## ![](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/)

August 8, 2005

# BY ELECTRONIC MAIL

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

Division of Dockets Management (HFA --305)

Food and Drug Administration

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Rockville, MD 20852

COMMENTS OF THE NATIONAL CONSUMERS LEAGUE TO

DKT. No. 2005D-0062

DRAFT GUIDANCE FOR INDUSTRY ON THE FOOD AND DRUG ADMINISTRATION\'S DRUG
WATCH FOR EMERGING 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, 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 on issues surrounding communication of
information to consumers about the drugs they take. Furthermore, NCL
convenes a coalition of over 80 organizations called SOS Rx, which is
dedicated to improving outpatient medication safety. NCL also serves on
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 to the Food and Drug Administration
(FDA) on the Draft Guidance for industry on the food and drug
administration\'s drug watch for emerging drug safety information (the
Draft Guidance). We commend FDA for undertaking this effort to improve
drug safety post-marketing in the United States, as we believe the
current system does little to proactively inform patients and providers
of the relative risks new treatments for which there is limited safety
information. Creation of the Drug Watch system will increase
transparency of the ongoing post-market evaluation process, and
hopefully provide a useful tool for the general public and healthcare
professionals.

NCL is glad to see the Draft Guidance specify developing *Patient
Information Sheets* for **all** approved drugs, even those that do not
have an "emerging safety" section. It is our expectation that the Agency
will develop these sheets both for new products, as well as those that
have been on the market for several years. It is unclear, however, how
the agency plans to disseminate this information to consumers. If it is
to be anything more than a posting on the FDA Drug Watch website, it
will be vitally important for the agency to coordinate all of its
patient information materials according to the Action Plan requirements.
This is necessary both to avoid overloading consumers with vast amounts
of potentially conflicting information, and to ensure that the
information provided is clear and readable. The Action Plan included
several specific examples in Appendix G. We recommend that the FDA look
to these samples in the final guidance so that there is coordination of
the information that consumers receive.

\* \* \* \* \*

NCL has some concerns with regard to the Draft Guidance and questions
the extent to which the Drug Watch system -- as described in the Draft
Guidance - will provide sufficient value to consumers and providers.
While, a step in the right direction, we have identified several areas
of concern to which we would like to draw your attention.

**1. The Information Posted May be Too Vague to be Useful**

> Of particular concern to NCL is FDA's current thinking on what type of
> information to post about a particular product on the Drug Watch page.
> The three examples illustrated in this Draft Guidance appear too vague
> to be useful to patients and providers. While the Drug Watch site, by
> definition, will not be able to address all product safety concerns,
> it should provide visitors with as much useful information as
> possible.
>
> None of the examples provided in the Draft Guidance indicate how many
> events of a given type have been reported, by whom, or in which
> patient populations. Furthermore, there appears to be no mention of
> additional resources or references to which visitors of the site might
> turn for more (or related) adverse event information. For example, a
> patient reading about Drug "A" may not understand or appreciate the
> potential risks associated with renal failure, and should therefore be
> directed to a resource where they could learn more about it.
>
> **2. The Draft Guidance Provides Inadequate Timeframe and Follow-up
> Information**
>
> In addition to the lack of specific supporting data, the proposed
> information for posting does not appear to include adequate timeline
> information. Patients and providers wishing to make informed
> decisions, likely would want to know how long a product had been on
> the market, at what point the safety signals warranted FDA attention,
> and some estimate as to when FDA might expect to issue further
> information about the product. The current Guidance suggests using a
> disclaimer of:
>
> "This information reflects FDA's preliminary analysis of data
> concerning this drug. FDA is considering, but has not reached a final
> conclusion about, this information. FDA intends to update this web
> page when additional information or analyses become available."
>
> While understandable, this disclaimer gives no indication for how long
> a patient or provider may have to wait to learn more. Absent this
> historical context and plan for future updates, they will have only
> part of the information they need. For this reason, NCL recommends
> that FDA update the information page on a regular basis -- providing
> "best guess" estimates of when site users can expect more complete
> data. In addition, when adequate safety information becomes available
> such that products are removed from the web site, patients and
> providers should be directed to the latest sources of information
> about the product.
>
> **3. The Draft Guidance Does Not Make Sufficient Provission for
> Consumer and/or Patient Representation to the Drug Safety Oversight
> Board**

The Draft Guidance indicates that the purpose of the Drug Watch web page
is to "communicate significant emerging safety information about
specific drug products or classes of drug products." The Guidance goes
on to describe the process by which -- and the factors necessary to --
include a product in the system. NCL supports the proposed factors for
consideration, and the role of the Drug Safety Oversight Board (DSB) in
making the final determination of which products should be included.

The Guidance states that: "The Board also may engage as consultants the
chairs of FDA Advisory Committees and other external scientific experts,
as well as consumer and patient representatives to present their views
regarding emerging drug safety issues." However, this in no way
guarantees that the consumer perspective will be included in the
determination of whether and, if deemed necessary, how such product
information will be presented to consumers via the Drug Watch website.

> **4. The Draft Guidance Does Nothing to Improve the Quality and
> Quantity of Adverse Event Information Reported to the FDA**
>
> The Draft Guidance does nothing to address the underlying problem of
> our poor post-market surveillance and event reporting system. Despite
> the rigorous drug safety and effectiveness evaluation conducted
> pre-market in the US, we have woefully inadequate information about
> how drug products perform on real populations once approved. For this
> reason, we call on FDA to a) invest resources in the expansion and
> improvement of the MedWatch system, and b) require product sponsors to
> initiate and complete safety trials as deemed necessary by the new
> Drug Safety Oversight Board.

a)  The current MedWatch system relies primarily on adverse event data
    reported by drug manufacturers and physicians. However, the
    requirement of drug manufacturers to submit relevant events is
    severely constrained by the Agency's lack of authority and resources
    to audit records and impose penalties for non-compliance. Provider
    entries into the system also are insufficient, and should be
    supplemented with many more reports directly from patients. To
    achieve this, however, FDA needs to promote the system's features to
    consumers. As part of this effort, FDA should also 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.

b)  In recent reports from both the FDA and lawmakers, it has been
    revealed that -- as an unintended consequence of the "fast track"
    approval process - many sponsor companies either stall or forgo
    completion of their required post-marketing safety studies. It may
    be that this non-action is appropriate in certain circumstances, but
    it is also likely that the public health would be best served by
    having faster access to more complete drug safety information. To
    this end, NCL supports granting FDA the authority to require timely
    completion of these studies where appropriate, and the ability to
    impose restrictions and penalties for non-performance.

> \* \* \* \* \*
>
> NCL firmly believes that all of these proposed measures will improve
> upon the proposed Drug Watch system, and we thank FDA for this
> opportunity to comment.

Sincerely,

![](media/image2.jpeg){width="2.498611111111111in"
height="0.8756944444444444in"}

LINDA F. GOLODNER

President