$2.6 billion! That’s how much Tuft’s University research says it costs to bring a new drug from the research lab to the pharmacy counter. The full research, development and approval process can last from 12 to 15 years.
The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) is a science-led organization in charge of overseeing the drug approval process before a drug is marketed. CDER ensures that both brand and generic drugs work correctly and that the health benefits outweigh the known risks.
In the manufacturer’s early phases of drug discovery (preclinical research) they are synthesizing and screening a drug candidate for toxicity in animals before the medicine moves on to human trials. The sponsor files an Investigational New Drug (IND) Application that details specifics such as chemistry, manufacturing and the initial plans for human testing.
A drug then undergoes several years of laboratory testing before a New Drug Application (NDA) is made to the FDA to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.
If the FDA gives the green light, the investigational drug will then enter three phases of human clinical trials:
— Phase 1: About 20 to 80 healthy volunteers to establish a drug’s safety and profile, and takes about 1 year.
— Phase 2: Roughly 100 to 300 patient volunteers to assess the drug’s effectiveness in those with a specific condition or disease. This phase runs about 2 years.
— Phase 3: Typically, several thousand patients are monitored in clinics and hospitals to carefully determine effectiveness and identify further side effects.This phase runs about about 3 years on average.
For an NDA, the company writes and submits an application which includes thousands of pages to the FDA for review and approval. The NDA is the official request for US approval of a drug. The FDA team has 60 days to review the NDA and determine if it will be filed for further review.
A group of independent physicians and other clinicians, called an FDA Advisory Board, meets to discuss the NDA with the FDA reviewers and manufacturer of the product. These meetings often take one or two days. After the meeting, the Advisory Board will make a recommendation for approval, or not, to the FDA, usually through a vote. The FDA often follows the advice of the Board, but is not obligated to do so.
After final approval, the drug becomes available for physicians to prescribe. However, drugs may not come to the market immediately because of patents disputes, manufacturing issues, or controlled substance designation from the DEA.