The FDA has been without a permanent commissioner for about a year. It was exciting when, just a couple months ago, it looked like Dr. Lester Crawford would move up from being the Acting Commissioner to being the permanent Commissioner. Alas, his confirmation was blocked by two Senators and the FDA is still in limbo.
The reason for the blockage is rather substantial - Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) are concerned about the FDA's dragging its feet in making a decision about approval of OTC Plan B contraceptive. The contraceptive is strongly opposed by conservatives, but all scientific evidence states that it is safe and effective, so its prohibition from being on retail shelves appears to be entirely political. As the FDA is supposed to be making decisions based on science rather than political winds, this is rather alarming.
A month after his nomination was first held up, Dr. Crawford is still working as Acting Commissioner and there does not appear to be an end in sight.
One would think that the administration would like to have a permanent Commissioner in there to help guide an agency that is crucial to public health, that has faced more than a few crises of public confidence in the last year, and that would create stability for administration policy. Alas, it doesn't appear high on the administration's radar.
The Chicago Tribune published an article today talking about how the FDA lacks any real leadership with Dr. Crawford still in this "almost... but not quite" Commissioner position. It notes that it really might be to the administration's advantage to not have someone in there who may make decisions that anger Christian conservatives.
Besides being a potential betrayal of public trust because it looks like the FDA is making decisions that aren't so much based in science as a fear of losing a political base, the FDA runs the possibility of losing the trust of the pharmaceutical and biotech companies. While many may think it's a good thing to strike fear in the hearts of BigPharma, it seems to me that a different result would occur. Holding up drugs for political reasons could actually further stifle any sort of innovation and cause more companies to research "me too" drugs instead. Why not? If you're just coming up with a slightly better version of a drug that's already on the market, the chances are even greater that you won't run into political wranglings. If the FDA sticks by a policy of holding up drugs that some people may find offensive (and don't get me started on how quickly Viagra was approved), companies may decide that it's really not worth trying to come up with a cure or treatment for some condition.
Getting back, then, to leadership in the FDA, I would proffer that perhaps Dr. Crawford really isn't the person who should be the next Commissioner. He seems like a very bright person, but hasn't shown any .... well, "oomph." The administration seems to have made it clear they don't want someone in there who is proactive, dynamic and trying to shake things up (unlike the nominee for the UN, but I digress... ). I really don't mean to make this some sort of political soapbox, as it's unusual for any administration to put in place an individual who might not follow administration directives. But this is a time when the number one agency for approving of medicines that are going to treat our children, our parents and ourselves is facing a big black mark on its integrity. This is the time to call in someone with a strong personality whose primary job is just to plug up the holes, raise morale and follow the stated directives of the agency - to allow drugs that are safe and effective on the market and to keep drugs off the market that aren't. If a consumer has a personal ethical problem with a drug, it's up to them, IMO, to keep away from it and to educate their own families about why they think a certain drug is harmful/immoral/what-have-you.
If anyone reading this knows of a dynamic physician and/or researcher with some business savvy who could motivate the troops and clean up the mess, please let me know.
A dynamic physician and/or researcher with some business savvy you are looking for will be crucified.
S. H.
Posted by: Sin Hang Lee, MD | May 12, 2005 at 09:05 AM