A Challenging Regulatory Environment Means More Care Needed with FDA Submissions

In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.

Life sciences companies currently face numerous challenges when seeking approval for new drugs and biological products. This is partly because the science of new product development has generally become harder, with more companies pursuing therapies in areas that have long proved difficult to crack.

At the same time, the COVID-19 pandemic created lingering difficulties for both life sciences companies and the FDA. These include a reduction in the face-to-face interactions typically needed to reach alignment on thorny scientific and regulatory issues, as well as strains on agency resources. An unfortunate but unsurprising consequence of this has been a rise in disputes between life sciences companies and the FDA.

In such an environment, life sciences companies should increasingly account for the possibility of a significant dispute – or even potential litigation – arising during product development. However, there are also steps that companies can take to reduce the likelihood of a dispute, or to resolve one quickly should one arise.

A key first step is to ensure that the company has thoroughly considered all FDA feedback related to its development program, and has developed a response strategy that fully addresses the feedback. One challenge which can arise here is that written FDA feedback often includes terms that may appear straightforward when interpreted literally, but which have significant additional meaning when read in the context of general FDA practices, policies, and guidance documents that might not be explicitly referenced in the feedback. For this reason, it is important to assess and interpret FDA feedback carefully, and to consider all of the possible nuances that may be at play.

A critical second step is to ensure that key regulatory submissions are drafted with meticulous thoroughness, precision and clarity. In a world where electronic communications reign supreme and agency resources are taxed, the success or failure of a submission is much more likely to turn on its strength as a written document. In order to avoid – or readily resolve – disputes with the FDA, it is more important than ever for life sciences companies to focus on the overall organization and content of their submissions. It is crucial to ensure that all relevant issues are addressed and that the key points can be readily understood.

Some specific tips for drafting an effective submission are:

• Be exhaustive in your research, data gathering, and analysis. Take time to read background documents comprehensively and to pursue new questions that arise as you work. Ensure that what you ultimately write is grounded in your actual findings, rather than in your team’s pre-existing expectations and views.
• Take time to analyze how the specific issues around your product connect to the wider picture of how the product is regulated, to general FDA policies and initiatives, and to any emerging trends in how similar products are faring in the global marketplace.
• Ensure that the arguments on which the submission relies are consistently based on FDA precedents, policies and – whenever possible – sources of authoritative law. Cite specific statutes, regulations, policies and guidance documents to back up your points.
• Clearly state what you are asking for upfront, identifying the key regulatory issues and leading with the key rationale behind your position.
• Organize your argument clearly – either chronologically or by product feature – while avoiding the mention of superfluous dates or events.
• Generally, keep the submission tight and limited to what effectively supports your argument. Ensure that it is complete, but also make it as concise as possible. The language should be accessible and readable, with no unnecessary jargon.
• To boost your credibility, ensure that the submission addresses tough issues and precedents explicitly, rather than glossing over them. Do not shy away from controversial points, for example, issues around lack of agency jurisdiction.

Many of these practices are already familiar to experienced life science professionals. However, they are increasingly important in the current regulatory environment, which has made it business-critical for companies to provide the FDA with clear, compelling, and easy to follow submissions. This not only reduces the likelihood of disputes in the near-term, it also puts companies in a much stronger position if a dispute should arise at some point down the road.

Further blog posts in this series on surviving the current financial and regulatory environment will cover compliance and product launch sequencing.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.