Drug Approval Process

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Researchers at Yale School of Medicine reported in a May 2017 JAMA article that 71 out of 222 drugs approved from 2000 to 2010 were withdrawn, required a black box warning on side effects or warranted a safety announcement about new risks. The same report also found that “drugs approved in under 200 days were less likely to have safety issues which they speculated was due to some approval packages providing clear evidence of safety.” On average, a new medicine can take ten years and cost $2.6 billion to bring to market. The cost and risk associated with drug development is critical to the pharmaceutical company’s success. Do you understand the FDA drug approval process? Here it is simplified by the FDA itself.

Step 1: Discovery and Development

Lab and animal testing of new molecular compounds and novel ways of targeting medical products to sites in the body. Discovery and development can work on dosage, administration, side effects, demographic variances, absorption, excretion, drug interactions and effectiveness versus similar compounds.

Step 2: Preclinical Research

This can be in vitro (outside of a living organism) or in vivo (in a living organism.) The main goal is to analyze toxicity.

Step 3: Clinical Research

Phase 1: 20-100 volunteers and lasts several months. Targeting safety and dosage questions. 70% of these drugs move on to the next phase of the drug approval process..
Phase 2: Several hundred volunteers who have the disease and lasts from a few months to two years. Targeting the efficacy of the drug and its side effects. 30% of drugs move on from here to the next phase of the drug approval process.
Phase 3: 300-3000 volunteers and can last up to four years. Monitor the efficacy across a wider demographic cohort and exploring long-term adverse reactions. 25-30% move on to the last phase of the drug approval process.
Phase 4: Several thousand volunteers with the disease continuing to monitor safety and efficacy.

Step 4: FDA Review

Once the FDA’s Center for Drug Evaluation and Research (CDER) has received a New Drug Application (NDA) detailing all of the results from the lab, animal and four phases of clinical trials they have 60 days to accept the application. Missing data will get the application refused. CDER then acts within 10 months of receiving the application or six months with priority drugs. Of course, they may request further data before making a final decision. If approved, the FDA then works with the applicant to develop prescribing information and moving on to Step 5.

Step 5: FDA Post-Market Safety Monitoring

The FDA reviews the drug’s advertising, manufacturing and ongoing safety and side effect results while drug is in the marketplace.

Time to Market

The biggest complaint about new drug development is the time it takes for a drug to get to market. The FDA has put in four methods to speed-up their drug approval process: Fast Track (for drugs that fill an unmet medical need), Breakthrough Therapy (drugs that are substantially more effective), Accelerated Approval (drugs that fill an unmet need and have evidence of potential benefit) and Priority Review (the FDA states a goal of making a decision in six months.) As admirable as these efforts are for faster FDA approval the real time commitment is in the development and clinical trial phase. Speeding up that area could mean vastly more safety issues. “All too often, patients and clinicians mistakenly view FDA approval as indication that a product is fully safe and effective,” Says Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”

Want to be a part of the industry trying to cure our medical ills? Contact Smith Hanley Associates’ Pharmaceutical Sales Recruiter, Nancy Ragonese, at [email protected].


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