As many regular readers of this blog might guess, today’s posting is about the Plan B announcement so unexpectedly made by the FDA yesterday that it reportedly even caught the manufacturer of Plan B by surprise. For many months, I have hoped that the FDA would reverse the course of events set into motion by the Plan B fiasco. But this announcement at this time, bears scrutiny.
One thing that this agency desperately needs to help repair its image is to re-establish its credibility, which has been drawn into doubt due to a number of circumstances of which, the Plan B fiasco is only one. The agency, the industry and the American people all rely on that credibility.
But the announcement stated that the agency is creating a pathway for the approval of Plan B occurring on the very day before the hearings in the Senate on the approval of Dr. Andrew C. von Eschenbach does nothing to enhance the credibility of the agency given that the timing is incredible.
Listen to this language taken from the press release. "This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor’s amended application."
For anyone following the issue, this statement appears highly disingenuous. It is a remarkably bad communications tactic and cannot be linked to any coherent communications strategy. The agency has not demonstrated a high level of communications acumen in its crisis, but this is an outstanding example of that.
Senators Clinton and Murray, who have placed a hold on the nomination of Dr. Andrew C. von Eschenbach are not likely to see this move as anything more than the silly and pointless tactic that it is.
It is important to note that the FDA’s announcement only says that they are willing to talk to the manufacturer about how its plans to market could be arranged so that the product is not sold over-the-counter to anyone under the age of 18. That is a promise to consider a new application. A consideration that they could turn down thereafter. Given the track record of those charged with maintaining the agency’s credibility in the past in failing to live up to promises made, it is a wonder that anyone would expect this announcement to offer any sure currency.
Some will seek to say that a hold on this nomination for this reason is not fair and that the FDA needs a commissioner. It does need a commissioner. It is not fair to blame the agency for this. The Administration has ignored the need for a Commissioner for most of its tenure and his now applying a typically ham-handed tactic as some sort of olive branch. It was a mistake, just as it was a mistake to call for a confirmation hearing at this time before this issue was fully resolved and just as it was a mistake to embark on a meddlesome track record of interference with the OTC switch of Plan B. These mistakes should not beget another.
The Senate quite reasonably needs better assurances than it has received in the past from this Administration, that they have stopped playing politics with the science of this important agency. Dr. von Eschenbach deserves confirmation, but he deserves better circumstances. That is not the fault of Senators Murray or Clinton.
On a separate note, Dr. Janet Woodcock’s testimony on RU-486 was finally posted to the FDA’s site, weeks after the fact.
FDA Changes Tune On Plan B
The Food and Drug Administration (FDA) announced today that it would be working with Barr Pharmaceuticals to resolve the remaining policy issues associated with the marketing of [the contraceptive] Plan B as an over-the-counter [OTC] option̶…