Dietetics' Definition of Terms list, http://www.eatright.org/scope/, accessed 2 April 2014.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.