Before a prescription drug reaches your medicine cabinet, it goes through a rigorous, multi-step approval process overseen by the U.S. Food and Drug Administration (FDA). This process is designed to evaluate whether a drug is safe and effective for public use. However, even after a drug like Dupixent clears every regulatory hurdle and earns FDA approval, adverse effects can still emerge after it has already been widely prescribed.
The Four Phases of the FDA Drug Approval Process
The FDA’s Center for Drug Evaluation and Research (CDER) oversees drug approval using an independent team of clinicians and scientists. Before a drug ever reaches the market, it must pass through four distinct phases:
- Phase 1 – Safety: A small group of healthy volunteers participates in studies lasting about one year. Researchers focus on establishing the drug’s safety profile, identifying side effects, and examining how the body absorbs, metabolizes, and excretes the drug.
- Phase 2 – Effectiveness: A larger group of patient volunteers with a specific condition is studied over approximately two years. Some participants receive the actual drug while others may receive a placebo, allowing researchers to assess whether the drug works as intended.
- Phase 3 – Expanded Testing: If Phase 2 is successful, trials expand to include several hundred to thousands of patients across clinics and hospitals over roughly three years. Researchers evaluate effectiveness across different patient populations, age groups, and dosages while watching for additional side effects.
- Phase 4 – Post-Marketing Surveillance: After approval, Phase 4 studies gather real-world data on safety, efficacy, and optimal use. This is a critical stage because rare side effects are unlikely to surface in earlier, smaller trials.
How Long Does It Take for a Drug to Be Approved?
The research, development, and approval timeline can span 12 to 15 years. It begins with preclinical research, where a manufacturer synthesizes and screens drug candidates for toxicity in animals. If a compound shows promise, the sponsor files an Investigational New Drug (IND) Application with the FDA. The FDA reviews this application to confirm that clinical trials will be safe for human participants.
From there, human studies begin under the oversight of both the FDA and a local institutional review board. Once a drug is approved, post-marketing review continues through Phase 4 studies and the FDA’s MedWatch program, which monitors side effects reported by patients and healthcare providers.
What Happens If a Drug Shows Adverse Effects After FDA Approval?
Even with years of testing, some problems only surface when a drug is used by a large, diverse population. That’s why the FDA requires companies with approved drugs to submit post-marketing safety information. The FDA reviews this data, conducts inspections to evaluate compliance, and assesses risks to patients.
An adverse event is any unexpected experience or side effect associated with a drug’s use, whether from normal use, overdose, abuse, withdrawal, or a lack of expected effectiveness. If companies fail to comply with reporting requirements, the FDA can take enforcement action.
Filing a Dupixent Cutaneous T-Cell Lymphoma Lawsuit
Lawsuits are now being filed on behalf of individuals who developed cutaneous T-cell lymphoma (CTCL) after using Dupixent. These cases allege that the drug’s manufacturer failed to adequately warn patients and healthcare providers about the risk of this serious condition. If you’ve been diagnosed with CTCL after taking Dupixent, you may be eligible to pursue a claim. Shapiro Legal Group, PLLC can evaluate your situation and guide you through your legal options. Contact us today at (800) 220-0984 to discuss your case.