Washington, DC — Zachary Brennan reported on Endpoints News that President Donald J. Trump will sign bipartisan legislation, passed by the U.S. Senate on August 3, that reauthorize the Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.
A spokesman for President Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”
The Senate’s passage of the House bill by a vote of 94-1 — Bernie Sanders (D-VT) was the only vote against — came more than two years after negotiations on the reauthorization began.
A spokesman for President Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”
The Senate’s passage of the House bill by a vote of 94-1 — Bernie Sanders (D-VT) was the only vote against — came more than two years after negotiations on the reauthorization began.
The bill would allow FDA to collect industry user fees through 2022 to help pay for timely reviews of new medical products, in some cases expedite the reviews of certain products and to disclose its progress in meeting new goals.
Industry groups praised the Senate’s passage of the bill.
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued a statement that said the organization “applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts.”
“PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the [FDA] with new tools and resources to keep up with the latest scientific advances,” Ubl said.
“By strengthening the FDA and improving efficiency in the drug review process,” Ubl said, “we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA and patients.”
Ubl continued, “We commend the bipartisan efforts of legislators from both the Senate and House including Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, Ranking Member Patty Murray, along with House Energy and Commerce Committee Chairman Greg Walden and Ranking Member Frank Pallone for advancing this critical legislation.
Ubl added that PhRMA “further look forward to working with the FDA to implement PDUFA VI.”
Brennan provided the following breakdown of some of the highlights from each of the user fee reauthorizations and other provisions.
PDUFA
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) focuses on pre-market reviews, post-market safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.
In addition, the agreement seeks to further incorporate the patient voice into drug development, enhance the use of real-world evidence, improve benefit-risk assessments and expand post-market safety data and evaluations.
GDUFA
The second iteration of the Generic Drug User Fee Amendments (GUDFA II), which creates a new user fee structure and aims to help small businesses, also will speed the review of generic drugs and increase interactions between the agency and generics developers working on complex generics.
MDUFA
The fourth iteration of the Medical Device User Fee Act (MDUFA IV) would increase user fees for device manufacturers by more than $320 million over the next five years in exchange for reducing the average total time to decisions for premarket applications and 510(k) submissions, among other provisions.
BsUFA
The second iteration of the Biosimilar User Fee Act (BsUFA II) would allow for additional communication between FDA review teams and biosimilar applicants in the form of presubmission meetings, mid-cycle communications and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate for additional interactions.
In addition, the next BsUFA would allow, in certain circumstances, sponsors to request a written response to questions rather than conduct a face-to-face or teleconference meeting.
Other Provisions of Reauthorization Bill
The bill also requires that FDA annually publish information regarding the previous year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process.
In addition, the bill revises requirements for performance reports under all the user fee programs to include requiring quarterly publication of information regarding guidance and meetings.
Among the amendments adopted by the House Energy and Commerce Committee were proposals for risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, a pilot project for active surveillance of medical devices and a manager’s amendment that provides a number of technical changes and strengthens the labeling requirements for over-the-counter hearing aids under the reauthorization bill.
Industry groups praised the Senate’s passage of the bill.
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued a statement that said the organization “applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts.”
“PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the [FDA] with new tools and resources to keep up with the latest scientific advances,” Ubl said.
“By strengthening the FDA and improving efficiency in the drug review process,” Ubl said, “we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA and patients.”
Ubl continued, “We commend the bipartisan efforts of legislators from both the Senate and House including Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, Ranking Member Patty Murray, along with House Energy and Commerce Committee Chairman Greg Walden and Ranking Member Frank Pallone for advancing this critical legislation.
Ubl added that PhRMA “further look forward to working with the FDA to implement PDUFA VI.”
Brennan provided the following breakdown of some of the highlights from each of the user fee reauthorizations and other provisions.
PDUFA
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) focuses on pre-market reviews, post-market safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.
In addition, the agreement seeks to further incorporate the patient voice into drug development, enhance the use of real-world evidence, improve benefit-risk assessments and expand post-market safety data and evaluations.
GDUFA
The second iteration of the Generic Drug User Fee Amendments (GUDFA II), which creates a new user fee structure and aims to help small businesses, also will speed the review of generic drugs and increase interactions between the agency and generics developers working on complex generics.
MDUFA
The fourth iteration of the Medical Device User Fee Act (MDUFA IV) would increase user fees for device manufacturers by more than $320 million over the next five years in exchange for reducing the average total time to decisions for premarket applications and 510(k) submissions, among other provisions.
BsUFA
The second iteration of the Biosimilar User Fee Act (BsUFA II) would allow for additional communication between FDA review teams and biosimilar applicants in the form of presubmission meetings, mid-cycle communications and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate for additional interactions.
In addition, the next BsUFA would allow, in certain circumstances, sponsors to request a written response to questions rather than conduct a face-to-face or teleconference meeting.
Other Provisions of Reauthorization Bill
The bill also requires that FDA annually publish information regarding the previous year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process.
In addition, the bill revises requirements for performance reports under all the user fee programs to include requiring quarterly publication of information regarding guidance and meetings.
Among the amendments adopted by the House Energy and Commerce Committee were proposals for risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, a pilot project for active surveillance of medical devices and a manager’s amendment that provides a number of technical changes and strengthens the labeling requirements for over-the-counter hearing aids under the reauthorization bill.
