February 11, 2006

To: FDA Center for Drug Evaluation and Research (CDER)

From: Karen M. Hicks, Founder, Dalkon Shield Information Network, Inc.

Re: Docket Number 2005N-0354

Consumer Directed Promotion of Regulated Medical Products

I respectfully submit this document to propose an alternative system to
direct-to-consumer (DTC) advertising for disseminating
critically-important information and education to consumers/patients on
disease conditions and the entire range of efficacious and safe
treatment options approved by the FDA. The burgeoning disclosure of
severe risks associated with drugs advertised widely and directly to the
American public demand urgent action to contain the problem. Just today,
news of an FDA advisory panel's conclusions about the serious problems
associated with attention-deficit drugs confirm the compelling problems
with DTCA.

On the homepage of the Pharmaceutical Research and Manufacturers of
America (PhRMA), the industry's primary trade organization
([www.phrma.org/dtc/index.html](http://www.phrma.org/dtc/index.html)),
the following quote articulates the industry's position on DTC
advertising:

*"PhRMA member companies understand that accurate information about
disease and treatment options makes patients and doctors better
partners. **And getting that information to doctors and patients is the
goal of DTC prescription medicine advertising *****\[emphasis
added\]***. DTC advertising increases people's awareness of diseases and
available treatments. Studies show DTC advertising brings patients into
their doctor's office and starts important doctor-patient conversations
about health that might otherwise not have happened."*

I reject this claim. The true goal of DTC advertising is to raise
awareness of a company's proprietary treatment for disease or disease
prevention. Advertising's goal, generally, is to persuade consumers to
purchase a specific product. The official definition of advertising,
according to the Encarta dictionary, is: "the promotion through public
announcements in newspapers or on the radio, television, or Internet of
something such as a product, service, event, or vacancy in order to
attract or increase interest in it." DTC advertising capitalizes on the
consumer role in medical decision-making and creates a selective market
for new drugs.

Written or broadcast materials from the parties who engage in
self-interest profit-making businesses should not provide the tools that
the public needs to make fully-informed decisions about how to treat
their health conditions.

I call for the establishment of a national registry and database that
all citizens can access readily to inform themselves about all drugs and
medical devices used or proposed for use in the U.S.

The registry would include the following components:

1\. a registration system that would allow consumers, *voluntarily*, to
sign up and certify their use of any prescription drug or device. This
registration would benefit consumers in the following ways:

a\. they could be contacted to participate in periodic reporting of
their experience with a prescribed drug(s);

b\. they could be notified in the issuing of timely warnings that may
arise;

c\. they would obtain a direct link to the FDA Medwatch program, which
would ensure their timely reporting of any adverse drug reactions
(ADRs).

2\. an organized and user friendly method of searching and retrieving
information on disease conditions, including the full range of treatment
options, that are currently available from the NIH, NIMH, the CDC and
other related governmental agencies that maintain educational materials
on health conditions;

3\. consumer/user friendly access to the vast storehouse of FDA
resources that are currently available:

a\. all drug application and review materials submitted to the FDA
during the initial drug review process;

b\. hearing notices and transcripts of all meetings involving drug or
devices;

c\. all post-approval surveillance and safety information and recalls.

The critical aspect of this system is the guarantee of universal and
user-friendly access for all citizens. This public service should be
available on the Internet AND at "kiosks" located physically in
pharmacies and other retail outlets, preferably adjacent to pharmacists,
the health care professionals with the most skilled, up-to-date and
sophisticated understanding and knowledge of the benefits and risks of
FDA-approved drugs. The "kiosk" or booth, would be similar in design to
what we now have for airport check-ins and do-it-yourself photo
processing. Such kiosks would have touch screens and direct the user to
a user-friendly menu of options described above.

Furthermore, every prescription, pill bottle and patient information
sheet would include an Internet address that "advertises" this registry
system, informing all consumers how to access the registry from their
personal computer or from a store's kiosk.

Because the principle goal of this system is a public service, it should
be located in a governmental agency, most logically within the FDA.
Sadly, the highly publicized problems of slowness to response and undue
pharmaceutical pressure and influence in weakening consumer protections
at the FDA makes it unsuitable and undesirable as the most responsible
authority at this time.

When DTCAs first appeared in 1997, some leading consumer health
advocates hailed this as a great leap forward in increasing patient
empowerment relative to their doctors. In the 8 years since then, the
real outcome appears not to have accomplished that goal.. In documents
submitted to this committee by other parties, an enumeration of all the
problems of DTC advertising have undoubtedly been acknowledged.
Education and information about disease and treatment options is a
profound and challenging task that should not be left to the firms vying
for profits in products they are financial invested in. Responsibility
for disease awareness information and education on how to understand a
disease state and evaluate the best treatment for someone with that
disease is best left to an entity that does not have profit-making as a
prime motive. People who filled prescriptions for these drugs should not
have to find out about problems being disclosed in the same news outlets
that once ran slick ads to convince them to ask their doctors about
using these drugs.