Aug 23, 2016 | John Gregory
Medical device companies will pay the FDA nearly $1 billion in user fees for five years beginning in October 2017 under the fourth reauthorization of the Medical Device User Fee & Modernization Act (MDUFA).
When the fees were last negotiated in 2012, the industry had agreed to pay $595 million over five years. The 68 percent increase this time around is less of a hike than companies allowed in the third reauthorization, when fees were doubled from $295 million.
“MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient and consumer representatives,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records and other digital sources.”
The announcement doesn’t include specific details of the draft agreement, which the FDA said will be published in the next few weeks for public comment.
Some aspects of the deal were included in a joint statement from the Medical Device Manufacturers Association, the Advanced Medical Technology Association and Medical Imaging & Technology Alliance (MITA).
The three industry groups said the agreement will require the FDA to reduce the amount of time to review devices and have the agency’s management of the review process go through an independent analysis twice during the five-year agreement. The groups also touted new requirements in the review process, like the FDA providing feedback to companies at least five days prior to a pre-submission meeting.
“This agreement is a big win for patients, industry and the agency, throughout the course of MDUFA IV,” said MITA board chairman Nelson Mendes, who is also president and CEO of Ziehm Imaging in Orlando. “As the medical imaging industry continues to innovate at a fast rate, providing the FDA with the necessary resources to keep pace with life-saving technology through digital health and standards initiatives will ensure that patients have timely access to the most innovative devices and diagnostics necessary for the public health.”
Both the industry groups and the FDA mentioned the extra fees will help the agency hire additional reviewers. Just how many new employees will be added isn’t discussed, though device companies had said in May they wanted 91 new reviewers hired, according to Regulatory Focus.
After the public comment period, the FDA expects to present the final agreement to the next Congress in January 2017, with approval needed before the current agreement expires in October 2017.