The Food and Drug Administration (FDA) is responsible for the safety and effectiveness of drugs sold in the United States. The process to get the FDA’s approval for a pharmaceutical product is usually very long and complicated.
The FDA’s Center for Drug Evaluation and Research (CDER) conducts research to test the drugs’ quality, but the pharmaceutical companies that aim at introducing a new product on the US market are responsible for extensive testing of the drugs to prove they’re safe and effective. The CDER then reviews the data included in the new drug application (NDA). After the development phase, the FDA goes though preclinical and clinical research, review, and post-market safety monitoring.
Experts in this field rarely share their advice on how to deal with the FDA in the most effective way and how to be successful in the pharmaceutical business. “Mastering the art of communication and being proficient in marketing techniques can be helpful,” told us Alessandro Ricci, president of the US branch of the Chinese big pharma company Aurisco. “You have to discover a product’s potential, develop a plan, and clearly describe the assets and advantages a drug can bring to the American market and the world in general,” explained the Italian CEO, product developer and expert of the life-cycle management associated with the supply chain. Having a nice dose of charm, being personable, and able to put people at ease are other important qualities to develop.
Mr. Ricci is responsible for the success of very popular drugs and active substances, such as the extremely popular steroid medicine Fluticasone Propionate, generic of Advair. Sold today under the brand names Flovent and Flonase among others, this product 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. “I make the technical aspects very simple for clients and supervise the document filing for drugs to be successful with the FDA’s approval,” the 43-year-old entrepreneur added.
Mr. Ricci is also the mind behind 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.
Mr. Ricci’s knowledge of the US marketing and business world has been a crucial asset for many international companies in America. Probably his most important piece of advice is inspired to professional sports and the athlete’s mentality, which he gets from his passion for marathon running: “Be persistent. Just like athletes must train every day in order to be able to finish a marathon, you should fight every day to get to your short-term goals,” he explained. “Working in this field is just like a long-distance race: You need to fight every mile to get to the finish line.”