At anytime, there are more than 300,000 clinical studies happening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector to protect public safety. The stringency of this regulation is evidenced by the fact that since the Food and Drug Administration (FDA) came into being in 1938, just 1,453 drugs have been approved, despite 7.3 million drugs being reviewed during clinical development.
The FDA has long been criticized for taking too long to approve new drugs so Congress passed legislation in the 90’s aimed at speeding up the entire process. In 2004, Merck withdrew its painkiller Vioxx after studies showed the pill increased the risk of heart attacks and strokes. In this instance the FDA was highly criticized for approving medicines too easily and for delaying issuing warnings about potential drug risks. Congress attempted to amend this, so in 2016 the 21st Century Cures Act was passed. The entire process took three years for Congress to pass it and its benefits have yet to be fully seen (statnews).
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In order to achieve future growth the FDA could look to India as an example. The current rate of seven to eight percent CAGR growth is expected to lead to about $80bn to $90bn in sales by 2030. According to the Indian Pharmaceutical Association, simplifying regulatory approval processes is key for the sector to experience growth.
Technology is key for moving these regularity processes forward. Organizations such as the Regulatory Affairs Professionals Society (RAPS) explores the challenges and opportunities for the regulatory affairs sector of implementing digital health solutions, data safety and data risk in the digital healthcare sector and global digital drug information sources. TORPA: The Organization for Professionals in Regulatory Affairs also highlights how future talent in the industry will need to embrace new skills, such as data analytics, to improve the regulatory process in line with technological innovation in life sciences.
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