![](media/image1.jpeg){width="1.35in"
height="1.3597222222222223in"}**NATIONAL CONSUMERS LEAGUE**

> 1701 K Street, NW, Suite 1200, Washington, DC 20006

**[PHONE]{.smallcaps}** (202) 835-3323 **FAX** (202) 835-0747
[***www.nclnet.org***](http://www.nclnet.org/)

January 6, 2006

# BY ELECTRONIC MAIL

<http://www.fda.gov/dockets/ecomments>

Division of Dockets Management (HFA --305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

COMMENTS OF THE NATIONAL CONSUMERS LEAGUE TO

DKT. No. 2005N-0394

COMMUNICATION OF DRUG SAFETY INFORMATION

The National Consumers League (NCL) is a private, nonprofit advocacy
group representing consumers on marketplace and workplace issues. We are
the nation's oldest consumer organization. NCL provides government,
businesses, and other organizations with the consumer's perspective on
concerns including child labor, privacy, food safety, and healthcare,
including medication information. Our mission is to protect and promote
social and economic justice for consumers and workers in the United
States and abroad.

NCL has long been involved in issues of healthcare and monitors
rulemakings and legislation involving health issues, provides and
participates in patient education on medication and disease awareness,
and researches factors that influence the provision of medical services
to patients.

NCL has worked extensively and specifically in the issues surrounding
communication of information to consumers about the drugs they take. Our
research, educational activities, and advocacy have included:

-   Reporting upon best practices in pharmacies to protect consumer
    privacy;

-   Consumer education on pain relievers and on aspirin therapy

-   Instruction on how to read an over-the-counter drug label;

-   Awareness campaign for Attention Deficit/Hyperactivity Disorder;

-   Testimony regarding COX-2 inhibitors;

-   Testimony regarding methamphetamine manufacture;

-   Publication of a Consumer Guide To Generic Drugs and a Cholesterol
    Fact Sheet;

-   Instruction on how consumers can avoid counterfeit drugs

-   Managing SOS Rx, a coalition on safe use of drugs in the outpatient
    setting; and

-   Information to consumers on food -- drug interactions.

Furthermore, NCL is a member of the Board of Directors of the National
Council on Patient Education and Information (NCPIE), a coalition of
over 125 organizations whose mission is to stimulate and improve
communication of information on appropriate medicine use to consumers
and healthcare professionals. NCL was one of the participants on the
Steering Committee for the Collaborative Development of a Long-Range
Action Plan for the Provision of Useful Prescription Medicine
Information -- the Committee that ultimately submitted to The Honorable
Donna E. Shalala an "Action Plan" (or "Keystone Report") for meeting the
Public Law's targets for dissemination of useful information to
patients.

NCL is pleased to submit comments on the FDA's current risk
communication tools for prescription drugs, as outlined in the Federal
Register Notice. While we commend FDA for undertaking this effort to
improve risk information for drugs marketed and sold in the United
States, we have identified several areas of concern. We will be focusing
these comments on the Patient Information Sheets*,* and addressing some
of the questions posed in the Federal Register around the following
issues -- coordination of all information sources, harmonization of
information format and content, and communication of useful risk
information.

**1. Coordination of all FDA information sources**

NCL believes it is vitally important for the FDA to coordinate **all**
of its patient information materials. This is necessary both to avoid
overloading consumers with vast amounts of potentially conflicting or
duplicative information, and to ensure that the information provided is
clear and readable. If the Patient Information Sheets are going to be
produced for all approved drugs, even those that do not have an
"emerging safety" issue, it is important that their purpose and utility
is clarified. We would ask FDA to clarify the development and utility of
the Patient Information Sheet, including its relationship to other
written information consumers routinely receive with prescription
medicines at community pharmacies.

If, however, the Patient Sheets are properly integrated with other
sources, they could provide consumers with a valuable tool. Consumers
would be well served, for example, by having access to a single web
source with a complete (frequently updated) and consistently formatted
information sheet for all medications. The sheets could be searchable by
indication, class or specific product name, and would facilitate
consumers' ability to compare medications across a variety of important
domains.

**2. Specific issues regarding the Patient Information Sheet**

The FDA has specifically asked about the strengths and weaknesses of the
Patient Information Sheets. While we commend the FDA for developing
medication information summaries that are, for the most part,
understandable and easy to read, we have noted several weaknesses.

First, we ask that the FDA ensure that each Patient Information Sheet
has the same format for conveying information. The sample Patient Sheet
referred to in the Federal Register for Adderall, did not contain a
section on what patients should ask of their health care provider. Other
sheets did not specifically contain a section on "What are the Risks"
(Naproxen). It is helpful for consumers to have a similar format for
each medication, so they will know what information can be expected, and
that certain questions will be answered. In cases where a specific
section is not relevant, it is better to have the category left blank
(with notes acknowledging as much) as opposed to altering formats.

Secondly, there appears to be no mention of additional resources or
references to which patients might turn for more (or related) risk and
adverse event information. For example, a patient may not understand or
appreciate the potential risks associated with renal failure or liver
failure, and should therefore be directed to a resource where they could
learn more about these risks.

Third, the Patient Information Sheets do not encourage patients to
report their adverse events to the MedWatch system. Given the woefully
inadequate information we have about how drug products perform on real
populations once approved, FDA should be encouraging patients to use
MedWatch to report their adverse events.

The current MedWatch system, which relies primarily on adverse event
data reported by drug manufacturers and -- to a lesser extent -
physicians, is underused. FDA has admitted that the present system
yields only a small percentage of the total adverse events experienced.
In order to obtain more realistic rates of adverse events, the FDA
should actively encourage reporting directly from patients. To achieve
this, FDA needs to add a consumer portal to the existing system, and
then promote the system's new features to consumers**.** As part of this
effort, FDA should revamp both the telephone and Internet interfaces to
make them more user-friendly, and develop a separate event report form
that is easier for consumers to use.

