The California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) have released a report highlighting the critical role of the U.S. Food and Drug Administration (FDA) in today’s biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process.
The report, , titled “Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry”, has underlined that an increasingly unpredictable approval process at the FDA has negatively impacted public health, the economy, job creation, American competitiveness and innovation.
This report represents the first study to quantify approval timelines and trends over the past decade across both pharmaceuticals and medical devices using FDA and other data.
According to the study’s findings, when comparing the most recent year with the average for 2003-2007, review times for drugs and biologics have increased by 28%; while for medical devices, 510(k) clearances have slowed by 43% and PMA approval times have lengthened by 75%.
“Patients here in the United States ultimately suffer when there are delays in bringing new medical discoveries to the market,” said David Gollaher, Ph.D., president and CEO of CHI, an entity that represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organisations.
“With foreign regulatory agencies, such as the European Medicines Agency (EMA), focused on enhancing the competitiveness of their industry as well as the safety of new drugs and devices, inefficiency at the FDA has resulted in American inventions being made available to patients and physicians in other countries first.”
The report found that in recent years there has been wholesale movement of clinical trials abroad as well as new product launches targeting Europe years before the U.S. As far as the impact on pharmaceutical and medical device jobs is concerned, this shift has pushed jobs and revenues offshore, helping other nations gain experience in building infrastructure and scaling up new biopharmaceutical and medical technology products.
The report also cites the financial crisis of recent years as a contributor to the worsening biomedical innovation environment. Combined with regulatory uncertainty at the FDA, companies’ ability to secure necessary investment capital has been sharply reduced.
The FDA’s expanded data requirements, changing clinical trials protocol, and lack of consistency all lead to high levels of regulatory uncertainty.
“While this may have been uncomfortable in good economic times, it has become intolerable after the crash,” said Simon Goodall, a partner in BCG’s Health Care Practice. “The business risk posed by regulatory uncertainty has increased sharply since 2007. With less capital available, the risk of FDA unpredictability and delays is only compounded, especially when European approval often offers a faster and more predictable pathway to commercialisation.”