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Regulatory Focus™ > News Articles > House Committee Unveils Intent to Overhaul FDA Regulatory Framework

House Committee Unveils Intent to Overhaul FDA Regulatory Framework

Posted 01 May 2014 | By Alexander Gaffney, RAC

A bipartisan group of legislators on the House Energy and Commerce Committee has launched a new initiative its members are calling the "21st Century Cures Initiative," aimed at accelerating "the pace of cures and medical breakthroughs in the US."

In a statement released on 30 April 2014, E&C committee members Fred Upton (R-MI) and Diana DeGette (D-CO) said they're looking to "broadly collaborate" with federal agencies, patients, scientists, academics and members of industry to come up with new ways of taking advantage of scientific advancements in order to bring new treatments and cures to patients.

"From the mapping of the human genome to the rise of personalized medicines that are linked to advances in molecular medicine, we have seen constant breakthroughs that are changing the face of disease treatment, management, and cures," Upton said in a statement.

Target: FDA Regulation

The legislators also made clear that one of the targets of their efforts will be the US Food and Drug Administration's (FDA) regulatory processes.

"Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era," DeGette said. "We have dedicated scientists and bold leaders at agencies like the NIH and the FDA, but when our laws don't keep pace with innovation, we all lose."

Their argument closely mirrors one made at length by Manhattan Institute scholar Peter Huber in his new book, A Cure in the Code. The book argues that scientific advancements, and particularly those related to personalized genomics, should lead FDA to reform its regulatory approach in favor of one that is more tolerant of an individualized approach.

"If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there's not a major gap between the science of cures and the way we regulate these therapies," Upton said.

Listen Mode

For now, though, the committee said it just wants to listen. "We want to know how to close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives," the committee members said.

It's also not clear how much influence the group will have, even if it succeeds in formulating a plan. As Inside Health Policyreported this week, some Democrats on the E&C Committee-which has FDA oversight in the House-said they were skeptical about the plan. Any plan put forth would need to pass the full House, the Democratic-controlled Senate, and then be signed into law by the president.

Notably absent from the committee's statement are any concrete examples about how the current regulatory apparatus may have failed in the past, or be about to fail in the future-an indicator that might otherwise provide insight into the direction of the initiative.

Past statements by Upton, however, indicate that he's interested in four topics:

  • Personalized medicine
  • The use of individual and society networks to understand adversity, such as 23andMe
  • Reducing clinical trial costs through databases and adaptive protocols
  • Making FDA more open to risk

The initiative has already set up a Facebook page and Twitter account, complete with a favored hashtag (#Path2Cures), and Upton and DeGette said the E&C Committee will hold hearings, convene roundtables, solicit input and generate white papers.

21st Century Cures Initiative

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