Common Sense Confirmed

Common Sense Confirmed – Study Reveals Talking to the FDA is Good! – From the department of Dog Bites Man, the FDA issued a press release on February 9 revealing that pharmaceutical and biotech companies that communicate more frequently and earlier in the review process with the FDA tend to have better outcomes with respect to their candidate drugs. Duh. Do you think?

Well, I guess it is nice to have common sense quantified.

The 31- page report was entitled "Independent Evaluation of FDA’s First Cycle Review Performance – Retrospective Analysis" was performeed for the FDA by Booz Allen Hamilton. According to the FDA’s press release, 52% of the companies that met with the FDA after Phase II and before beginning Phase III received approval their first try, as opposed to 29% of the companies who did not have a consultation meeting with the FDA at this point. If a drug sponsor met with the FDA even earlier – before even submitting an application – then half were likely to receive approval in the first cycle. You would think this would be common sense, but I guess not, since they did have a cohort of companies who did not confer with the agency prior to submitting their studies.

The report cited several factors as significant contributors to multi-cycle review (instead of getting it right the first time) which included

  • variations in the process across FDA review divisions
  • delay on the part of sponsors in responding to FDA reviewer concerns

It is noteworty that Priority and Fast-Track products have higher first-cycle approval rates. Also, the larger the company (hence the more experienced) then the more likely they would meet with first-cycle success.

What does earlier communication mean? Meetings held at the end of Phase II clinical trials have a much greater impact than pre-NDA/BLA meetings.

Does this sound like rocket science? No. Even so, many years ago I watched two companies come to the FDA to achieve an RX to OTC switch within the same drug class for the same condition, but with different compounds. Company A met early and frequently with the agency and agreed on primary endpoints and statistical significance for their Phase III trials. Company B presented data that raised several questions on how the data was cut. Company A sailed through. Company B was told to try again by the advisory committee reviewing the product. They had a second advisory committee meeting, presenting data that pretty much ignored the concerns raised by the first advisory panel. They failed in their second advisory committee meeting to get approval. It was not until their third advisory committee meeting that they got approval for their product.

So the moral of the study, and of my story is that early meetings pay off, and it pays off to address the FDA concerns, whether expressed by advisory committee members or FDA reviewers. The purpose of the early meetings is to point up potential deficiencies that can be rectified sooner rather than later. So regulatory folks – get a pencil and make note to self – "when going through all the time and expense to develop a new compound, meet with the FDA early and often." Ok?

I hear that another new study is about to come out that reveals that people prefer Fridays over Mondays…

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