PDUFA 6 procedures will include patients, biomarkers for 2018-2022
- The FDA released the sixth iteration of the Prescription Drug and User Fee Act (PDUFA), which covers procedures, goals, updates and timelines for the period between 2018 and 2022. The fifth and current iteration of PDUFA expires September 2017.
- The new guidance covers the timing of review for NDAs, BLAs and various supplements. It also speaks to communication between industry and the FDA, outlining ways that manufacturers will gain increased access to meetings with the FDA.
- Two major updates include the integration of the patient perspective into the drug development and review process, as well as more flexibility around clinical trial design.
- PDUFA was created by Congress in 1992 and authorizes FDA to collect fees from pharmaceutical drug and medical device companies to provide additional support so that the FDA can expedite the review process and make technological and other upgrades as needed.
The long-awaited PDUFA guidance will go into effect between the end of 2017 and the beginning of 2018.
In addition to expediting the review process, the guidance aims to integrate the patients' voice into the drug development and review process, and to increase the FDA's transparency and rapport with the industry. The new guidelines also address new ways to upgrade the process of dealing with drugs for rare diseases, such as allowing for more flexible clinical trial design and use of biomarkers.
The industry's research and trade associations responded positively to the new developments.
"For nearly 25 years, PDUFA has helped bring innovative medicines to patients by providing greater consistency, certainty and predictability in the U.S. drug review process," said Stephen Ubl, president of PhRMA. "The PDUFA VI agreement is an important step forward in ensuring patient safety, maintaining the FDA’s high standards of regulatory review and promoting timely access to safe and effective medicines for patients."
Patient involvement in the drug development process has become a hot topic within the last several years, especially as technology and social media have given patients a stronger, more united voice. Several tactics that will be used to increase patient involvement include having meetings with patient advocacy groups and integrating patient-reported outcomes into clinical trial design.
"We are especially pleased by the steps that will be taken in PDUFA VI to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions," said Jim Greenwood, CEO of the Biotechnology Organization (BIO).
“PDUFA VI resources, together with FDA commitments to achieve greater efficiency in hiring as well as to increase financial stability and sustainability, will provide the agency with the expertise, tools, and resources it needs to effectively perform its vital mission," he added
- Regulatory Affairs Professional Society The Next PDUFA: New Performance and Procedural Goals
- Biotechnology Innovation Organization Statement
- Pharmaceutical Research and Manufacturers of America Statement
- Food and Drug Administration PDUFA 2018-2022