Prescription Drugs, Products Liability, and Preemption of Tort Litigation
- Catherine D. DeAngelis, MD, MPH;
- Phil B. Fontanarosa, MD, MBA
- Author Affiliations: Dr DeAngelis is Editor in Chief and Dr Fontanarosa (phil.fontanarosa@jama-archives.org) is Executive Deputy Editor, JAMA.
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- BIOLOGICAL PRODUCTS
- DRUG INDUSTRY
- DRUG REACTION, ADVERSE
- DRUG AND NARCOTIC CONTROL
- DRUG APPROVAL
- EQUIPMENT AND SUPPLIES
- JURISPRUDENCE
- LIABILITY, LEGAL
- PATIENT SAFETY
- PRESCRIPTIONS, DRUG
- UNITED STATES FOOD AND DRUG ADMINISTRATION
The benefits and risks associated with pharmaceutical agents and medical devices have received increasing attention from the medical community, the public, and government agencies. Serious concerns about US Food and Drug Administration (FDA) capabilities and oversight for ensuring accurate determination of safety and efficacy, appropriate mechanisms and decisions regarding drug and device approval, and effective postmarketing surveillance have prompted investigations by the Institute of Medicine1 and by an FDA blue ribbon commission.2 Major legislation3 has been enacted to improve the agency's ability to fulfill the daunting responsibility of ensuring that pharmaceutical products and medical devices approved for marketing are safe.4
Even though the evaluation of new drugs and devices is technically rigorous, the current approach of basing drug approval decisions on clinical trials of efficacy that include relatively small numbers of patients virtually guarantees that the full risks and complete safety profile of these drugs will …
