What I learned Today

Former Women's Health Chief at the FDA Susan F. Wood gave a seminar this morning about emergency contraception (EC). She resigned last year over the approval process for an over the counter (OTC) version of EC.

First, a little FDA 101. The FDA has jurisdiction over about 25 cents of every consumer $1, covering things like prescription and OTC drugs but also product labeling, medical products, and policies related to clinical trials. It does not, however, regulate the practice of pharmacy or medicine - i.e. the FDA approves a drug, but the medical profession determines how to prescribe it and the medical and pharmacist associations determine who is an approved prescriber and things like that (this becomes important later in our story). Companies seeking FDA approval for a prescription drug must show that it is safe and effective, typically through data from clinical trials. Companies seeking OTC approval have to answer three questions - 1) do you need a doctor (or other professional) to diagnose the problem? 2) do you need a doctor (or other professional) to determine the appropriate treatment/action? 3) can you determine how to use the product using only the label? These questions are answered using data from label comprehension and actual use studies.

Now, a little EC 101 - Emergency Contraception is exactly the same as other forms of contraception in that it works along the same physiological mechanisms. EC primarily prevents the fertilization of an egg, and although there is no scientific proof of this ever happening, it is possible that it changes the condition of the uterus to make it less likely that a fertilized egg will successfully implant. This is exactly what an IUD is specifically designed to do. So, again, EC does the same thing as other already available forms of contraception. And it is not, in any possible way, an abortifactant.

Now, on to the approval process for EC. Within the FDA organizational structure there is an advisory committee set up for each drug submitted for approval. This committee makes recommendations, and it is not terribly uncommon for groups or individuals higher up in the organizational structure to overrule these recommendations. It is, however, incredibly uncommon for the decisions and suggestions from every single level of scientific review to be overruled, which is exactly what happened in the case of EC.

In December '03 the advisory committee voted 23-4 in favor of OTC status for EC and voted unanimously that it was a safe drug. This is important to note, because at no point in the approval process was EC ever considered unsafe. From here the application moved up the typical channels within FDA to the level at which agreement would normally result in issuing an official decision.

Instead, in May '04 the application went to the Center Director, who said it was 'non-approvable' (which essentially means there are significant problems that must be resolved) and requested a two-tiered prescription/non-prescription status for EC (making it available OTC for 'older' teens and adults, which means anyone 17 and older and requiring a prescription for younger teens). This was the first mention of the idea that availability of EC OTC might cause an increase in risky sexual behavior among teens. Data exists that shows the only behavior change resulting from increased availability of EC is an increased likelihood that a woman will use EC after a failed primary contraceptive event (which, you know, is sort of the whole damn point of EC). Nevertheless, FDA requested additional data be collected on young teens (which may or may not be a reasonable request, but it is the first and only time FDA requested any additional data on any subpopulation when the available data was considered to be representative of the population for whom the drug/treatment was intended).

Now, in Wood's words, the Center Director is not a bad guy, and he genuinely believed that by compromising with the 2-tiered program they would be able to get approval for EC OTC, at least for women 17 and over, which would be a step in the right direction.

So the company collected more data, and resubmitted the application during the summer of '04. By the winter of '05 it was generally known within FDA that EC would be approved for OTC status. Then, as Wood describes it, silence settled in. She says that everyone she spoke to said they recommended approval months ago and no one had any idea what the hold up was. Every single person Wood knew within the professional approval chain was out of the loop. By summer of '05 there was still no decision, so Congress stepped in and held up hearings on a new FDA director until they agreed to take some 'action' on the EC issue by September.

In August '05 the FDA commissionor says they are ready to approve EC for those 17 and up but that the 2-tiered program is complicated and needs to be opened up for public comment and rule making to determine how to establish regulations. This is, conceivably, a reasonable suggestion. But, as Wood points out, it works out to the same thing as failing to approve EC and is essentially a stall tactic that could take years or last indefinitely. Furthermore, there are already many regulations in place for similar 2-tiered prescription/OTC drugs. For example, low dose ibuprofen is available OTC, but high dose requires a prescription. The nicotine patch is available OTC for those 18 and over, but requires a prescription for younger teens. There is a system in place for these problems/complications. And lastly, these sort of regulations are for the medical and pharmacist associations to work out, it is technically not under the jurisdiction of the FDA to determine how and to whom to make drugs available.

At this point Wood again reminded us that there is NO safety issue here. It is not possible to overdose on EC (unlike several other readily available OTC drugs). Lastly, according to the FDA 'decision making for health policy must be based on scientific and medical evidence [and] must promote health." Wood concluded that this decision did neither, and she resigned in protest.

The bottom line, according to Wood, is that this is an indication that the FDA leadership is NOT independent, which essentially means that the FDA is unable to do it's job, which is to make decisions regarding public health and safety based on scientific evidence.

Once the floor was opened up for questions/comments the dean of our school, Jim Curran, mentioned that politics have long had a negative relationship with the environment and sex (he should know, he was a CDC division director when HIV/AIDS first appeared) and then went on to rail about "these assholes in Congress" and the codification of homophobia in the military (can you imagine losing your job because you stood up and said I'm back? Or I'm female? It's outrageous!). Made me proud that he's our dean, and was a happy reminder that all those people who used to pat me on the head and say I'd outgrow all my righteous indignation were wrong.

So it was a good way to start out my Friday, and hopefully will be a bit of an innoculation against whatever I'm about to expose myself to at the repub convention tomorrow.