E-drug: FDA and drug quality: response from FDA
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e-drug: Could you please circulate this message to the e-drug mailing list?
Many people have forwarded to me a message circulated yesterday on your list
by Jamie Love. Although I do not share his characterization of FDA's or my
positions at a TransAtlantic Consumer Dialogue meeting in Brussels last
September, I am glad he acknowledges the importance of drug quality and I
support his call for ideas about how better to assure the quality of drugs
moving in international trade. I also welcome the opening his email gives me
to raise with the broader e-drug community two of the issues I raised then
with TACD consumer groups.
One was drug quality, and the other was to explore whether TACD had an
interest in stimulating NGO participation in some of the drug delivery
infrastructure problems identified by many as one of the barriers to
pharmaceutical access to developing countries. Many NGOs have a presence in
developing countries, and some already are helping to solve the problem of
getting pharmaceuticals to people who need them. Particularly given the
attention to the HIV drugs issues in recent months by the two governmental
participants in TACD (the U.S. government and the European Commission), last
September we were wondering if TABD wished to continue its focus as one more
place for the intellectual property rights debate or whether it might
instead like to take on a broader role in helping to assess needs as to HIV
treatment in developing countries, particularly in Africa, and to identify
what TACD participants could do to meet these needs. On the latter point,
the U.S. and EU TACD representatives said they preferred to limit TACD to
discussions of issues about whether TRIPS-type trade agreements have an
adverse impact on pharmaceutical access (i.e., the familiar discussions
about compulsory licensing and parallel imports).
On drug quality, I encouraged TACD generally, and Mr. Love's organization
particularly, to be more attentive to issues of the quality of drugs moving
in international trade.This issue was and is being ignored. Concerns include
counterfeits and other drugs that are not what they are purported to be, and
drugs that are subpotent or superpotent. I did not mount "a blistering
attack on virtually all developing world products, without any evidence,
data, or really without any suggested fixes, other than to buy from big US
and EU companies."
Rather, my points in Brussels were that TACD advocates needed to pay more
attention to the drug quality issue, and that one simply cannot make
assumptions one way or the other about the quality of drugs moving in
international trade, without a factual basis for this view. FDA's experience
is that there is no way to assure drug quality without attention to current
good manufacturing practice regulations (GMPs) and the drug quality testing
and other checks associated with GMPs. FDA, as a national institution,
performs GMP inspections both within the U.S. and in foreign countries (many
of these are pre-approval inspections associated with drug approval
applications pending in FDA). Where FDA has inspected a facility and has
approved a product for the U.S. market, obviously it has some knowledge
about the compliance status of that firm and and some factual basis for a
view about the likely quality of the products that firm produces, day in and
day out. Equally obviously, If FDA has not inspected a facility and approved
a product for the U.S. market, FDA has no factual basis for offering advice
to anyone on the compliance status of the firm or the quality of its
products. That was my point. It should be noted that firms selling drugs on
the U.S. market include not only the large and well-known multinational
firms but also smaller and less famous generic firms marketing products in
the U.S. under FDA-approved full-blown or abbreviated applications in which
FDA GMP inspections preceded approvals.
Although FDA's focus is on domestic consumer protection, e-drug readers
should know that the agency has, over the years, made significant
contributions at the global level to raising drug quality, including
considerable assistance to WHO and developing countries concerning drug
quality and GMPs. Examples are our contributions to WHO normative work
(e.g., guidelines on drug GMPs and on multi-source drugs, product standards
for vaccines and other products, etc.). A couple of decades ago, FDA
stimulated the creation of the International Conference of Drug Regulatory
Authorities, a biennial forum for sharing information and experiences among
pharmaceutical regulators that has done much to strengthen developing
country regulatory systems. ICDRA is now affiliated with WHO. More
recently, FDA has worked with PAHO to form a hemisheric pharmaceutical
harmonization forum, in part to stimulate improved regulation of drug
quality among sister countries in the Americas, and the agency is planning
training on GMPs and inspections at the University of Puerto Rico to further
advance understanding and expertise on drug quality among counterparts in
other Americas countries.
FDA has also provided much bilateral training and technical assistance on
drug GMPs, inspections approvals, etc., and we are hopeful that these
regulatory cooperation efforts have contributed to quality of drugs produced
elsewhere, whether or not in facilities regulated by FDA. It should be
understood, however, that although FDA has an interest in and (subject
always to the usual resource shortage) a role to play in improving drug
quality both in the U.S. and abroad, FDA's mission does not include
"increasing confidence in generic products in developing countries." We are
regulators, not promotors. Concerning the global effort to tackle the issue
of HIV in Africa and elsewhere, FDA is as always supportive of strengthening
the regulatory infrastructure in other countries including those suffering
from HIV epidemic. However, we also recognize that regulatory infrastructure
reform does not occur overnight and that any effort to respond in the near
term to the HIV crisis in developing countries will likely involve provision
of drugs made and approved in countries other than the destination
countries.
So, a contribution FDA can make, and make today, is remind people of the
information available on www@fda.gov as to FDA-approved drugs. Others can
rely upon FDA's thorough and expert review of product submissions and our
inspections of the producers of these products. Donors then might find ways
to purchase or give these well-vetted drugs to the sick people who need
them, here or someplace else. As to products that haven't gone through the
FDA system, we lack a factual basis to address whether they possess the
requisite quality to do what they purport to do. Other national or
international institutions might choose to focus on assuring the quality of
products not examined by FDA and, though our parent Department of HHS, FDA
would expect to participate in discussions about this question. The e-drug
community may have some good ideas on this problem.
In sum, FDA's emphasis is one of public health, not of promoting any
particular set of players in the global pharmaceutical industry at the
expense of others. Thank you, e-drug, for this opportunity to contribute to
this discussion and correct any misunderstanding of my views and those of
FDA.
Linda R. Horton, Director
International Agreements
Office of International Programs
Office of International and Constituent Relations
Office of the Commissioner
U.S. Food and Drug Administration
(301) 827-3344
lhorton@oc.fda.gov
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