The U.S. Food and Drug Administration’s review processes, as they stand today, do not adequately keep pace with advances in data.
That reality is the basis of the Bipartisan Policy Center’s new five-point “FDA: Advancing Medical Innovation” initiative.
"Our inefficient, less-than-modern, drug discovery and device approval process drives up cost and delays treatment. We must accelerate the process of getting safe and effective drug and medical devices to patients,” said the initiative's co-chair, former Senator Bill Frist.
"The FDA saw its last major update (in its authorizing statute) back in 1997. That was 18 years ago, and what has happened since in our own lives – the technological advances have been really mind-boggling. They really don't fit, at least in a good way, into a 20th-century regulatory framework."
The problem: Rather than happening in the U.S., drug discovery and device development are increasingly occurring overseas and, what’s more, venture capital investment in medical innovation has dropped some 42 percent since 2007, Healthcare IT News Special Contributor Jack Beaudoin reported on Tuesday.
Also participating in the Bipartisan Policy Center FDA initiative event in Washington, D.C., were Marc Boutin, CEO of the National Health Council, and Mark McClellan, former administrator for CMS and commissioner of the FDA, and now a senior fellow at the Brookings Institute,
"There's been a sea change in both science and the data systems in our country and around the world," McClellan said, pointing to the FDA's own Sentinel Initiative that draws on existing automated healthcare data from multiple sources (including 150 million Americans) to actively monitor the safety of medical products continuously and in real-time.
"But these methods aren't being used for device safety," McClellan added. "And they're not looking at the social networks that patients are using now to discuss effective treatments."
Janet Marchibroda, BPC's health innovation director, said the medical innovations initiative will result in concrete policy recommendations to Congress.
The five key focus areas include: improving time and cost of drug discovery, reviewing the scope of activities with the FDA, advancing the regulatory framework for medical products, strengthening FDA’s ability to carry out its mission, all with an eye on maintaining U.S.global leadership in medical innovation.
"We're moving pretty fast down the road here,” Marchibroda said, “and will be delivering our first recommendations in late spring.”
