Terra Sigillata

Interesting timing: former US National Cancer Institute director and current acting FDA commish Dr Andrew von Eschenbach is about to go before the Senate tomorrow regarding his nomination for the permanent position. You know that he was going to get reamed over FDA’s delay of over-the-counter approval for the Plan B emergency contraceptive, despite all scientific reasons to move forward.

Well, the Associated Press is now reporting that:

The Food and Drug Administration notified manufacturer Barr Laboratories Inc. Monday that it wanted to meet within seven days to define new steps the company must take in its three-year battle to sell the pill, called Plan B, without a prescription to at least some women.

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89%.

Contraceptive advocates and doctors groups say easier access to a pill now available by prescription only could halve the nation’s three million annual unintended pregnancies, and FDA’s own scientists say the pills are safe. In December 2003, the agency’s independent scientific advisers overwhelmingly backed nonprescription sales for all ages.

You may recall that this episode has been one of the most egregious examples of political interference in the scientific process in the United States. The resignation last fall of FDA assistant commisioner for women’s health, Dr Susan Wood, and her subsequent whirlwind lecture tour of US academic medical centers has left egg on the face of the FDA and the Bush administration.

Dr von Eschenbach is a well-known supporter of the Bush family dating back to his time at M.D. Anderson Cancer Center in Houston. His leadership of NCI has been highly politicized and some cancer researchers feel that he sold a bill of goods to Congress and left frontline scientists holding the bag of his unrealistic claims to reduce the pain and suffering due to cancer by 2015. Beyond the Plan B issue, there is significant opposition to von Eschenbach leading FDA.

So, is today’s reopening of discussions with the manufacturer of Plan B a strategic maneuver to pacify the opposition to von Eschenbach’s nomination and confirmation? Or does he, a physician-scientist, finally see the writing on the wall that women’s health is not an issue to be toyed with?

Regardless, I strongly support the move forward to potentially open up over-the-counter access to Plan B for any woman who has reached menarche. And regardless of the outcome of the current Plan B deliberations, I hope that the Senate will be vigilant and look closely and critically at von Eschenbach’s qualifications and motivations for leading the embattled FDA.

Comments

  1. #1 bob koepp
    July 31, 2006

    Thanks for keeping Plan B “in view.” I’d like to see a coalition of women’s rights organizations put together a national campaign to demand that the FDA fall into line with its own scientific advisors. Plan B can be safely and effectively self-administered. What more needs to be said?

  2. #2 Steve
    July 31, 2006

    I feel I would have to oppose the availablity of emergency hormonal contraception over the counter. Yes, EHC is safe and effective, however, there is a need to check that EHC is needed (i.e. in the case of missed pills), and there is a great opportunity to educate patients about the dangers of unprotected intercourse.

    The straightforward solution would to be to introduce a pharmacy only category for medicines, as exists in the UK and other countries. There was an outcry in the UK when EHC was made available direct from pharmacies. Had it been available from supermarket shelves, the outcry would have been deafening, however it is now widely accepted as being available from pharmacies, and the research I’ve read points to pharmacies being the prefered point of access, especially for teenagers.

  3. #3 Abel Pharmboy
    July 31, 2006

    Thanks, Bob – I truly fear for the future of the FDA as the nation’s drug approval and safety monitoring agency. Yes, more scrutiny and pressure to adhere to the advice of their scientific advisors is crucial. There are a tremendous number of dedicated and thoughtful scientists and docs in the FDA ranks, but it is the leadership that must be viewed with a very critical eye.

    Steve: Yes, I would also share enthusiasm for a pharmacy-only distribution system for EHC in the US. My only concern is that the objections to filling Plan B scripts has already been a problem with faith-based pharmacists and I fear that keeping EHC behind the counter will still unfairly restrict access to young women, especially those in rural areas who may have very few pharmacies from which to choose. States must better articulate the professional duties of licensed pharmacists and establish far better provisions for med access in what should be very rare incidences of conscientious objection.

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