| Comment Record |
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Commentor |
Dr. Paul G King |
Date/Time |
2003-03-01 04:00:32 |
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Organization |
F.A.M.E. Systems |
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Category |
Other |
| Comments for FDA General |
| Questions |
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1. General Comments
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1. Oddly, the FDA site reference in the FR notice of 27
February 2003 is to an unsupported and unavailable link
www.fda.gov/bbs/topics/NEWS/2002/NEW00829.html.
2. Re: Science-based policies and standards
Before attempting to incorporate up-to-date science,
the agency first needs to address the fundamental
science that the regulations presently embody but, for
whatever reasons, the agency has seemingly overlooked.
Specifically I refer to the: a) ubiquitous, but ignored
requirements that all samples inspected (sampled and
tested) must be representative of the batch, b) require-
ment that statistical quality control be used to accept
or reject each batch of drug product for release, c) re-
quirement that there be statistically based in-process
monitoring of all in-process steps that can effect drug
product quality including uniformity assessment, and d)
the use of specific identity tests when such exist to
name a few of the fundamentals of good analytical science
that seem to be ignored.
3. If your approaches are to be science-based, then the FDA
must make certain that the science it uses is sound.
Today, the science that many in the industry or paid
by the industry present to the agency is, at best, based
on the misapplication or incomplete application of the
fundamentals of the applied science appertaining to a
truly quality-based approach inspection of a batch of
drug product for its key variable distributional factors
(for active and active availability) that properly de-
termine whether a given batch is, or is not, acceptable
for release to the market.
4. In my mind it is less than efficient to conflict a group
with conflicting imperatives. Yet, the agency is
forming a key group of inspectors that are to:
a) oversee PAI inspections and b) the inspection of
those firms whose histroy indicates a need for increased
oversight -- while assuring the industry that their
PAI inspections will be timely and, practically, tell-
ing the public, that the other inspections will not be
timely given the agency's budgetary constraints.
5. Though the agency cites resource constraints as justifi-
cation for its on-going failure to meet its statutory
obligation to inspect each drug manufacturer not less
than bi-annually, the reality is that it is the agency's
allocation of resources to programs that have no such
statutory mandates but benefit industry and not the
public or public safety that interferes with its meeting
its statuatory inspection mandate. It is, in general,
not in the public interest to have more me too
lifetime treatment alternatives that can be hawked to
the public and fewer and fewer disease cures - after
all it is far more beneficial to the drug industry
to develop a better (usually, more expensive treatment
product) than a product that cure the disease.
6. In spite of the agency's avowed systems approach to
inspection and its other initiatives, the track record
for the industry it regulates indicates a trend away
from compliance and an increasing lack of concern about
the safety and efficacy of each batch of each of the
products marketed. In spite of the agency's rhetoric
and perhaps because of its decreasing inspectional
oversight, the public is not being protected -- Bayer's
actions with respect to Baycol, Schering-Plough's will-
ful release of defective batches of inhalers, Roche's
being allowed to continue to profit from the sale of
Accutane even though they obtained agency approval by
deliberately concealing a key report on its CNS effects
are but a few of the more egregious examples that come
to mind. Though the agency and the industry are quick
to point to the imputed lives saved, the reality of the
increasing number of members of the public that are
irreparably damaged or killed is blithely attributed to
the weighing of the risk against the benefit. This
approach might be acceptable if those that take the
risk accrued the benefit -- however, as the dollars
indicate, the industry benefits, the public takes the
risk, and the industry is increasingly allowed to
decide what information it will disclose and when it
will disclose it -- the law and the public be damned.
The public's reward is to be told that damage awards
need to be capped while the those in the drug and
healthcare industries deserve to to be able to profit
without any cap and with decreasing oversight. The
public would be better served if the FDA simply were
to start enforcing the laws that are on the books but,
in the main, have gone unenforced for more than a quar-
ter of a century.
Hopefully, if the FDA truly wants to protect the public, it
will change its programs in a manner that the risk currently
borne by the public for the most part will be at least
adjusted to the point that it is shared equally by the
public and the industry.
Yet there is one irony that comforts me, the current
real risk that the prescription each person gets will
damage or lead to the death of the person who takes it
is shared by all in our society -- from the pauper to
the richest and most powerful persons in the US -- only
in America.
None of us can tell by looking whether, or not, the
pill we take today: a) contains the labeled amount of
active or b) the level of active contained will be
available to us as it is supposed to be.
Perhaps that is why the industry is more than happy to
spend whatever it takes to make sure that each of our
pills look good (using science-based statistical
product appearance control) but not to spend even the
minimum required by law to guarantee that each pill
in each batch of those good-looking pills will meet
the science-based content and content release standards
mandated by 21 CFR 211.165(d) (statistical quality
control).
Please get back to me if you need any clarification of the
comments I have made.
Thank you for providing me an opportunity to comment.
When you hold hearings on this approach, I hope that
you will invite me to share what little I can in this matter.
Respectfully submitted on 1 March 2003 as a formal
comment to Docket 03N-0059 - Pharmaceutical Current
Good Manufacturing Practices for the 21st Century:
A Risk-Based Approach
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