It might seem obvious that one person alone cannot drive successful FDA advisory committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.
In our last blog, we focused on the non-transparent nature of CHMP meetings – and the challenges sponsors face in making sure that CHMP representatives understand and retain the presenters’ messages.
In this follow up article, we detail how to succeed given an often limited preparation timeline. It requires five key considerations.
The first thing you need to know about CHMP meetings is that they are not public.
Because of this, you can’t research the meeting by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.
Preparing a New Drug Application (NDA) or Pre-Market Approval (PMA) is one of the most arduous tasks regulatory teams have to face – and thinking about a possible Advisory Committee (ADCOM) meeting at the same time may seem impossible. But approaching NDA/PMA preparation with the possibility of an Advisory Committee meeting in mind not only improves a Sponsor’s chances at an ADCOM – it could prevent one from ever happening.
Here are five tips on how to approach NDA/PMA preparation with a possible ADCOM in mind.
For pharmaceutical or device company teams, there is one common thread for all FDA meetings: the need to tell a clear story and to set the data or issue in context. Just as FDA has a process for determining whether a drug or device should be approved, companies need a proven process to keep their team on track and prepare in the most efficient and effective way. Our process includes these seven steps.
Following the results of the Amarin legal judgment, there has been speculation that the ability to promote unapproved, “off-label” claims for prescription drugs will dramatically change. Yet, there are specific reasons why the Amarin First Amendment legal case succeeded and hundreds, if not thousands, of other cases have failed. While the Amarin judgment has set a precedent, it should not have a dramatic change on promotional claim requirements in pharma marketing – meaning that companies do not have First Amendment protection for statements that are untruthful and misleading. It’s not expected that the FDA will diminish the criteria needed to support substantial evidence of efficacy. Instead they will continue to vigorously protect public health and the communication of accurate, science-based information.
As the name implies, the Nonprescription Drugs Advisory Committee (NDAC) is the panel charged with advising FDA on the appropriateness of the RX-to-OTC switch. Therefore, it is essential to understand the common concerns across members of the NDAC and anticipate the questions they will ask at an Advisory Committee meeting to achieve success.
Many new drugs that get to market today are reviewed and approved under one of the Center for Drug Evaluation and Research’s (CDER) expedited approval pathways. In 2015, 27 of the 45 new drugs approved by the FDA were reviewed through an expedited approval pathway. These pathways were developed after criticism from patient groups during the AIDS epidemic in the 1980s that the Food and Drug Administration (FDA) took too long to approve potentially life-saving new drugs. The four main expedited pathways – Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review – offer several opportunities for Sponsors to gain expedited approval and extra incentives when submitting New Drug Application (NDA) applications for drugs intended to treat serious conditions. The programs aim to get important treatments to patients in need as quickly as possible, while still maintaining careful control over safety and efficacy.
So how exactly do these pathways work? What products are eligible for them? When do Sponsors need to apply?
Preparing effectively for an FDA Advisory Committee meeting requires that the Sponsor team anticipate discussion and voting topics that the FDA will pose to the Advisory Committee. These discussion topics and voting questions will influence the information the team provides to the committee and the questions the committee poses to the team. A review of Advisory Committee meetings over the past five years revealed that in more than 40% of meetings, the FDA asked at least one question related to post-approval safety plans.
Gaining regulatory approval as quickly and smoothly as possible is obviously the number one goal for sponsors as they submit their NDA, BLA, or PMA to regulatory authorities including the FDA and EMA. A regulatory submission is the one time when the data don’t speak for themselves – and it’s no time to make mistakes. The reality is that even the best sponsor teams run the risk of falling in love with their data and “drinking their own Kool-Aid.” The good news is there are ways to avoid this common pitfall.