FDA Credibility on the Line with RU-486

J0302942 Today’s Washington Post carries news of the continued struggle over mifepristone and a renewal of effort on the part of RU-486 opponents to ban the compound because of eight deaths over the past several years.  Four of these have been associated with a bacterial infection, after women used mifepristone.  Representative Mark Souder (R-Indiana) will hold a hearing today and reportedly will spotlight the issue.  The FDA is quoted as saying that it is premature to make a link between the use of RU-486 and the bacterial infection. 

It is a relief to see the agency citing the need to scientifically link the use of the drug with the undesirable outcome, rather than cave into political pressure.  Under this Administration, the FDA has suffered a dramatic erosion of its once gold standard credibility, as I’ve written about several times.  Some of it has not really been their fault (Vioxx).  Some of it, has been due to being asleep at the switch (the flu vaccine shutdown in the U.K.).  Some of it, has been due to a willingness to sacrifice science in the interest of a political agenda (Plan B fiasco, medical marijuana).   

Now, with the RU-486 issue, the agency actually has an opportunity to redeem some of its credibility by being as vocal as possible about the kinds of examinations that must take place before a drug is taken off the market for safety reasons.  They must demonstrate that evidence-based decision-making is in control and that there is not going to be a knee-jerk reaction to eight deaths over several years (with that for a standard, we wouldn’t be left with aspirin on the market).  J0337288 The agency should get out ahead of this issue, by clearly and quite vocally enunciating standards for safety examinations that apply to all drugs, and not react to the RU-486 developments as they happen.  Holding an Advisory Committee meeting or a Part 15 meeting on the topic might be a good idea, especially if they actually follow the scientific advice given, unlike the Plan B situation. 

In fact, it would be ideal if Dr. von Eschenbach would take up those reigns today at the hearing, whether invited or not.  So far, his public utterances have been only of the most vanilla flavor, and it is not doing him or the agency any favors.  The agency needs to be proactive and needs to construct a messaging architecture around this and many other issues, and stick to the program.  From this, the agency could benefit greatly and this may be the time (actually it is past the ideal time) to do it.

After all, public opinion on Administration policy is at an all time low, increasing the chances that at least one of the legislative houses will change leadership, if not both.  What that means for FDA is that there is an ever-increasing chance of some full-fledged investigations into FDA policy as related to Plan B.  There may be hearings today on the dangers of RU-486, but the FDA needs to keep in mind the potential hearings of tomorrow while facing those of today and ensure their actions today don’t make matters worse than they already are for the post-election season. 

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One Response to FDA Credibility on the Line with RU-486

  1. Ed Vawter says:

    Mark, several additional points. Mifeprex (aka RU-486, mifepristone) was co-administrered with misoprostol and so it is unclear which (or both or neither) may be responsible. Also, four of these cases the drug was administered by an un-approved method (vaginally rather than orally).
    Also, infections from this particular bacteria (Clostridium sordellii) seems to be on the rise anyway. There have been 8 cases of death due to this bacteria after normal birth of a child according to the CDC
    FDA infopage: http://www.fda.gov/cder/drug/infopage/mifepristone/
    CDC Information about Clostridium Sordellii: http://www.cdc.gov/ncidod/dhqp/id_Csordellii.html
    QDis Blog: http://www.qdinformation.com/qdisblog/