The FDA’s Drug Approval Process – Part 1 of a 3-part series

Guest post by Christie Bell, CLP

As the global race to find a vaccine for COVID-19 (novel coronavirus) speeds up by the hour, biotech companies with a potential solution to the pandemic, but who aren’t familiar with the Food and Drug Administration (FDA) approval process, are feverishly seeking primer-level information and guidance. Over the past few years, the FDA has streamlined and simplified the process to move drugs from concept to the pharmacy shelves, while maintaining the stringency required to keep Americans safe; it’s a tall order, to say the least.

The watchdog system that governs the evaluation of new drugs is the Center for Drug Evaluation and Research (CDER). The center ensures that pharmaceuticals work as intended and that their proven benefits outweigh the known risks.

All drug companies interested in developing a drug for the United States commercial marketplace must first test it and prepare a product label. The results and draft label are then sent to CDER for an independent review by the Department’s physicians, statisticians, chemists, pharmacologists, and other scientists. If this unbiased review shows that the benefits do, indeed, outweigh the potential risks, then the drug is approved for sale. The center doesn’t perform testing, but does conduct research on quality, safety, and effectiveness.

The applicant company for new drug approval is known in CDER language as the “sponsor.” The sponsor’s internal strategy begins with laboratory and animal testing, then moves to human trials to validate the claims that the medicine is safe and successful in treating the targeted disease and provides a real health benefit.

The drug approval process takes place within a carefully structured framework that includes analysis of the target condition; available treatment; assessment of benefits and risks from clinical data; and strategies for managing the known risks. As a rigorously diligent scientific organization, the FDA uses the foremost scientific and technological information to make decisions on drug approval. However, the Administration doesn’t always agree with the sponsor’s findings, despite the firm’s equally valid testing and analysis methods.

Depending on the significant benefits of the proposed drug promises, the application for approval is slated for one of four different tracks. The Fast Track process develops and facilitates the review of drugs that treat serious conditions which, currently, fill an unmet medical need such as a cure for dementia. The Breakthrough Therapy track allows the sponsor to demonstrate that their compound offers a substantial improvement over currently available drug therapies. For example, atrial fibrillation was treated with warfarin for decades, but now is slowly being replaced with shorter-acting medications that don’t require regular blood tests or dietary changes. The Accelerated Approval track means the application process can be expedited, which is particularly useful if the proposed drug is meant to treat a long-term disease, and an extended period of time is needed to accurately measure its effect. If the drug is approved on this track, the sponsor is then required to conduct post-marketing clinical trials to prove and describe the drug’s benefit. Lastly, to receive the Priority Review designation means the FDA aims to offer direct attention to a proposal within six months, compared to the standard 10-month timeline. Such is undoubtedly the case with potential COVID-19 vaccines.

The next article in this series will provide information on the first steps companies need to take to advance their innovations from the in-house laboratory and into the FDA approval system.

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