The U.S. House of Representatives approved a bill Wednesday to increase user fees paid by pharmaceutical and medical device manufacturers looking to bring new products to the market. The bill passed easily by a vote of 387-5.
The principal focus of the FDA Reform Act is to recalculate fees from drug and device manufacturers to help speed FDA evaluation of new medical products. The $6.4 billion deal between the FDA and medical companies, in which the companies agreed to pay higher fees to support a faster approval process, will fund reviews through 2017.
The bill also gives the FDA more authority to prevent drug shortages and to expedite the review and approval of medical devices.
The FDA is committed to speeding up its process but needs more personnel in order to make a measurable difference, FDA Commissioner Margaret Hamburg, MD, told an audience at NEHI’s Bridging the Innovation Gap conference in Boston on April 26.
“The same people that are doing the reviews are developing the guidances and going out into the communities,” said Hamburg. “They are being asked to do too many things at once. They burn out and we have rapid turnover. It’s a terrible downward spiral that will serve no one. One of the things that has been such a struggle is that the agency has been unbelievably stretched for resources”
“Our record shows our ongoing commitment to advancing regulatory pathways and bringing medical products to patients as quickly as possible,” said Hamburg, adding that the agency is always “exploring possible new pathways to expedite the approval of breakthrough therapies.”
Hamburg may soon get her wish for funding to hire more regulators. The Senate passed a version of the FDA Reform Act on May 24 by a wide margin. Both houses of Congress will now meet to work through any differences in the legislation. A final bill is expected by July 4.