FDA Gives Innovation, Harmonization Added Attention In Final Priorities Report
This article was originally published in The Pink Sheet Daily
Executive Summary
Industry comments lead to subtle but notable changes; agency also makes a few deletions, additions of its own including deemphasizing cost-control projects, highlighting antibiotic development and changing the status of its facility improvements.
Industry input led to a more prominent discussion of innovation in FDA’s 2014-2018 Strategic Priorities report released Sept. 30, along with discussion of FDA’s continued commitment to international harmonization.
No other changes were made to the agency’s strategic priorities based on public comments on the draft. However, a comparison of the draft and final versions reveal other tweaks including one that deemphasizes the agency’s focus on projects that will control costs.
FDA received 20 comments in response to the draft report released in late June but none were publicly available in the report’s Regulations.gov docket folder
. FDA said most of the comments fell into one of three categories: comments regarding specific products or policies, comments related to innovation, and comments related to harmonization of international standards.
No changes were made based upon the comments regarding specific products or policies, FDA said.
The report identified five cross-cutting strategic priorities for the next four years:
- Regulatory Science
- Globalization
- Safety and Quality
- Smart Regulation
- Stewardship
The final version placed new emphasis on innovation in the Regulatory Science section, linking regulatory science and product development more closely together.
For example, the report says, “Advancing regulatory science and innovation is fundamental to FDA’s core mission of protecting and promoting the public health.” The draft version did not include “and innovation” in this sentence.
Similarly, the final version includes a discussion of how “tackling regulatory science and innovation needs improves the product development process,” adding “and innovation” when previously just regulatory science was included.
The discussion of international harmonization added to the Smart Regulation section is more substantive.
The new content indicates FDA has been involved in a variety of formal harmonization efforts including those related to drugs and that it will continue working with international regulatory partners towards international harmonization and regulatory convergence.
The Biotechnology Industry Organization told FDA the draft plan “did not adequately address efforts to harmonize the underlying regulatory requirements to minimize inconsistent or redundant regulatory burdens.”
Minor Deletions Could Speak Volumes
Parts of the final document are most notable for what is no longer included.
The draft document included Stewardship, such as doing more with less funding, as a strategic priority, giving this need a higher prominence than previous FDA strategic plans (Also see "FDA Budget Issues Creep Into Strategic Priorities" - Pink Sheet, 2 Jul, 2014.).
However, the final guidance removes a statement that cost-cutting programs might be one way FDA identities way to modernize and maximize efficiency.
The draft sentence said: “FDA is looking at several projects that will help control costs and streamline operations, while maintaining the integrity of programs upon which the public relies, including re-organizing FDA’s regulatory and compliance activities around commodity-based and vertically integrated regulatory programs.”
The final document deleted “that will help control costs” and instead said “FDA is looking at several projects that will enhance policy and strategy development and streamline operations …”
FDA declined to discuss in detail what changes were made to the final document and why, making it hard to read the tea-leaves and understand why the phrase about cost-cutting programs was taken out.
It’s possible the words were removed, but the intent of FDA’s plans remains the same. It’s also possible FDA realized that streamlining operations and re-organizing programs may initially come at an additional cost that pays out over time.
Foreign Collaboration, Antibiotics Gets More Attention In Core Goals
The strategic priorities document also describes FDA’s core mission and goals by laying out four goals which include underlying objectives and strategies. The four goals are:
- Enhance oversight of FDA regulated products
- Improve and safeguard access to FDA regulated products to benefit health
- Promote better informed decisions about the use of FDA regulated products
- Strengthen organizational excellence and accountability
FDA modified a strategy to accomplish the third objective under goal one: strengthening detection and surveillance of problems with FDA-regulated products, to emphasize its collaboration with foreign regulators on inspections. The draft did not include the word “foreign.”
However, while the draft mentioned avoiding duplication of inspections, the final version discusses sharing inspection reports instead.
It’s possible this change could mean FDA is focusing more on looking at its counterparts’ inspections to get additional information, but still conducting its own separate inspections.
Facilitating new antibacterial drug development also got an extra boost in the final version as FDA added it as a strategy to its second objective under goal 2: improving the effectiveness of the product development process.
In the third objective under goal 2, improving the predictability, consistency, transparency and efficiency of the review process, FDA makes another deletion, removing in the final version a clause about the limited availability of investment capital,in a sentence describing the need for early clarification of regulatory requirements given the current economic climate.
The agency also changes its tone about the state of its physical infrastructure improvements in the final document.
While discussing the agency’s investment in infrastructure to enhance productivity and capabilities in the draft, the agency said, “FDA is also near completion of facilities and laboratory improvements and alterations that are necessary to support our strategic priorities.”
The final version removes the statement that these improvements are almost done instead, saying that FDA “will continue a multi-year effort to expand and upgrade its facilities …”
PhRMA, BIO Use Opportunity To Push Other Priorities
Both BIO and the Pharmaceutical Research and Manufacturers of America provided “The Pink Sheet” DAILY with their comments on the draft report. Both organizations submitted lengthy comments, though many of their requests seem to go beyond the scope of the strategic priorities documents and into more specific details of how the groups would like to see FDA carry out the priorities.
For instance, PhRMA uses FDA’s discussion of enhancing oversight of products in the strategic priorities guidance to give FDA comments on how Title VII of the FDA Safety and Innovation Act and the Drug Supply Chain Security Act can be implemented to address supply chain threats.
BIO’s comments ask FDA to elaborate in more detail on how cross-center reviews would be conducted for drug-device therapies.
BIO also discusses the biosimilar pathway, asking FDA to clarify the process and timing for finalizing the current biosimilars draft guidances and for issuing additional guidance on key topics such as interchangeability and extrapolation.