FDA Matters Blog
Register to get regular updates from FDA Matters FDA Matters Home

Late Friday Afternoon: FDA, Politics, and Scientific Integrity

When my Smartphone delivered an e-mail at 5:12 p.m. on Friday: “FDA approv…,” I knew that FDA had just announced something controversial. All public relations people (including those at FDA) have been taught that late Friday is the time to release stories you don’t want to receive much attention.

Indeed, it was the 5-day emergency contraceptive pill, Ella, that was approved. So far, FDA seems to have achieved its goal of less coverage. But I was left wondering if the announcement required that treatment and why it led one advocate to describe the decision as “further evidence that the FDA is committed to restoring scientific integrity in its decisions.”

Abortion is, of course, one of the so-called “third rails” in American politics. For politicians, this means: if you touch it, you will get burned politically. It has never been easy for FDA either. For many years, they were caught in the middle of Congressional and societal fights over the abortifacient, RU-486.

As I have written before (link below), FDA has been a master of little-noticed decisions that create or re-position a disease category. With the new approval, they seem on relatively safe ground in deciding it is an emergency contraceptive. Apparently, there is a nuance as to whether the drug’s mechanism of actions solely delays ovulation or also makes the womb less receptive to implantation. There may be a theological difference, but I don’t see any practical difference.

Ella’s approval doesn’t seem to have been a hard decision and I can’t imagine FDA found it particularly difficult. By announcing the decision late on Friday afternoon, they probably made it seem more consequential and controversial than if they had sent out a more complete press release at a time more conducive to news coverage.

That brings me back to whether this approval is really about “restoring scientific integrity” in FDA decisions. The comparison is being made to the controversy over Plan B, an emergency contraceptive with a much shorter window of efficacy than Ella.

The main issues for FDA regarding Plan B were: should the drug be available over-the-counter (OTC) without the input of a prescribing physician and whether it should be available OTC for women under 18. In my opinion, these were not primarily scientific issues, but social and societal ones. It is completely unlike the current approval of Ella, which will be dispensed only by prescription and doesn’t raise the same societal issues or maybe doesn’t raise any at all.

I am not defending the Bush administration’s handling of Plan B. They could not have done a worse job and they deserve the criticisms they received. But the administration was probably right that the issues were not primarily scientific ones and required input from politically-accountable levels of the government and elected officials—people who have responsibility for public policy that impacts social and societal interests. The Bush Administration should have been more honest about that, rather than pushing the decision down to FDA officials.

Apart from a couple of decisions like Plan B, which are rare, controversial and were badly mishandled, I don’t see that the agency made scientific decisions during those years that lacked integrity. There are always controversies about application of “safe” and “effective” standards….and accusations that science is being ignored. Ella is science-based decisionmaking and business as usual for FDA, not some restoration of agency integrity.


The FDA press release and the WP and NYT coverage:




An earlier column that is relevant. It includes a brief comment on FDA and pregnancy.

FDA: Invisible Arbiter of What Constitutes Disease

November 19th, 2009

According to Wikipedia, “disease” refers to any condition that causes pain, dysfunction, distress and social problems. What constitutes disease is more varied and changeable than this definition might suggest.

The nature of disease and its constant changes are pertinent to FDA, which often makes decisions on behalf of society that reshape our understanding of disease. Read the rest of this entry »

One Response to “Late Friday Afternoon: FDA, Politics, and Scientific Integrity”

  1. A reader from outside FDA but knowledgeable about Ella has written to say: “You made the assumption that FDA held off on the press release until late Friday afternoon to avoid attention. That is incorrect. Friday was the PDUFA date for the product and there was a lot of activity going on up until the moment the action letter was sent to the sponsor.”

    I do not have specific knowledge of FDA’s situation late last week. The column is built on my reaction to the timing of the release and may have inaccurately ascribed motives to FDA that they didn’t have. Since FDA releases have to be written and cleared in advance, it is certainly possible that, as my reader suggests, the timing last week was driven by when the review division finished their work and issued the approval letter. The division could also have been conscious of the value of finalizing the approval on Friday, but since it was the PDUFA deadline there is no basis to draw that conclusion.

    Ultimately, the article is about politics and science. My point is that there are instances when science is not sufficient to decide questions. FDA is not immune to this tenstion. Plan B approval for Rx is largely a scientific issue, while over-the-counter availability is not. Ultimately, OTC availability of Plan B was decided by a court and Obama Administration officials chose not to appeal the decision.

    Did the Bush Administration’s handling of the OTC application compromise the agency? I would agree it did. But beyond this egregious example, FDA is still an agency that did and still does the best job it can, recognizing that many decisions will be controversial and some will turn out badly. I am very impressed by Dr. Hamburg during her first 15 months.. Her commitment to “science-based decisionmaking” is laudable and welcome. Yet, it will not keep her out of controversy in which the agency’s use and interpretation of science is called into question. I can’t say for sure what that issue will be, but the possibilities include Avandia, the alleged food-surface contaminent BPA, and the revsion of medical device approval standards.

Leave a Reply

You must be logged in to post a comment.

© 2009-2012 by HPS Group. All rights reserved. Permission is hereby granted to those wishing to quote or reprint from this site, providing it is properly attributed to FDA Matters: The Grossman FDA Report™.