PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

Regulatory NewsRegulatory News | 22 August 2016 |  By 

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022.


On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use the user fees from industry, breaking down not only the planned deadlines for new guidance documents and pilot projects but also recurring themes of recent importance, including patient input to the regulatory process, use of real-world evidence, biomarker qualification and increased pharmacovigilance.

Last week, FDA and industry stakeholders met for the first time to discuss these performance and procedural goals for PDUFA VI, with some new buzzwords thrown around, like, “Advancing Model-Informed Drug Development,” and changes to FDA-industry meetings.


One of the major changes on industry-FDA meetings planned for PDUFA VI is a new ability for FDA to provide a written response for pre-IND Type B (end of Phase 1) and Type C meetings.

Howard Hutchinson, VP of US regulatory affairs and policy & global intelligence at AstraZeneca, writes to FDA, cautioning against such written responses, adding: “In the event that the agency deems a written response is appropriate, we strongly recommend that sponsors be afforded the ability to request reconsideration and provide additional rationale to support the need for real—time, verbal interaction through conduct of a face-to-face meeting or equivalent means for pre-IND and Type C meetings.”

Another major tenet of PDUFA VI is the increase in collaborations between different FDA offices in coordinating combination product (drug/biologic-device) reviews. AstraZeneca suggests that FDA's issuance of new and updated guidance documents be accelerated.

“It is our understanding that many of the cited documents are already underway and should be deliverable within a timeframe shorter that the currently promised target date being two years into PDUFA VI implementation period,” Hutchinson writes.

He also adds three more specific requests that AstraZeneca wants to see built into the commitments implementation plan, including:

  • “First, there are two additional needs within the industry around combination products, not specifically called out in the letter, that we recommend incorporating into deliverables under Section S.b.: Better defining the applicability of 21 CFR 820.30 (design controls and risk management) to combination products and specifically to the drug and biologic constituent parts of combination products (September 30, 2018); Better defining regulatory assessment of changes made to a combination product after approval within a risk-based paradigm (September 30, 2018)
  • Second, we recommend the addition of one clarification during the implementation of Section S.h, as follows: Placement of device information within the electronic format eCTD submission specification with a focus on harmonization with international regulatory agencies (i.e., avoid placement of region specific content in core dossier sections). This will greatly assist industry in managing application content through the product lifecycle.
  • Third, and lastly, we recommend a new item during implementation of Section 5 (S.i.), as follows: FDA should establish policies and procedures to allow the Office of Combination Products to receive requests for formal meetings relevant to submissions for combination products; with a particular focus on: combination product requests for designation, discussion of relevant regulatory requirements for combination products, and resolution of scientific or policy issues between FDA Centers.”

Another important part of PDUFA VI will involve the expansion of the quality and quantity of data available through FDA’s postmarket surveillance system, known as Sentinel.

AstraZeneca is calling for industry sponsors to gain better access to Sentinel data as sponsors “have an obligation to conduct robust safety surveillance on their products.” In addition, Hutchinson points out that the current goal letter commitments “do not explicitly note intent to use Sentinel data in signal detection, only in signal evaluation. Sponsors should be informed if the FDA plans to use Sentinel for routine signal detection, as this will likely generate more signals that will require investigation by Sponsors and more company resources devoted to this activity.”

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