Michael Scott Smith - Comment

Firstly, I would like to congratulate the efforts of the Food and Drug Administration
(FDA) aimed increasing the transparency level of the disclosures made by FDA to
he general public. Unfortunately, over the past two decades that I have observed
FDA actions, all too often the decision-making process of the FDA has been
cloaked in a level of secrecy and a denial of access to appropriate information that
befits the CIA, rather than an organization charged with supporting its chief
stakeholders, the patient community of the United States, which takes the drugs
and utilizes the devices regulated by FDA. Although indvidual officials at FDA are
quite accomodating and cooperative with patients and patient groups, the
collective mindset of the organization is one in which the Agency feels that it is
working on behalf of unknowing patients and their doctors, rather than working in
conjunction with patients and doctors for better healhcare outcomes.
Transparency must not only be in words, but in actions. An effort that highlights
the need for transparency cannot be accompained by the continuation of past
practices at the FDA, but can be potentially changed with the help of those at the
hearing today, along with the following suggestions.
1. Development of an EDGAR-style database for drugs and devices: Most
importantly, the FDA can take the lead from actions taken by other Federal
regulatory agencies such as the SEC through the formation of an EDGAR
database for drugs and deivces. In the same manner that a stockholder can
quickly and freely can access to the Internet in order to get all possible
information on a company in which he or she is invested, FDA should develop an
EDGAR style database, which for each medicine and device that has been
federally licensed or is up for review in the US, contains a fullsome database
which contains:
a. An "initial registration" document which describes the potential uses
for drugs and devices up for clinical trial in the US.
b. An "10-K" style document which for drugs that are approved in the
US, updates the general public on a drug's potential uses, benefits and side
effects.
c. An "8-K" style document which upon the occurence of a sudden
change in a drug or device's status (i.e.-a black box warning or labeling change)
would inform users quickly and efficiently of important information.
d. A "terminated registration" filing which informs users of a drug that as
been withdrawn from the US market and the reasons behind withdrawal.
The Edgar database should be accompained with an "Alert" feature which can
email users upon changess applicable to drug or device status. Filings should be
provided in a "plain english" format so that users with a high school education of
average intelligence should be able to interpret the documents. The FDA should
offer online seminars or in-person seminars through their regional offices about the
uses of the database and a "how-to" on how consumers can best iunderstand the
benefits and risks tied to the drugs and devices they use every day.
2. Transparency in the Drug Approval/Drug Withdrawal Process: The patients
represented by G-PACT sufferred greatly upon the withdrawal from the US market
of a number drugs specifically tailored for their conditions such as Proplusid and
Zelnorm and the denial of entry into the US market of other medicines which could
potentially help their conditions. Complicating these withdrawal decisions is a
process by which, most particularly in the case of Zelnorm, the patient community
was provided with one day's notice of the drug's withdrawal from the US market.
All withdrawal decisions, unless accompained by an imminent and significant risk
of mortality must be accompained by 30 days prior written notice to the public at
large with specialized warnings to the medical communities using a particular
drug, prior to withdrawal from the US market. In addition, all withdrawals should
be accompained by hearings of the appropriate advisory panel of CDER in which
doctor and patient attendance or submission of comments is promoted during
such a 30 day period, to allow for a fullsome hearing of the potential benefits, risks
and alternatives to a drug or device being removed from the US market. Until this
happens, I feel that the right to adequate due process has been denied.
3. Consumer Group Access to FDA Proceedings: Over the years, frequent
criticism has been lodged by both those within FDA and outside of it, over the
involvement of the pharmaceutical industry and doctors and other medical
practioners who work with the drug and device industry over potential and actual
conflicts of interest that could shade regulatory decisions made by advisory
committees and ultimately the FDA. To be sure, certain of these conflicts can
and do exist and they may be inevitable given the fact that those that are
sometimes the most knowledgeable about medication ad device design and use
must work with industry to get their ideas in the open.
However, groups like Public Citizen have been at the forefront of attacking and
demonizing those who have conflict of interest issues, often at the cost of
legitimate innovation and research which enhance patient quality and care. These
criticisms are not fully altrustic, as such groups often publish revenue producing
newsletters (often which have articles that describe potential drug risks, which
users must subscribe to in order to receive), alerts which carry the ability to
quickly knock an effective drug off of the US market, and even offer course work to
future "activists" trained in the ways of such organizations to take their lead. It is
our hope that FDA balances out for the sake of transparency the conflicts faced
by industry with the potential and actual conflicts faced by groups such as Public
Citizen when weighing and seeking input from the general public. Often, the
patient community feels as if it is in the middle of such conflicts without an
advocate.
Thank you for your time and effort in this matter.
Sincerely,
Michael S. Smith
Director
G-PACT