For Pharmaceuticals:

New FDA Guidance Aims to Strike a Balance Between Risks and Benefits of Drugs


FDA to Provide Emerging Drug Safety Information

The FDA has issued a new guidance that addresses the scarcity of information about the safety of prescription drugs after they are approved.

According to the final guidance titled ?Drug Safety Information - FDA's Communication to the Public,? the FDA will provide emerging drug safety information that could potentially alter the benefit/risk analysis for a drug, and therefore, affect a doctor's decision to prescribe it, or a patient's decision to take it. Examples of drug safety information that would be communicated include:

  • Serious adverse drug experiences identified after approval or in the setting of a new use;
  • Additional serious or more frequent adverse drug experiences in a subpopulation of patients; and
  • Medication errors.

?All drugs have risks, and health care professionals and patients must balance the risks and benefits of a drug when making decisions about drug therapy,? according to the guidance. After a new drug is approved, the FDA reviews the data and evaluates potential safety concern. If there is a safety issue, FDA scientists immediately review and analyze data. The problem is the period of uncertainty during the period of evaluation.

In 2004, Merck voluntarily recalled Vioxx, a pain medication, after problems surfaced showing that the drug increased the risk of heart attack and stroke among people who took it for at least 18 months. The FDA received harsh criticisms for its slow reaction to signs of problems with Vioxx and the scarcity of reliable information about such problems.

In light of Vioxx, the FDA initially planned to establish a new Web site to be called Drug Watch, which will serve as an early-warning system for adverse events. However, pharmaceutical companies feared that people will confuse Drug Watch with MedWatch, the FDA's safety information and adverse-event reporting program that allows health-care professionals and the public to report serious problems associated with medical products. The industry was also concerned that any premature information would scare patients.

Consequently, the FDA has abandoned its plan to launch Drug Watch. Instead, it will utilize the existing ?Index to Drug-Specific Information? section of the FDA's Web site for communication about serious side effects. The FDA will put a red asterisk next to names of medicines with any emerging safety information. A patient or a health-care provider can then click on the drug name to get to links to FDA advisories and other information.

Under the new guidance, the agency will also use the following to communicate drug safety information to the public:

  • Labeling (including patient package inserts and medication guides)
  • Public health advisories
  • Patient information sheets
  • Health care professional sheets
  • Alert on patient information and health care professional sheets

Consumer advocates, such as the Public Citizen's Health Research Group, are unhappy about the FDA's decision to abandon the plan for Drug Watch. But the Pharmaceutical Research and Manufacturers of America (PhRMA) supported the FDA's initiative. ?It is crucial for FDA's drug safety alerts to strike a proper balance between protecting safety through the timely dissemination of information and promoting public health by ensuring continued access to potentially life-saving medicines,? said Alan Goldhammer, PhRMA deputy vice president for regulatory affairs.

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FDA Links

  • FDA?s Drug Safety Guidance
    Link

  • Index to Drug-Specific Information
    Link

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