Drug Reporting and Recalls

The Food and Drug Administration (FDA) is a United States science-based law enforcement agency mandated to protect public health and safety and is governed by federal law under the FDA Modernization Act (FDAMA) of 1997. The FDA is responsible for ensuring that the following products are safe and effective:

• Medicines
• Medical devices
• Blood products
• Vaccines
• Cosmetics
• Veterinary drugs
• Animal feed
• Electronic products that emit radiation

FDA's Center for Drug Evaluation and Research

The FDA's Center for Drug Evaluation and Research (CDER) ensures that drugs are safe and effective. While the CDER does not test drugs, it does conduct limited research in the areas of drug quality, safety, and effectiveness. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's new drug application (NDA) containing the data and proposed labeling.

FDAMA Provisions

Provisions of the FDAMA include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods. Products regulated by the FDA include:

• All foods except for meat and poultry (regulated by the US Department of Agriculture (USDA))
• Prescription and non-prescription drugs
• Blood products
• Vaccines
• Tissues for transplantation
• Medical devices and radiological products, including cellular telephones
• Animal drugs and feed
• cosmetics

Problem and Issue Reporting

Timely reporting of problems and issues related to drugs and medical devices by all stakeholders allows the FDA to take appropriate action. The FDA evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

MedWatch Online Voluntary Reporting Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of serious adverse events, potential and actual product use errors, and product quality problems associated with the use of FDA-regulated drugs, biologics, medical devices, special nutritional products, and cosmetics. Events involving vaccines should be reported to the Vaccine Adverse Event Reporting System (VAERS)

User-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both the FDA and the manufacturer, if known, and serious injuries to the manufacturer or to the FDA, if the manufacturer is unknown. These reports must be made on the MedWatch 3500A Mandatory Reporting Form. Adverse events involving investigational (study) drugs, such as those relating to Investigational New Drug (IND) applications should be reported as required in the study protocol.

Recall Procedures

The manufacturers or distributors of a product carry out most recalls of products regulated by the FDA voluntarily. In others, the FDA informs a company of findings that one of its products is defective and suggests or requests a recall. If the company does not voluntarily recall the product, then the FDA can seek legal action under the Federal Food, Drug, and Cosmetic Act including requesting a seizure of available product or an injunction requiring recall of the product.

FDA guidelines for companies to follow when recalling defective products under FDA jurisdiction are published in Title 21 of the Code of Federal Regulations, Part 7. These guidelines make clear that the FDA expects these companies to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify the FDA when recalls are started, to make progress reports to the FDA on recalls, and to undertake recalls when asked to do so by the FDA.

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