The FDA’s drug approval process: Expert’s advice on how to make it smoother

The Center for Drug Evaluation and Research (CDER), part of the Food and Drug Administration (FDA), ensures that drugs sold in the US are effective and safe.  Although it doesn’t test the drugs, the CDER’s Office of Testing and Research is responsible for conducting limited research in the areas of drug effectiveness, quality, and safety.

It is the responsibility of the company seeking to submit a new drug application (NDA) to introduce a new product into the American market to test the drug and prove it is safe and effective.  The CDER’s team of pharmacologists, physicians, chemists, statisticians, and scientists reviews the company’s NDA containing all the data and proposed labeling.  The FDA drug approval process is divided in five phases: discovery/development, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring.

Getting the FDA’s approval might be particularly difficult and cumbersome. Created 30 years ago, the FDA’s review process called “accelerated approval” allows pharmaceutical companies to license potentially-game changing treatments using a “surrogate marker” of effectiveness. For instance, evidence of shrinking tumors could be enough to get an approval for oncologic drugs.  

In the past few years, the accelerated process has become very common: i.e., 14 out of 50 approvals of new drugs in 2021 compared with four of the 59 drugs licensed in 2018.  Besides the controversial “fast track”, are there any communication and marketing tips to make the process easier and the approval more likely? Are there any secrets to be successful in the pharmaceutical world?“

You have to perfect the art of describing the qualities and potential of a product, in order to get appreciation,” said Alessandro Ricci, president of the American branch of the Shanghai-based pharma giant Aurisco.  “Excelling in communications and marketing techniques is crucial,” explains the 43-year- old CEO, product developer and expert of the life-cycle management associated with the supply chain.

 Mr. Ricci is the mastermind behind the development and the FDA’s approval of very well-known drugs and active substances, such as the extremely well-known steroid medicine Fluticasone Propionate, generic of Advair.  Sold today under the brand names Flovent and Flonase among others, Fluticasone Propionate works by decreasing inflammation and is used for the long-term management of asthma, but also to treat hay fever, nasal polyps, and mouth ulcers.  With over 24 million prescriptions, Fluticasone was the 23rd most prescribed medication in the United States in 2020.

 A tip from Mr. Ricci is “put people at ease”.  The Italian entrepreneur, responsible for the success of many international pharmaceutical companies in the United States, says his biggest talent is to “make people laugh”.

Among Mr. Ricci’s other accomplishments, the development of the Active Pharmaceutical Ingredient (API) Fulvestrant, used in the generic oncologic drug Faslodex and of Abiraterone acetate, a medication used to treat prostate cancer, sold under the brand name Zytiga among others.  Today’s consumer “wants products of excellence, whose superior perceived quality is due to technical-functional characteristics as well as innovative content,” Mr. Ricci explains.   

Appreciated in the business world for his talent in understanding a drug’s potential and describing how the products he represents can be a very useful asset for the American pharmaceutical world, Mr. Ricci has another piece of advice: “Be persistent and don’t get discouraged”.  

From his big passion for marathon running, the Big Pharma CEO learned the pharmaceutical business can be compared to a marathon. His inspiring message is: “Fight and win every mile, to get to the finish line”. 

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