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Statement of Steven K. Galson,
M.D., M.P.H., Regarding Unapproved Prescription Drugs, June 8, 2006
Good morning. As you’ve read in Dr. Von Eschenbach’s
statement, the agency has significant public health concerns about
marketed unapproved prescription drugs. Unapproved prescription
drugs may not meet modern standards for safety, effectiveness,
quality, and labeling. Tackling this problem should be seen as
integral to the comprehensive drug safety efforts we have
implemented over the last year.
As I know you are aware, the agency launched a broad initiative last
year to ensure that consumers and the health care community get
up-to-date drug safety information, so that they can make the best
possible decisions about how to use drugs. The efforts we are
announcing today emphasize FDA’s commitment to providing the
American public with safe and effective drugs. While the FDA drug
approval system is widely recognized for bringing safe and effective
new drugs to the market, it is unfortunate that many older or
existing drug products continue to be marketed in this country
without required FDA approval. While this may come as a surprise to
many, particularly in a year in which FDA celebrates 100 years of
protecting the public health, we consider it a significant and
serious drug safety issue that must be addressed since these
products may pose risks to consumers.
The presence of unapproved prescription drugs on the U.S. market is
in stark contrast to our current approach to drug safety. First,
healthcare providers and consumers may not be able to recognize
these products as lacking required FDA approval. These products may
be included in widely used pharmaceutical reference materials such
as the Physicians’ Desk Reference or advertised in medical journals.
This means that healthcare providers cannot assume that drugs they
may prescribe have been found by FDA to be safe and effective. They
cannot assume that the product labeling has undergone scrutiny to
ensure the appropriateness of its indications and directions for
use, and they cannot rest assured that claims that a product is safe
for use in children or other especially vulnerable populations are
supported by sound scientific evidence. There may also be a lack of
assurance that the product formulation and manufacturing practice
standards will produce a safe and effective product. The product may
be substandard, and it may not have the required identity, strength,
and purity.
The Marketed Unapproved Drugs compliance policy guide, issued today,
is a significant step forward. It outlines a prioritized, risk-based
enforcement approach encouraging companies currently manufacturing
drugs without required FDA approval to comply with the drug approval
process and ensure the safety and efficacy of their marketed
products. This guidance clearly articulates FDA’s expectation that
manufacturers of products requiring FDA approval submit applications
to FDA to show that their products are safe and effective. At the
same time, the guidance discusses the approach the agency will use
to efficiently and rationally bring such drugs into the approval
process. The highest priorities for enforcement action will continue
to include drugs with potential safety risks, drugs that lack
evidence of effectiveness, and health fraud drugs. FDA will proceed
on a case-by-case basis with these priorities in mind, with every
effort made to avoid adversely affecting public health, imposing
undue burdens on consumers, or unnecessarily disrupting the drug
supply.
FDA has been working on the unapproved drugs issue steadily through
the years. The issuance of this CPG demonstrates our renewed
emphasis on this issue. Today, we are announcing that this is a
significant focus for us going forward.
Our action against unapproved carbinoxamine products illustrates why
unapproved drugs are a problem. FDA has serious safety concerns
about use of carbinoxamine-containing products in children under the
age of 2. Yet, numerous unapproved products containing carbinoxamine
are specifically labeled for use in children as young as one month
of age and many of these products are actually formulated and sold
as infant drops. Also, although approved versions of carbinoxamine
have been found effective for various allergic symptoms, some
unapproved carbinoxamine products are labeled for treatment of cough
and cold symptoms, an indication for which carbinoxamine has never
been found safe and effective by FDA. All of this needs to change.
At FDA, providing the American public with safe and effective
medical products is our core mission. Making sure that all marketed
drugs have required FDA approval is a key part of that.
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Unapproved Marketed Drugs
Date created: June 9, 2006 |
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