CAMLAW: Complementary and Alternative Medicine Law Blog

FDA Attacks Continue

FDA attacks continue unabated over failure to adequately measure drug risks prior to new drug approval.

Criticism of the FDA has been widely reported as of late.

"Today, the Star Ledger joined FDA critics when it released an article claiming that the FDA 'fails to measure drug risks.' The article criticized the FDA's current approach to monitoring drugs, which relies upon drug manufacturers to report serious adverse events to the FDA within 15 days of learning about the events....Though the Institute of Medicine called for stronger enforcement powers for the FDA, new labeling requirements, advertising limits and further clinical trials after market approval, it still seems as though there is still no clear plan of action to address the FDA's deficiencies."

This is from health law attorney's Attorney Jayne E. Juvan Health Law Update, which contains helpful recaps of news such as "Pharmaceutical Companies Face Decreased Earnings As Generics Enter the Market" and "Modern Healthcare/AP Report Frightening Data Loss by Indiana Hospital."
The FDA has been criticized for a while now: see

* FDA Advisory Panels Biased Toward Drug Approvals.

* FDA Less Trusted

See also:

FDA Warns Manufacter of Drugs Claims in Herbal Formula

Are Drugs More Dangerous than Supplements?

FDA Announces Major Initiatives for Dietary Supplements

Meanwhile, in Protecting the Health of the Public -- Institute of Medicine Recommendations on Drug Safety, the New England Journal of Medicine notes problems with the regulatory system of drug approval:

Under the current model, drugs are rapidly evaluated before approval and are often aggressively marketed afterward. Direct-to-consumer advertising can rapidly expand the use of new drugs to include patient groups that were sparsely represented in pre-marketing evaluations. The centerpiece of the CDER post-approval safety system is the Adverse Event Reporting System (AERS); in this system, patients or health care professionals submit reports of adverse events thought to be related to drug administration. Although this collection of voluntarily submitted case reports represents the weakest form of epidemiologic evidence, many drugs have been appropriately relabeled, sometimes with black-box warnings, or withdrawn from the market on the basis of AERS evidence.

CDER lacks a systematic approach to identifying possible pre-marketing drug-safety problems and translating them into high-quality post-marketing studies. Without an organized system to identify potential safety signals, the studies needed to resolve them may not be performed. The post-marketing commitments that are requested by the FDA are often hastily assembled by sponsors, who may not have a symmetric interest in safety and efficacy. Even so, once a drug is approved, CDER lacks the authority to force sponsors to complete agreed-upon post-marketing commitments or to require sponsors to initiate new studies. As a result, hundreds of agreed-upon studies remain "pending" in perpetuity. Since CDER lacks the resources to conduct its own studies, when a new drug is launched, the current regulatory system creates "an evidence-free zone."

The NEJM quotes the Institute of Medicine report for a 'new vision of drug safety' as follows:

The increasingly complex interface between innovation and regulation has been characterized by binary opposites: speed versus safety, tight preapproval regulation versus loose postapproval regulation, active collection of data before approval versus passive surveillance after approval, and an abundance of clinical efficacy data before approval compared with much less safety data after approval. The polarity of approach and emphasis is inconsistent with the widely accepted notions that risk must be considered in the context of benefits, that understanding of the risks and benefits associated with a drug changes over a drug's lifecycle, and that the attention paid to safety and efficacy before approval must therefore be sustained as a drug enters and diffuses through the market and is used by a growing number and diversity of patients. Timely approval and attention to safety can become complementary rather than antithetical goals as postapproval surveillance becomes more effective, and regulatory authority and its exercise are commensurate with how a drug performs in real-life conditions over its lifecycle.

The approval decision does not represent a singular moment of clarity about the risks and benefits associated with a drug -- preapproval clinical trials do not obviate continuing formal evaluations after approval. However, the approval decision is a critical juncture in a product's lifecycle because it releases a drug to the market, where the public will gain broad exposure to it. In a strengthened drug safety system, that juncture should mark the beginning of another important stage in the lifecycle, when regulators, sponsors, health insurers, health care providers, and independent researchers actively pursue and manage emerging knowledge about risk-benefit relationships and uncertainty and they communicate that knowledge to patients, health care providers, and health care organizations in a timely manner.

-- Excerpt from "The Future of Drug Safety: Promoting and Protecting the Health of the Public"

Committee on the Assessment of the US Drug Safety System, Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2006.

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Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173