The Patient Information Sheets provide an excellent opportunity to
promote the Medwatch system**.** These Sheets could direct patients to
report adverse events to their health care professional but would also
provide consumers with the Medwatch Web address and toll free number to
encourage direct reporting.

**3. The FDA also asked in the Federal Register "Do these tools provide
the right kind and amount of risk and other information that the public
and health care professionals need to make informed decisions about
whether to use these products?"**

a\) Is this the right kind of risk information for the public?

As with all patient medication information, it is important to convey
the risk information in a way that does not create unreasonable fear
resulting in patients not taking needed drugs. Patients need to
understand that the risk for an individual person will vary depending on
whether certain risk factors are present -- and their health care
provider can help them determine what is right for them. However, upon
reading that Advair may increase the chance of asthma death in some
people, (and without a definition of who "some people" are), it is
likely some patients may immediately stop taking the medication. FDA may
want to consider adding a statement in the Patient Information Sheet,
after the alert information, that patients should not stop or change
medication until they have consulted their health care professional.

We have recently heard first hand how when risk information is
misinterpreted, the results can be harmful to patients. This past
October NCL held a symposium on communicating child health risks and the
challenges of conveying and understanding research findings related to
often-controversial child health issues. For example, we heard from
physicians about their frustration when pediatric patients suddenly went
off Elidel, a skin cream used to treat dermatitis that was linked with
skin cancer. While the children's skin condition became much worse and
they suffered tremendously, doctors were frustrated because the risk of
cancer from the use of Elidel was, as FDA stated, "uncertain." There was
consensus among the researchers, journalists, and others attending the
symposium that all parties -- including the FDA - need to do a better
job of explaining that our scientific knowledge base with respect to
particular drugs and diseases is never static. We are always adding to
our knowledge, but have to make the best decision possible based on
existing research. To help communicate this level of nuance, the Agency
might wish to provide more information in the Patient Sheets about the
studies that serve as the basis for the FDA alerts, and refer patients
to other sources (such as the Health Care Professional Sheets and/or
other partner sites that contain more detailed information on the
studies). Ideally, one would like also to be able to point consumers to
a centralized, NIH-managed database of all completed clinical trials --
searchable by disease area, product class, and drug name. But this is a
point for another set of comments.

b\) Is this the right kind of risk information for health care
professionals?

The health care professional should be an integral part of any patient
education process, including education on medication use and associated
benefits and risks. In our work with SOS Rx, a coalition of over 80
organizations focusing on improving outpatient medication safety, the
health care professional is an integral part of an education campaign
focusing on a high-risk medication -- oral anticoagulants.

To better understand the challenges patients, clinicians and caregivers
face when managing oral anticoagulants, the coalition conducted focus
groups and surveys of patients on this medication, as well as clinicians
and caregivers. The research revealed that there are gaps in health care
management of patients on oral anticoagulants that expose patients to
serious and often unnecessary risks. Clinicians indicated that better
patient information and more time spent on patient counseling could help
minimize this risk. Based on this research, the SOS Rx education
materials for health care professionals will be integrated with the
patient materials. Patients will be educated about the key questions
they need to be asking their health care professional, and, in order to
respond appropriately, the health care professional will have patient
education material at their disposal in order to answer their questions.

In the same way, the FDA's Patient Information Sheets must be integrated
with the Health Care Professional Sheets. The Professional Sheets should
specifically refer the reader to the Patient Sheets, and, most
importantly, include specific questions (and answers) that the health
care professionals should share with their patients -- such as - do they
know the risks associated with the medication? What other medications
and behaviors can effect them? After reading the Patient Information
Sheets, patients may very well ask the questions that are posed on the
sheets, and the health care professional should be prepared to answer
them for the individual patient in a way that is clear and
understandable.

We remind the FDA that one of the stated goals of Healthy People 2010 is
to "increase the proportion of patients who receive verbal counseling
from prescribers and pharmacists on the appropriate use and potential
risk of medications." Section 17.5. Prescribers and pharmacists could be
encouraged to use the Patient Information Sheets as a basis for verbal
counseling of their patients.

**4. Finally, FDA asked for comment on the specific mechanisms it should
consider using to convey risk information, particularly to special
populations.**

First, it is unclear how the agency plans to disseminate this
information to the general public, let alone special populations. Will
the Sheets be printed off at the pharmacy, given out by physicians, only
accessed through the Internet? We once again ask that the FDA coordinate
the dissemination of the Patient Information Sheets with other
medication information.

Given that, only having access to the Patient Sheets through the
Internet will limit its utility and effectiveness for some of the
populations that need it most. Seniors are taking more drugs than ever,
and are often on multiple prescriptions (not to mention OTCs and dietary
supplements). Although Internet use is expanding, less than a third of
seniors (age 65 and over) have ever gone online.[^1] FDA should not just
rely on the Internet -- but use pharmacists, family caregivers, and
health care professionals to convey information to seniors. The FDA may
also want to consider running Public Service Announcements (on both
radio and television) announcing the existence of a new centralized
resource for consumers to get information about the prescription
medications they take. The PSAs could point people to the FDA Web site,
but also mention FDA partner organizations/resources that would help
people get the information they need.

\*\*\*

In closing, NCL is encouraged that FDA is seeking to improve risk
communication to patients, and we appreciate this opportunity to
comment.

Sincerely,

![](media/image2.jpeg){width="2.498611111111111in"
height="0.8722222222222222in"}

LINDA F. GOLODNER

President

[^1]: Kaiser Family Foundation Survey of How Seniors Use the Internet,
    2005.