Senate panel urges medical innovation

FDA, NIH leaders testify on dearth of cures
By Bernie Monegain
09:06 AM

Chronic disease could be a thing of the past, if National Institutes of Health Director Francis S. Collins, MD, has it right.

Testifying Tuesday before a Senate Committee, Collins said the NIH was prepared to launch a national initiative with a million or more volunteers who would help researchers unlock the secret to preventing chronic disease.

The hearing closely follows an announcement by President Obama last February of a $215 million Precision Medicine Initiative that includes interoperability standards.

[See also: Obama puts precision medicine on radar.]

"This venture will pioneer a new model for doing science that emphasizes engaged participants, technologically advanced collection of many different data types, responsible data sharing, and privacy protection," Collins told the panel.

Collins and FDA Commissioner Margaret A. Hamburg, MD, testified before the Senate, Health, Education, Labor and Pensions Committee. HELP, as the panel is often called, is chaired by Republican Sen. Lamar Alexander from Tennessee.

The purpose of the hearing, Alexander said, was to “examine how we get drugs, devices and treatments from the discovery process through the regulatory process into our medicine cabinets and doctors’ offices. This work will affect every single American," he said in his introductory remarks.

The bipartisan initiative is presented jointly by Alexander and Sen. Patty Murray, a Democrat from Washington.

"Today discoveries supported by NIH often do not come to FDA’s door for six, eight, 10, or even 12 years," Alexander noted at the opening of the session. "And the average cost to get a single drug from the laboratory through the approval process to the medicine cabinet is, according to some estimates, about $1 billion. Other estimates say it’s double that or even more.”

But, FDA Commissioner Hamburg countered in her testimony that FDA had done more in approving new drugs than at another time in history.

"This past calendar year, FDA approved 51 novel drugs and biologics, the most in almost 20 years," she said in her testimony. Today, FDA’s average drug review times are consistently faster than other advanced regulatory agencies around the world, providing Americans earlier access to new, innovative drugs than patients in any other country."

Both Hamburg and Collins called attention to the BRAIN initiative launched by president President Obama in 2013. BRAIN is an acronym for Brain Research through Advancing Innovative Neurotechnologies.

[See also: Obama unveils $100M BRAIN Initiative.]

NIH and the FDA are partnering with colleagues at the National Science Foundation, the Defense Advanced Research Projects Agency, the Intelligence Advanced Research Projects Activity, in these efforts.

As for the million volunteer project planned by NIH, Collins noted that a project of this size, would lay the foundation myriad new prevention strategies and novel therapeutics.

See a video of the HELP Committee hearing here.

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