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Report shows slowing FDA review times

The US FDA's review times for drugs, biologics and medical devices have substantially increased in recent years, according to a new report

The US Food and Drug Administration's (FDA) review times for drugs, biologics and medical devices have substantially increased in recent years, according to a new report.

The research, released jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG), found that review times in 2009 were 28 per cent longer for drugs and biologics, 43 per cent longer for devices seeking 510(k) clearances, and 75 per cent longer for devices with pre-marketing applications compared with the average for 2003-2007.

Called 'Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry' the report found that in recent years many companies have been moving their clinical trials abroad and targeting Europe for product launches well before the US.

"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," said David Gollaher, president and CEO of CHI.

The effect of inefficiencies at the FDA on US biomedical innovation has been magnified by the financial crisis, which has made it difficult for companies to secure investment capital, the report states. "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," according to Simon Goodall, a partner in BCG's Health Care Practice. "The business risk posed by regulatory uncertainty has increased sharply since 2007."

The report points out that budget appropriations for the FDA have failed to keep up with the agency's increasing responsibilities and requirements in recent years.

The report's authors suggest supporting reauthorised Prescription Drug User Fee Act (PDUFA)/ Medical Device User Fee and Modernization Act (MDUFMA) legislation that "appropriately focuses resources on application review times and overall efficiency; establishing more transparency, consistency, predictability throughout the application and review processes; and re-establishing an appropriate balance between benefit and risk."

The report comes just a few days after President Obama announced his fiscal year 2012 budget request for the FDA, which seeks to increase the agency's annual funding from $2.37bn to $2.75bn in a year in which funding for many federal agencies is being cut or kept flat due to concerns about the deficit.

The Alliance for a Stronger FDA, which represents a variety of stakeholders that support increased appropriated funding for the agency, has applauded the president's proposal.

"The President has demonstrated his understanding of FDA's critical mission…and has proposed funding consistent with the demands being placed on the agency," said Nancy Bradish Myers, president of the Alliance and president of Catalyst Healthcare Consulting. "The President has underscored his commitment to deficit reduction, but wisely sees FDA as a necessary exception."

The BCG has the report available for download.

18th February 2011

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