FDA Drug Approval: What The Process Looks Like

Laws, Medical Records

The initial phases of development, called pre-clinical testing, take place in the pharmaceutical laboratory where in vitro experiments are conducted between the new drug and the disease to see if there is any reaction. During these experiments the research is concerned with safety, toxicity and biological activity and the experiments are limited to animal and laboratory studies. This period alone, for a single compound, can take on average three to four years to complete and typically 5,000 compounds are evaluated at a given time. Once the pre-clinical testing is finished, the company will file an investigational new drug application (IND) with the FDA.

Once the IND application is approved, clinical testing can begin on humans. There are three stages to clinical testing called Phase I, Phase II, and Phase III. Phase I involves twenty to eighty healthy volunteers and the goals are to determine safety and toxicity of the compound, it’s in vivo behavior, and preliminary dosage requirements or potential indications for the drug. Phase II consists of 100–300 volunteers who are afflicted with the disease being researched and the potential compound to combat it. This phase lasts around two years and the goal is to determine effectiveness and side effects of the compound. Typically, only five of the original 5,000 compounds will enter Phase II. Phase III involves controlled experiments with 1,000–3,000 volunteers whom physicians monitor during the trial period. At this stage, which lasts about three years, the goal is to verify effectiveness and monitor effects of long-term use. Here dosage is refined and adverse reactions can be further monitored. Typically the studies are controlled, following a form of randomized double-blind, placebo-controlled investigation so that neither the investigator nor the patient knows who is taking a placebo.

After the clinical-testing phase is over the company submits a new drug application (NDA) to the FDA, which includes the data and analyses of safety and efficacy of the compound from the phases of clinical investigation. The FDA review phase is performed by three of the six FDA centers consisting of physicians, pharmacologists, chemists, microbiologists, and statisticians. In addition to FDA reviewers there are also advisory committees making decisions with regards to the compounds.

FDA review is followed by Phase IV, which consists of post-marketing testing where the FDA will use adverse reactions reported in the public to educate physicians, pharmacists, and patients when safety concerns arise by: (1) “Dear Healthcare Professional” letters which provide product safety information to the aforementioned individuals, (2) the pharmaceutical company may be required to alert consumers with brochures and advertising themselves, (3) the pharmaceutical company may have to change labeling on the product and restrict the use of the drug further or (4) the company may need to withdraw the product entirely from the market.

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