US medical device industry and FDA agree on fees (press release)
* Industry to pay $595M in next 5 years
* Missed earlier deadline for fee agreement
* FDA to hold more meetings with devicemakers
WASHINGTON, Jan 31 (Reuters) – U.S. medical device makers agreed to double the fees they pay the Food and Drug Administration in exchange for a more predictable review process for new device applications, people familiar with the deal said on Tuesday.
The industry will pay the FDA about $595 million over the next five years, up from $287 million in the previous agreement, two people said on condition of anonymity.
FDA spokeswoman Karen Riley said the two sides were close to an agreement.
Fees from device and drug companies provide about a third of the FDA’s funding. In return, the agency agrees to specific deadlines for reviewing new applications.
These fee agreements must be renewed every five years and then authorized by Congress. The current fee agreement expires in September.
The device industry and the FDA had missed an earlier deadline this month for submitting an agreement to Congress.
In the past, device companies have clashed with the FDA over higher fees, arguing they have not led to faster review times for medical devices. The industry had also agreed to double fees in its previous agreement with the FDA in 2007.
The FDA and the device industry met at least 29 times over the past year to negotiate fees and other conditions, according to minutes posted on the FDA’s website.
In the final agreement, regulators agreed to meet with device makers halfway through the review process to give the companies more time to respond to questions.
In exchange for higher fees, the FDA also pledged to improve how quickly it reviews devices, and to hire an outside consultant to analyze its review system. (Reporting by Anna Yukhananov)