The Senate Health, Education, Labor and Pensions Committee held its first hearing on advancing medical innovation on March10.
Committee Chair Sen. Lamar Alexander noted there is no real political bipartisanship on this issue so it is “an area we ought to succeed in. Every member of this committee is interested in identifying what we can do to make it easier to go from discovery through to the medicine cabinet.”
Discoveries supported by the National Institutes of Health (NIH) can take 10 or 12 years just to get to the FDA’s front door, he said. “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.”
Alexander cited President Obama’s precision medicine initiative and the House 21st Century Cures effort as evidence of interest and momentum in this area.
NIH Director Francis Collins, MD, testified that the organization plans to launch a national initiative with a million or more volunteers that would help researchers find ways to prevent chronic disease. "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 said.
FDA Commissioner Margaret A. Hamburg, MD, also testified, saying the organization has 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. 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."