(Bloomberg) — A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, the nation's chief drug regulator said today.
The program, approved in 2012, can cut the time needed for approval by years, a gain for companies that may be reflected in pricing, said Food and Drug Administration Commissioner Margaret Hamburg. The agency is also trying to work more in parallel with the Centers for Medicare and Medicaid early in the approval process to help companies better understand issues surrounding the value of their potential products.
"If we can lower the costs, we can lower the cost to patients ultimately," Hamburg said. "It really matters for patients, especially when there aren't other effective therapies in a given area."
Hamburg, in a wide-ranging interview, also said the agency is under pressure to extend the comment period for its decision to regulate e-cigarettes and doesn't have near-enough money to successfully implement new food safety laws.
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