Plan B and the FDA

Things don't look good for Lester M. Crawford's final senate confirmation as FDA commissioner. There have been several unfortunate turns of events under his interim watch. One of the most significant is just now starting to unfold.

In December 2003, an FDA advisory committee ruled 23 to 4 in favor of converting Plan B, a "morning after" pill requiring a prescription to over-the-counter (OTC) status. Despite this lopsided majority, in May 2004 the FDA overruled the recommendation and failed to grant approval. Rulings counter to committee recommendations occur but are extremely rare.

Clearly, without direct physician involvement, this would dramatically expand the availability of this form of contraceptive. According to its package insert, Plan B (levonorgestrel) works by a number of different mechanisms one of which may be the prevention of uterine implantation of a fertilized egg. In the eyes of some, this is tantamount to the termination of an incipient life. Because of this, the question of whether this decision was influenced by politics has been raised on multiple occasions including here.

The reason the FDA initially gave for overruling the committee had to do with the safety of this product in young teenage girls who presumably would be using it and with whom only limited safety data was available. I must admit that I was impressed with this argument when this ruling was initially reported. The safety margin has to be extremely wide when dealing with medications that will be administered without the input of a physician such as OTC products.

It now turns out that Dr David Hager, one of the committee members and an openly conservative Christian, recently delivered a speech to a college chapel in which he stated that he was asked to submit a "minority" opinion to the FDA. The FDA denies soliciting such opinions. Hager has apparently given different versions of who invited him to do so. Regardless, his arguments happened to be the same ones cited by the FDA in justifying its ruling.

In his speech, he used the following language:

"I argued it from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision...Once again, what Satan meant for evil, God turned into good."

I have no problem with devoutly religious experts serving on FDA committees, even committees making recommendations regarding politically charged issues such as a morning after pill. To exclude them from participation strictly on the basis of their religious orthodoxy seems manifestly unfair. However, they need to understand quite clearly that it is their clinical expertise that is being sought, not their theology.

When it appears that one's objectivity is compromised by his or her personal agenda, that becomes a problem in the same way that members' financial ties to drug companies constitute a problem when they make recommendations on drugs manufactured by those companies.

I have no proof that Hager was less than objective in his minority opinion. His arguments against approval of Plan B for OTC use may in fact prove prescient. His language during the above quoted speech clearly does not constitute a smoking gun. Without getting into his scientific qualifications or lack thereof, it is disquieting and makes one wonder if his clinical judgement was clouded by his ideology.

The possibility that the FDA approval process may have been corrupted by the political agendas of high ranking FDA officials (or higher) is very disturbing. The FDA's decision-making apparatus must never be driven by mere political expediency. For this reason, the public should demand to know exactly who asked Hager to submit his opinion which happens to be a position ideologically aligned with the Bush administration. This, despite being counter to the committee's overall opinion. If this information is not made available, we'll never know if the process is truly as objective as the public deserves it to be.

I am certainly not qualified to speak authoritatively on constitutional issues but I do know this: The president and the various elements of his administration are charged with the enforcement of federal laws. One set of those laws constitutes the charter of the FDA.

The mandate of the FDA in its current iteration is to ensure that the medications and medical devices used by the American public are both safe and efficacious. Nowhere buried within its charter is there a provision designating the FDA an agent for furthering the political agendas of the executive branch of government's administration du jour.