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FDA’s proposed changes to drug safety program

November 5, 2004

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:

(1) 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.

(2) 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.

(3) 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.

(4) 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.

(5) 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.