The Food and Drug Administration (FDA), as many are aware, is the leading entity for the regulation and safety testing for foods and pharmaceuticals in the country. Research is essential in deciding about the future of new drugs and regulating the market. The Center for Drug Evaluation and Research (CDER), which is part of the 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.
Before introducing a new product into the American market, it must be submitted to test to prove it is safe and effective. The company introducing the drug must submit a new drug application (NDA). The CDER’s team of pharmacologists, physicians, chemists, statisticians, and scientists reviews the company’s NDA containing all the data and proposed labeling.
Currently, the FDA drug approval process is divided in five phases: discovery/development, pre-clinical research, clinical research, FDA review, and FDA post-market safety monitoring.
Getting the FDA’s approval might take many years, but the FDA’s review process called “accelerated approval” allows pharmaceutical companies to license potentially game-changing treatments using a “surrogate marker” of effectiveness.
In the past few years, the accelerated process has become very common, although controversial. Are there any other ways or techniques to make the approval process easier?
“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.
Alessandro Ricci, product developer and expert of the life-cycle management associated with the supply chain in the Big Pharma world, is responsible for the development and the FDA’s. approval of popular drugs, such as the well-known medicine for respiratory issues Fluticasone Propionate. 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.
The Italian entrepreneur, responsible for the success of a number of international pharmaceutical companies in the United States, says his biggest talent is to “make people laugh”.
Among Mr. Ricci’s 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.
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”. Determination, tenacity, and dedication are key in this business.