The Right To Unapproved Medicines
A U.S. appeals court recently ruled that “terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators”.
The process by which U.S. Food and Drug Administration (FDA) approves a new drug can usually take about 10 years and the process includes animal and laboratory tests (preclinical testing) which could advance to clinical trials with people, if proven safe. Most drugs, however, do not make it even to clinical trials and review by FDA.
To have an idea of how long and rigorous the process is, take a look at this summary review of the steps that new drugs usually undergo before FDA approval:
- Preclinical (animal) testing. Pre-IND (Investigational New Drug Application)
- An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
- Phase 1 studies (typically involve 20 to 80 people).
- Phase 2 studies (typically involve a few dozen to about 300 people).
- Phase 3 studies (typically involve several hundred to about 3,000 people).
- The pre-NDA (pre-New Drug Application) period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
- Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
- After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
- If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.
- The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug).
- The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
- FDA reviewers will approve the application or find it either “approvable” or “not approvable.”
According to Reuters Health, two advocacy groups, The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation, have sued FDA, seeking greater access for dying patients to unapproved medicines that have cleared early safety tests, which usually include 20 to 80 people or the Phase 1 testing. They argued that patients have every constitutional right to try experimental drugs, if they so choose.
