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Understanding the FDA’s drug approval process

| Sep 11, 2020 | Biotech & Pharmaceuticals |

The current coronavirus pandemic has stirred much conversation and speculation about a possible vaccine or a therapeutic medication. Most people involved in these conversations are aware that the United States Food & Drug Administration must approve a drug before it can be lawfully prescribed or sold, but very few people understand just how the FDA conducts its review and approval of a new drug. The process is relatively uniform, and its fundamental aspects are not difficult to grasp.

Seeking approval

According to the Food & Drug Act, no drug can be sold in the United States unless it has been judged to be “safe and effective” by the Food and Drug Administration. Any company seeking permission to sell a drug in the United States must first test the drug to determine if it provides effective treatment for the illness or condition that it is intended to treat. The manufacturer must also conduct tests to determine if the drug is safe, that is, that it does not cause harmful side effects that outweigh its benefits.

After the manufacturer has completed its testing, the data is submitted to the FDA where the information is reviewed by the Center for Drug Evaluation and Research (CDER). The review is conducted by a team of physicians, statisticians, chemists, pharmacologists and other scientists review the manufacturer’s data and proposed labeling. If this review demonstrates that the drug is both safe and effective, it is approved for sale in the United States.

In deciding whether to approve a drug as safe and effective, the FDA also considers the label information that the manufacturer must provide. This information includes both labels placed on the medicine’s container and the information on the brochure included in the drug’s packaging, known as the “package insert.” The agency’s timeline for approval has a number of special situations, depending upon the need for the drug and the availability of other treatments.

A lawyer’s assistance can help

Anyone interested in submitting a drug to the FDA for approval may wish to consult an attorney with FDA experience. A knowledgeable attorney can advise an applicant on the available shortcuts and the likelihood of final approval.