The US Food and Drug Administration's "increasingly unpredictable" approval processes are negatively impacting the nation's public health, economy, job creation, competitiveness and innovation, a new report claims.
The most recent review times for drugs and biologics at the agency have increased 28% compared with average levels for 2003-27, says the study, which is published by the California Healthcare Institute (CHI) and The Boston Consulting Group (BCG). Mounting criticism and pressure from Congress, the media and consumer advocates have resulted in an FDA that is hindered by a growing focus on potential risks of new products, as opposed to benefits, the author claim.
Patients in the US "ultimately suffer when there are delays in bringing new medical discoveries to the market," said the CHI's chief executive, David Gollaher. "With foreign regulatory agencies such as the European Medicines Agency 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," he added.
The report also finds that, in recent years, there has been wholesale movement of clinical trials abroad as well as new product launches targeting Europe years before the US. 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, say the authors.
The recent financial crisis has contributed to the worsening environment for biomedical innovations, they add; 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," says Simon Goodall, a partner in BCG's health care practice. "While this may have been uncomfortable in good economic times, it has become intolerable after the crash," he adds.
The business risk posed by regulatory uncertainty has increased sharply since 2007 and, 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, says Mr Goodall.
20 years ago, the US Congress recognised that there was a drug lag between the US and Europe. Legislators worked with the biomedical industry to reinvigorate the FDA, and this was the genesis of industry user fees through the Prescription Drug User Fee Act (PDUFA) and the subsequent Medical Device User Free and Modernization Act (MDUFMA). However, due to today's complex competitive landscape, the implications of FDA inefficiency are far greater, say the authors.
With PDUFA and MDUFMA reauthorisations pending, the study calls for: - efforts to focus resources appropriately on application review times and overall efficiency; - the establishment of more transparency, consistency and predictability throughout the application and review processes; and - re-establishment of an appropriate risk between benefit and risk.
"Positive policy, managerial and operational improvements at the FDA, along with constructive legislation and congressional oversight, will encourage biopharmaceutical and device innovation," says Mr Gollaher.
"And working together, Congress, the agency, industry and other stakeholders can maintain the high standards of safety and effectiveness that doctors, patients and their families expect while also strengthening the biomedical sector's ability to attract the investment essential to secure US global leadership in the life sciences into the future," he adds.