FDA Safety Oversight

An independent Drug Safety Oversight Board (DSB) has been established to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits. ^[2]

The Board's role will be advisory. It will not have the authority to remove a drug from the market or make changes to its sales practices.^[3]

“The public has spoken and they want more oversight and openness," Health and Human Services Secretary Mike Leavitt said. "They want to know what we know, what we do with the information and why we do it.” ^[2]

The launch of new, direct communication channels will enable the FDA to share with the public emerging or potential safety issues before they prompt a regulatory action, enabling patients and their doctors to make better-informed decisions about treatment options. These channels are:

• A Drug Watch Web page, which will identify previously and newly approved drugs for which the FDA is “actively evaluating early safety signals." It will include information about “possible serious side effects or other safety risks that have the potential to alter the benefit/risk analysis of a drug, affect patient selection or monitoring decisions, or that can be avoided through measures taken to prevent or mitigate harm.”^[2] The Board will place a drug or class of drugs on Drug Watch after a preliminary review of safety information determines further investigation is warranted. Drugs will be removed from the watch list as soon as safety concerns are resolved.
• Healthcare Professional Information Sheets, which will focus on the most important new information for the safe and effective use of all drugs on Drug Watch and with Medication Guides (FDA-approved patient labeling). Information will include known and potential safety issues based on reports of adverse events, new information that may affect prescribing of the drug, and the approved indications and benefits of the drug.
• Patient Information Sheets, which will highlight new safety information as well as basic information about how to use all products on Drug Watch.

"If we have information and there's not a reason legally for it to be protected, we need to put it in the public domain," said Secretary Leavitt.^[3]

The DSB’s other responsibilities include:[1]

• Identifying, tracking, and overseeing the management of important drug safety issues.
• Adjudicating organizational disputes concerning the management of drug safety issues.
• Establishing policies regarding management of drug safety issues in CDER.
• Selecting drugs to be placed on Drug Watch and update their status, including determining when a drug should be removed from Drug Watch.
• Overseeing the development of patient and professional information sheets.
• Tracking important emerging safety issues and ensuring that they are resolved in a timely manner.
• Ensure that decisions about a drug’s safety benefit from the input and perspective of experts within and outside FDA who have not conducted the primary review or served as a deciding official in the ongoing pre-market evaluation or post-market surveillance activities with respect to that drug. The Board has the authority to consult outside experts, including patient and consumer representatives, as it deems appropriate in specific matters.

The Parkinson’s Pipeline Project is committed to ensuring that patients and their real life experiences are given a voice in deliberations of benefits and risks. There is great concern that clinical trials for promising drugs, like GDNF, will be prematurely halted and effective marketed drugs pulled from the drugstores, without a clear understanding of their benefits/risk ratio for the patients who will be affected. Patients know what it is like to live with a disease, and can best assess the risks they are willing to take. This is especially crucial for those suffering with life-threatening and debilitating diseases, with no other treatment alternatives.

Sources

[1] Manual Of Policies And Procedures, Center For Drug Evaluation And Research, Office of the Center Director, Drug Oversight Board

[2] News-Medical.Net, February 16, 2005; FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues

[3] Safety Kaiser Network.org Daily Health Report, Feb 16, 2005; FDA To Create New Independent Oversight Board To Monitor Prescription Drug

[4] FDA Fact sheet : FDA improvements in drug safety monitoring; Feb. 5, 2005

Copyright © 2004-2006 Parkinson Pipeline Project.

All rights reserved. Revised: 05/24/07.