Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All”

September 9, 2013
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852


Comments of the Patient, Consumer and Public Health Coalition
to FDA on “Ensuring Access to Adequate Information on Medical Products for All”
Docket No. FDA-2013-N-0757


As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations.

However, the plans as outlined in the report are not specific enough to provide meaningful information about how these efforts will be implemented.  The devil is in the details, and there are very few details in this FDA report.

The report does, however, provide several website links as examples of the FDA communications in “plain language” and we take this opportunity to provide general comments about several examples taken from those links.

These first two examples, both taken from the links provided by the FDA as examples of “plain language,” would be challenging to read for any college graduate, and very unlikely to be read by anyone who is not a college graduate.

  1. Here’s a sample paragraph from this link:

“The FDA received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa.  Each of these patients were examined with transesophageal ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel. Upon investigation, the ultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca.”

  1. Although easier to read, the following explanation of a recall could be worded much more simply, to make it understandable to more people.  “prolonged obstruction”

“Reason for Recall: Acclarent identified the potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. This product may cause serious adverse health consequences, including death.”

  1. The following article on metal on metal hip implants, also taken from one of FDA’s example links, is short and easier to read, but could be improved.  For example, many consumers would not know what “local and systemic complications” means.

  1. Although clearly intended for caregivers as well as health professionals, the following linked instructions about what to do if accidently stuck by a used needle or sharp could be worded more simply.  For example, why not say “contact your doctor or the closest hospital right away” instead of “Seek immediate medical attention by calling your physician or local hospital” and “follow this advice” instead of “follow these same instructions.”

Strategies such as simplifying language for individuals with low health literacy or translating information for individuals with limited English proficiency will make information on medical products easier to understand. This in turn will increase the safe and effective use of medical products in these subpopulations, which is a very important need.  Unfortunately, even the FDA’s examples of what the agency considers successful efforts would be difficult for many Americans to read and understand.

In addition, while creating communication strategies for providing medical product information is an important step in the right direction, there is a more fundamental problem: the lack of specific information about the safety and efficacy of many medical products for minority populations.   Minority groups and the elderly remain underrepresented in many clinical trials for drugs and devices being considered for approval by the FDA.   Since these trials determine FDA approval of medical products, as well as post-approval labeling of the products, obtaining knowledge about the safety and effectiveness for all groups via these trials is crucial.  Even when data are collected on demographic minorities, this information is rarely analyzed in subgroup analyses, and when they are, the results of subgroup analyses are rarely made available to the public or clearly described on the product label.

We urge the FDA to make better use of health educators to improve all the materials provided on the FDA web site, and especially those that patients and consumers might want to read and understand.  We strongly urge FDA to require safety and effectiveness evidence for demographic subgroups before approving medical products – only then can truly adequate information be communicated.


American Medical Students Association
American Medical Women’s Association
Breast Cancer Action
Connecticut Center for Patient Safety
National Committee to Preserve Social Security & Medicare
National Consumers League
National Research Center for Women & Families and the Cancer Prevention and Treatment Fund
The TMJ Association
Center for Science and Democracy, Union of Concerned Scientists
For more information, contact Paul Brown at (202) 223-4000 or