top Importance and impact of new medicines’ approvals on healthcare

There is no denying the role and importance of drugs and medicines in our lives. According to data, nearly forty-eight percent of people in the United States were reported to be using at least one prescription drug in the last thirty days in the United States with more than sixty-eight percent of visits to a physician’s office involving some form of drug therapy. Although there is no comparable data available for India, that medicines constitute the single largest component of out-of-pocket expenditure of Indian households illustrates the role and value of medicines in our lives. If regular prescription drugs or over-the-counter medicines hold such enormous value in everyday health-related affairs, imagine and consider the importance and impact of newly-approved medicines for individual patients and families who would desperately need them as well as health authorities for whom every persisting disease is a challenge and every new cure would be the proverbial light at the end of the tunnel. While the same drug if repurposed is approved again to treat a new disease or a new population of patients or patient cohort, typically the launch of a newly approved drug implies that the latest innovation in question is the best treatment available anywhere in the world for a given medical condition at a given point in time. For instance, until the last decade, diseases such as hepatitis B and C were sought to be addressed only with curative intent hoping to extend the lifespan of a patient and not really help the patient get rid of the disease permanently. But in 2015, with the emergence of new medicines on the market, hepatitis was transformed from a barely manageable condition to one that could be safely and easily cured by all-oral treatment options. In a similar vein, new advances in treatment of breast cancer make sure that the unlike ten-fifteen years ago when a survivor lived on for four to five years maximum, today, he or she can enjoy an extended lifespan of twenty to twenty five years post-treatment. In recent years, the number of new approvals has been on a constant rise. To illustrate, in 2020, the US FDA’s Centre for Drug Evaluation and Research (CDER) approved 53 novel drugs, the second highest count in over 20 years, marginally lower than 2018’s 59 approvals. The diseases covered by newly approved drugs had covered a wide spectrum ranging from infectious diseases such as Covid-19, HIV, chronic hepatitis C and flu prevention including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, to neurological conditions such as Parkinson’s disease and spinal muscular atrophy (SMA). Incidentally, this was the first orally administered drug approved for SMA. In addition, the US also saw the first FDA-approved therapy to treat the rare disease lupus nephritis apart from new approvals for cancers such as thyroid cancer and lung cancer. Undoubtedly, most of these diseases and disorders have a global footprint impacting populations across the world. For its part, India had approved 26 new drugs in 2019, 29 in 2020 and 26 in 2021, nearly half of what has been approved on an average in the US.