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.
The comments on treatment costs come as cancer doctors are set to discuss the cost of cancer care starting later this week and controversy is rising over an $84,000 hepatitis C cure. Gilead Sciences Inc.’s hepatitis C pill Sovaldi was approved in December and has drawn ire from Congress and patient groups for its price tag.
The pilot program with CMS is only available now to medical device companies though may be opened to medicines at a later time. In addition, the breakthrough review pathway at the FDA pinpoints promising treatments and assigns companies additional agency guidance throughout development.
The FDA proposed April 24 that e-cigarettes face regulatory oversight, including passing a review to stay on the market, for the first time. The rule, if made final, would extend FDA’s reach over the tobacco industry that began in 2009 with cigarettes.
While the current comment period ends July 9, the agency has received more than 10,000 comments, many requesting an extension to consider the details and complete research. .
The FDA must make a decision “soon” on the requests, Erica Jefferson, a spokeswoman for the agency, said.
“We feel some real-time urgency,” Hamburg said in reference to when the FDA would finalize the proposal.
The agency is also being pushed to step up its food safety efforts and estimated it would need as much as $450 million to implement a 2011 law that expands inspections and raises the agency’s presence on U.S. farms. Congress has allocated the FDA $78 million, Hamburg said.
Implementing the law is “a huge, huge task. Support for the Food Safety Modernization Act is one area of continuing budget need,” she said.
Obama’s budget request for 2015 includes $253 million to implement the act.