Drug, Device Safety Protected in Cures Act, FDA Chief Says

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By Jeannie Baumann

Sept. 10 — The acting FDA commissioner said Sept. 10 he’s confident the 21st Century Cures bill (H.R. 6) won’t lower the agency’s standards for approving new drugs and devices, but he is concerned the $550 million provided in the legislation won’t cover the costs of implementing all the new directives.

Stephen Ostroff indicated during a health research forum that if the Food and Drug Administration doesn't receive adequate funding, then the new directives may come at the expense of other successful programs.

“Those resources have to come from somewhere,” he said. “There are a number of things that I think we can point to that we’re doing extremely well, and we don’t want to do anything to jeopardize the successes that we’ve had.” The FDA approved a record number of novel new drugs—41—in 2014, including nine in personalized medicine. The speed of approvals for new products also has improved considerably, he said.

“Today, FDA is a considerably different organization than it was in the 2000s or even back in the 1990s,” he said.

Ostroff made his remarks during a panel at Research!America's forum, “Straight Talk: Advocacy for a New Era in Science.” When asked to address concerns that the bill, which the House has passed, would compromise the safety of new medical products, Ostroff said initial drafts contained a number of provisions “that made us somewhat uncomfortable.” But as the House Energy and Commerce Committee worked through the legislation, he said, there was a great deal of opportunity for FDA staff to provide technical assistance. He said these FDA-congressional interactions ultimately left the agency staff feeling very comfortable with the bill's content.

“And I will continue to say that we are content with that bill,” he said. “It does not do things that would significantly cause concerns for us for our ability to do our job effectively, which is to be able to evaluate products for their effectiveness and for their safety.”

New Programs

But the bill would require the FDA to take on new directives in areas ranging from developing programs that incorporate clinical experience into the approval process, to developing a risk-assessment model to incorporate data based on patient experiences, to issuing new guidance on the antibiotic approval process.

“Our focus right now isn’t so much on what the content is, but whether or not we’re going to be able to accomplish everything we’re being asked to do in that bill,” he said.

Ostroff also highlighted two parts of the bill that he said will be critical to improving programs at the FDA. The first gives the FDA greater flexibility in its hiring practices, particularly as it relates to salaries.

“We need really highly skilled individuals to be able to appropriately evaluate some of the things that are coming in to us. We need really, really good people, and it has been a major challenge for us to be able to accomplish that,” he said.

The bill also would exempt user fees from sequestration, which Ostroff said was another critical part of the legislation. The FDA is funded through a combination of appropriated funding and user and application fees paid by drug and device makers. During fiscal 2013, automatic budget cuts enacted through the sequester also affected about $83 million in user fees from drug and device manufacturers.

As the Senate Health, Education, Labor, and Pensions Committee is working on its own parallel bill to H.R. 6 to be released in the fall, Ostroff said about the sequestration and hiring provisions, “Certainly anything that’s going on in the Senate side, we would like to see that preserved.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

More about the Research!America forum is available at http://www.researchamerica.org/news-events/events/national-health-research-forum/straight-talk-advocacy-new-era-science.

H.R. 6 is available at https://www.congress.gov/bill/114th-congress/house-bill/6.

An FDA blog on drug approvals is available at http://blogs.fda.gov/fdavoice/index.php/2015/01/cder-approved-many-innovative-drugs-in-2014/.