A day after the Food and Drug Administration
proposed a new accelerated approval pathway for some medical devices, Commissioner Margaret Hamburg rejected suggestions that the agency's efforts to get products to market faster put consumers in danger.
The FDA has introduced numerous pathways that allow for the accelerated approval of drugs. On Tuesday, the agency issued draft guidance
for a new program providing early access and engagement with FDA staff for devices that offer breakthrough treatments for life-threatening or debilitating conditions. The new program builds on the FDA's Innovation Pathway pilot
launched in 2011.
The initiatives have drawn some criticism that the agency may be approving products without fully vetting them for safety and efficacy.
Hamburg, addressing the Food and Drug Law Institute's 2014 annual conference, argued that faster approval does not mean the FDA is cutting corners.
“No matter what the approval pathway is, we consistently have the same statutory standards of ensuring safety and efficacy before a product is marketable in the U.S.,” Hamburg said. “Increased flexibility does not mean we're abandoning standards or quality.”
The FDA, meanwhile, is trying to balance such concerns with directives from Capitol Hill to be more innovative and flexible in how it reviews products, especially those for which consumers have no other alternative.
“A rigid one-size approach is simply not the answer,” Hamburg said.
Some of the most pointed criticism has come from physicians. A 2012 article in the Journal of the American Medical Association
examined three drugs approved through an expedited process that have potentially serious side effects. The authors warned that doctors should “exercise caution and skepticism regarding new drugs.” A study published in JAMA last year found that drugs approved through the expedited review process were tested on fewer patients
Industries regulated by the FDA say the accelerated programs may be consuming too much of the agency's resources and slowing the process for other applications.
“What happens to drugs that aren't in these pathways?” Virginia Beakes-Read, executive director, global regulatory policy and intelligence, global regulatory affairs at drugmaker Eisai, said during a panel discussion after Hamburg's address. “What about the more mundane things, like if we need to update labeling?” Follow Virgil Dickson on Twitter: @MHvdickson