FDA Communications Best Practices: Transparency

October 9, 2015 Joe Lamendola, Ph.D.



Many of us remember the classic Fram Oil Filter commercials that demonstrate the importance of addressing small issues before they become big, expensive problems.

The wise mechanic’s line, “Pay me now or pay me later,” became a household phrase. It’s one I still use today when working with biopharmas that are struggling with how transparent they should be with the FDA during the review process and especially at FDA meetings.

My answer is always the same: be completely transparent as early as possible. When it comes to discussing asset vulnerabilities with the FDA, you will do it now or do it later.

Being transparent about all flaws with an asset being developed as early as possible has its advantages. It allows biopharmas to develop a partnership with the FDA and to agree on a plan forward. This helps biopharmas to mitigate risk as they develop their drug, and gives the FDA the opportunity to comment early, avoiding the need for expensive and time-consuming data remediation later.

Early transparency also establishes credibility with the FDA. Hiding vulnerabilities that eventually are discovered just looks bad. Once an FDA reviewer loses credibility in a company, the review process becomes more difficult. For a biotech firm, in which every single month is important to patients waiting for new medical therapies, these delays are especially painful.

Finally, transparency establishes a collaboration with the FDA that paves the way during the entire drug development process and helps pharma companies avoid surprises. This often gives agents the best opportunity for first action approvals.

When dealing with the FDA, the best strategy to adopt is to go into meetings looking to get as much information as possible that will help move drugs along quickly. Sometimes sponsors are concerned that they will hear something that will have a negative impact on their development program. However, the focus always should be on how to facilitate the approval of the drug. Remember, pay me now or pay me later.

An outside perspective from an expert who has been through the approval process always is helpful. To talk with me or another YourEncore expert, please contact us.

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Authored By: Joe Lamendola, Ph.D. is an authority on regulatory affairs and an Executive Partner at YourEncore. He is the former Vice President of U.S. Regulatory Affairs at Bristol-Myers Squibb and responsible for 20+ approvals across 10+ therapeutic areas. 

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