POSTMARKETING STUDIES

To advocate that Congress grant the Food and Drug Administration (FDA) authority to require the manufacturer of an approved drug product or licensed biologic product to conduct postmarketing studies on the safety of the product when the agency deems it to be in the public interest and to require additional labeling or withdrawal of the product on the basis of a review of postmarketing studies; further,

To advocate that Congress provide adequate funding to FDA and other agencies to fulfill this expanded mission related to postmarketing surveillance and studies; further,

To advocate that such studies compare a particular approved drug product or licensed biologic product with (as appropriate) other approved drug products, licensed biologic products, medical devices, or procedures used to treat specific diseases; further,

To advocate expansion of studies of approved drug products or licensed biologic products to improve safety and therapeutic outcomes and promote cost-effective use; further,

To encourage impartial public-private partnerships or private-sector entities to also conduct such studies.

Rationale

Pharmacists, other members of the healthcare team, patients, and private and public payers need objective, authoritative, and reliable evidence to make the best treatment decisions. Since the passage of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, the Agency for Healthcare Research and Quality (AHRQ) has been tasked with studying the outcomes, comparative clinical effectiveness, and appropriateness of healthcare items and services. For such research to contribute to the practice of evidence-based patient care, good clinical decision-making, and rational drug use, AHRQ must evaluate devices, invasive procedures, and prescription and nonprescription medications, including both labeled and unlabeled uses of prescription drugs. Since prescription drugs represent a significant and growing portion of healthcare costs, the need for such research is increasingly important. Although impartial private sector entities can supplement the research efforts of government agencies such as AHRQ, only the federal government has the ability to support such independent research, provide oversight to safeguard the integrity of the research process, and disseminate the findings.

Furthermore, to ensure safety, the Food and Drug Administration (FDA) has several requirements for manufacturers and programs in place to monitor postmarket adverse events. These requirements and programs include the Division of Medication Error Prevention and Analysis, which is responsible for monitoring and preventing medication errors related to the naming, labeling, packaging, and design for CDER-regulated drugs and therapeutic biological products; the Risk Evaluation and Mitigation Strategy (REMS) program, which is designed to help reduce the occurrence and severity of certain serious risks; by informing and supporting the execution of the safe use conditions described in the medication's FDA-approved prescribing information; the Safe Use Initiative, a program that aims reduce preventable harm by identifying specific, preventable medication risks and developing, implementing, and evaluating cross-sector interventions with partners who are committed to safe medication use. Other programs include the FDA Adverse Event Reporting System (FAERS), which is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events that were submitted to FDA, and MedWatch, the FDA Safety Information and Adverse Event Reporting Program, which permits voluntary reporting by consumers and healthcare professionals and mandatory reporting for regulated industry and user facilities. Additionally, the FDA requires that adverse drug events (ADEs) must be reported in accordance with the requirements of 21 CFR 310.305 and 314.80, which require three types of ADE reports: (1) 15-day reports of serious, unlabeled events; (2) 15-day narrative increased frequency reports of serious, labeled events; and (3) periodic reports.