FDA Statement
FOR IMMEDIATE RELEASE
Statement
November 5, 2004
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FDA Acts to Strengthen the Safety Program for Marketed Drugs
Dr. Lester M. Crawford, Acting FDA Commissioner, today issued the following
statement:
Modern drugs provide unmistakable and significant health benefits, but experience
has shown that the full magnitude of some potential risks have not always emerged
during the mandatory clinical trials conducted before approval that evaluate
these products for safety and effectiveness. Occasionally, serious adverse
effects are identified after approval either in post-marketing clinical trials
or through spontaneous reporting of adverse events. FDA has a drug safety program
designed to assess adverse events identified after approval for all of the
medical products it regulates. In this program, our clinical reviewers work
with our epidemiologists to evaluate and respond to identified concerns. This
is what occurred recently with anti-depressants and Vioxx.
Detecting, assessing, managing and communicating the risks and benefits of
prescription and over-the-counter drugs is a highly complex and demanding task.
FDA is determined to meet this challenge by employing cutting-edge science,
transparent policy, and sound decisions based on the advice of the best experts
in and out of the agency.
To this end, I have authorized our Center for Drug Evaluation and Research
(CDER) to take the following measures:
- Sponsor an Institute of Medicine (IOM) Study of the Drug Safety System:
An IOM committee, under an FDA contract, will study the effectiveness of
the United States drug safety system with emphasis on the post-market phase,
and assess what additional steps could be taken to learn more about the side
effects of drugs as they are actually used. The committee will examine FDA's
role within the health care delivery system and recommend measures to enhance
the confidence of Americans in the safety and effectiveness of their drugs.
- Implement a Program for Adjudicating Differences of Professional Opinion:
CDER
will formalize a program to provide an improved process to ensure that the
opinions of scientific reviewers are incorporated into its decision-making
process. In most cases, free and open discussion of scientific issues among
review teams, and with supervisors, managers and external advisors, leads to
an agreed course of action. Sometimes, however, a consensus decision cannot
be reached, and an employee may feel that his or her opinion was not adequately
considered.
Such disagreements can have a potentially significant public health
impact, so CDER's program provides for a review of the involved differing
professional opinions by FDA and outside experts. An ad hoc panel, whose
members were not directly involved in disputed decisions, will have 30 days
to review all relevant materials and recommend to the Center Director an
appropriate course of action.
- Appoint Director, Office of Drug Safety:
CDER will conduct a national
search to fill the currently vacant position of Director of the Office of
Drug Safety, which is responsible for overseeing the post-marketing safety
program for all drugs. The Center is seeking a candidate who is a nationally
recognized drug safety expert with knowledge of the basic science of drug
development and surveillance, and has a strong commitment to the protection
of public health.
- Conduct Drug Safety/Risk Management Consultations
In the coming year,
CDER will conduct workshops and Advisory Committee meetings to discuss complex
drug safety and risk management issues. These may include emerging concerns
for products that are investigational or already marketed. Examples of input
that might be sought include whether a particular safety concern alters the
risk to benefit balance of a drug; whether FDA should request a sponsor to
conduct a particular type of study to further address an issue; what types
of studies would best answer the question; whether a finding is unique to
one product or seems to be a drug class effect; whether a labeling change
is warranted and, if so, what type, and how to otherwise facilitate careful
and informed use of a drug.
These consultations will include experts from
FDA, other federal agencies, academia, the pharmaceutical industry and the
healthcare community.
- Publish Risk Management Guidances
By the end of this year, FDA intends
to publish final versions of three guidances that have been developed by
our agency to help pharmaceutical firms manage risks involving drugs and
biological products. These documents are "Premarketing
Guidance," covering risk assessment of pharmaceuticals prior to their
marketing; "RiskMAP Guidance," which deals with the development and
use of risk-minimization action plans; and "Pharmacovigilance Guidance," which
discusses post-marketing risk assessment, good pharmacovigilance practices
and pharmacoepidemiologic assessment.
These guidances, which were first issued as draft guidances in May, 2004,
are designed to assist manufacturers in the management and minimization of
risks of pharmaceutical products throughout their life cycle.
These guidances should assist pharmaceutical firms in identifying and assessing
potential safety risks before a drug reaches the market and also after a drug
is already on the market using good pharmacovigilance practices and pharmacoepidemiologic
assessment.
I am satisfied that these additional activities will strengthen the agency's
program to greater ensure the safety of medical products that are making a
major contribution to the health and quality of life of millions of Americans.
Medicines that receive FDA approval are among the safest in the world; the
measures we are taking are designed to strengthen this quality as well as our
consumers' confidence that FDA's processes ensure the highest protection of
the public health.
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