This morning, I find posts at both Terra Sigillata and Pharyngula discussing the FDA's announcement that they are planning to reopen discussions with Barr Labs, the maker of the Plan B morning after contraceptive, regarding Barr Labs efforts to gain permission from the FDA to sell Plan B over the counter. Both of my SciBlings' articles are cautiously upbeat about this new Plan B development, as are at least some news articles. After reading the letter that the FDA sent to Barr, which putatively formed the basis for the release, it seems clear that the optimistic spin the FDA Press Office is putting on these new Plan B developments is nothing more than a steaming, reaking mound of low-grade bullshit. The FDA is trying to place even more restrictions on the possible OTC availability of the drug, to the point where calling it "Over the Counter" is a sad joke.
Let's look at the text of the press release:
FDA announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older. FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor's amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.
Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B--each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B is currently available to all women as a prescription drug.
In the letter to Duramed, the Agency communicated its plan to proceed working with the Sponsor in order to move Plan B from prescription only to over-the-counter status for woman ages 18 and older. The steps FDA has taken with respect to this application and the letter it issued to the Sponsor of Plan B today underscores FDA's commitment to public health and safety.
This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor's amended application. Foremost in the Agency's concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency's broad and critical agenda forward.
Sounds all nice and touchy-feely, doesn't it? "Committed to health and safety", "novel and significant issues", yadda, yadda, yadda. Lot's of buzzwords, used in a way that almost makes you forget that the novel issues were created by the FDA's unprecedented (and blatantly politically-motivated) decision to ding Plan B for not having evaluated the possible psychological effects of the ready availability of the product on younger adolescents. Isn't it nice to hear that the FDA is moving forward - as they have since 2004 - to resolve the issues created by their political interference in medical decisions?
But wait, folks, it gets better!
In their initial not-approvable letter, the FDA stated that:
Alternatively, you could supply additional information in support of the revised indication to allow for marketing of Plan B as a prescription-only product for women under the age of 16 years and a nonprescription product for women 16 years and older, including draft product labeling. If you take the latter approach, your response to this letter would have to include details of how you propose to implement simultaneous prescription and nonprescription marketing of Plan B for women of different ages in a single packaging configuration while complying with all relevant statutory and regulatory requirements for labeling and marketing of this product.
I don't know about you, but I read that as indicating that they are mostly concerned (at least putatively) with the under-16 age group. Yet, strangely, this somehow managed to shift a bit. Here's what they said after Barr submitted a full application to market the drug over the counter to those 16 and over:
The Center for Drug Evaluation and Research (CDER) has completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product, but only for women who are 17 years of age and older.
It looks like the age range has somehow slipped a year or so there, doesn't it?
All of this brings us to the actual letter that was sent to Barr, and which is (somehow) the basis for the press release quoted above:
Dear Mr. Carrado:
Please refer to your supplemental new drug application (sNDA) dated April 16, 2003, received April 22, 2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Plan B® (levonorgestrel) Tablets, 0.75 mg.
In our August 26, 2005, letter to you we stated that the Agency was unable to reach a decision on the approvability of your application at that time because of unresolved difficult and novel issues raised by your sNDA. On the same day, the Agency issued an Advanced Notice of Proposed Rulemaking (ANPRM) seeking input from the public on certain issues regarding Rx to OTC switches, which related to the regulatory issues raised by your application. The comment period on the ANPRM closed on November 1, 2005, and the Agency received approximately 47,000 comments. FDA then hired a contractor to summarize and categorize the comments, and we received the contractor's final reports on May 19, 2006. FDA has reviewed the comments and, while they have provided the agency with valuable insights regarding how the Agency might enforce an age-based restriction like the one proposed by your amended sNDA, we concur with the overwhelming majority of the comments (from individuals both for and against the approval of your sNDA) that it is not necessary to engage in rulemaking to resolve the novel regulatory issues raised by your application.
We are now proceeding with further evaluation of your sNDA. We would like to meet with you as soon as practicable, and preferably within seven days, to discuss the status of your sNDA, including any necessary amendments. For example, your sNDA seeks approval for OTC use for women ages 16 and older. As we informed you in our August 26, 2005 letter, the Center for Drug Evaluation and Research concluded the available scientific data are insufficient to support the safe use of Plan B as an OTC product for everyone in that age group. Moreover, because of enforcement considerations, we believe that the appropriate age for OTC access is 18. Should you desire to proceed with your sNDA, you would need to amend it to seek approval for OTC status for women ages 18 and older. In addition, you would need to amend your sNDA with respect to packaging.
We would also like to discuss the details of the CARESM Program that you submitted with your sNDA. That program regards your proposed marketing, education, distribution, and monitoring for the OTC version of Plan B. Specifically, we would like to learn more about your proposal to restrict distribution of Plan B to certain pharmacies, i.e., the OTC version of Plan B would not be available at gas stations, convenience stores, etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer. In particular, we would like to learn more about your plan to routinely monitor these pharmacies to make sure they comply with the restricted distribution plan. In addition, we are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them, e.g., whether the restrictions will be incorporated into the terms of a formal contract and, if so, what the terms of that contract (particularly those terms related to a breach) look like. If after our discussions we conclude that the CARESM Program isn't sufficiently rigorous to prevent the OTC version of Plan B from being used by young girls who can't safely use the product without the supervision of a practitioner licensed by law to administer the drug, Plan B will remain Rx-only for women of all ages.
Let's take a closer look at some of the low points, shall we? Here's the one that pisses me off the most:
Moreover, because of enforcement considerations, we believe that the appropriate age for OTC access is 18. Should you desire to proceed with your sNDA, you would need to amend it to seek approval for OTC status for women ages 18 and older.
Enforcement considerations???? What a load of total fucking horseshit. Pardon my language, but what the bloody hell? They've concluded that OTC use of Plan B is safe in 17 year olds, but "enforcement considerations" mandate keeping it from them instead? God lord, what a gawdawful, stinking, disgusting, egregious example of further pandering to the reeking unwashed hordes of sanctimonious wannabe theocrats from the religious right. I mean, really, give me a break. What are they trying to claim here? Pharmacists won't be able to do the math when they check IDs? It will be too expensive to make up some more of those "You must have been born before XX to buy" calendars? Get fucking real.
The rest isn't great, either. This nominally Over-The-Counter drug is only going to be available behind the counter at pharmacies, and then only if the pharmacies manage to fullfill certain requirements, which it appears the FDA are making up as they go along. Ain't that great. We've already got plenty of cases where priggish pharmacists refuse to fill prescriptions for the drug. Are those assholes also going to be permitted to refuse to pass the box to someone? I've got a funny feeling that their "moral convictions" might be allowed to extend to refusing to ring up that particular sale.
The mandate of the FDA is to make sure that drugs are safe and effective. Unfortunately, under this administration, they seem to be more concerned with matters of faith and morals that with their actual mission. This latest episode is simply more evidence that "the Agency's broad and critical agenda" referred to in the press release is nothing more nor less than the agenda of hardcore religious right-wingers.