Plan B and Joe's Gas 'n Chips Service Station

The FDA announced today approval of Plan B OTC sales to women aged 18 and older. If you're in a celebratory mood, this [lengthy] post is not for you.

As early as last week, when the news that Barr Labs had resubmitted its Plan B application came out, I drafted a post where I was taking names and assigning blame:

Eeny, Meeny, Miny, Moe...Catch the FDA by the Plan B Toe

A Plan B announcement from the Oracle FDA:

WASHINGTON (Reuters) - Barr Pharmaceuticals Inc. has refiled its application to sell the Plan B "morning-after" pill without a prescription, a Food and Drug Administration spokeswoman said on Friday.

FDA spokeswoman Susan Bro gave no other details about the application. Last month, the FDA urged Barr to reapply to sell the emergency contraceptive without a prescription to women 18 and older.

Barr Labs is equally tight-lipped [my guess--Barr refiled with an 18 yo age limit]:

Barr spokeswoman Carol Cox declined to comment. The company originally had sought approval to sell Plan B over the counter without an age limit but later revised the request to 16 and older at the FDA's suggestion. The drug can prevent pregnancy if taken within 72 hours of sexual intercourse.

Fortunately, I have a few things to say. What we--the little, insignificant peasants, unworthy of being exposed to too much information--are witnessing here is an escalation in the slide down the slippery slope which started the second Barr Labs threw science out the window and filed the original age-restricted application for OTC sales of Plan B.

Granted, since the battle to use science as the standard for Plan B sales has been so abjectly lost, this course of events isn't such a big surprise. Still, it's breathtaking to observe how much the situation has deteriorated. We are now at a point where the FDA can make any cockamamie demand [why 18 yo? Why not 17.3 yo, or 48 yo?] of Barr Labs, and not only is the expectation (or, unfortunately, demand) that FDA decisions be science-based off the table, but we're to tremble with gratitude for any scraps thrown our way.

To refresh your memory, from the GAO's report, Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual (.pdf):

Fourth, the rationale for the Acting Director of CDER‚'s decision was novel and did not follow FDA‚'s traditional practices. Specifically, the Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents. He also stated that it was invalid to extrapolate data from older to younger adolescents in this case. FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency has considered it scientifically appropriate to extrapolate data from older to younger adolescents.

...

There are no age-related marketing restrictions for safety reasons for any of the prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. All FDA-approved OTC contraceptives are available to anyone, and all FDA-approved prescription contraceptives are available to anyone with a prescription. For hormonal contraceptives, FDA assumes that suppression of ovulation would be the same for any female after menarche,13 regardless of age. FDA did not identify any issues that would require age-related restrictions in its review of the original application for prescription Plan B, and prescription Plan B is available to women of any age.

As much as I'd like to place all (or even most of) the blame on Barr Labs, I can't. Sure, ideally, it would be great if Barr Labs morphed into The Intransigent Defender of Scientific Accuracy (TM) and refused to give in to the FDA's capricious demands. However, in real life, Barr Labs is a for-profit company, and its bottom line in this predicament is financial. A company with a safe, useful drug has both an expectation of profit, and a duty to work to insure a ROI. One might not be too keen on the methods employed by Barr Labs--asking "How high?" when the FDA tells it to jump--but its motivation is perfectly valid.

Tragically (yes, tragically!) the same cannot be said about the FDA. The agency's suggestion that Barr Labs should reapply to sell Plan B OTC to women 18 and older is indefensible. There is no more medical justification to restrict Plan B sales to women 18 and older, than it is for sales of the drug to be restricted to males only.

Last, but not least, while I'm assigning blame here, let me point out that we, the public, also share some (?most) of the blame. When it comes to our health, it is our duty to police government bureaucrats, politicians, and assorted extremists. The first two groups work for us; the last one has no standing in individual health decisions, and its ever-present fantasy of lording over the rest of us must not be permitted to play any part in medicine.

By acquiescing to the substitution of the scientific standard with the eeny-meeny-miny-moe one in exchange for some vague promises of Plan B OTC availability we have been, and continue to be, complicit in our own downfall.

Allow the FDA's "suggestion" for age-restricted sales of Plan B to stand, in hopes that this little horse-trade will insure that--maybe, perhaps, at some point in the future--at least some patients who need this drug will have OTC access to it, and the next time the FDA "suggests" to a pharma company to restrict sales of its drug to blond, Caucasian women, 5'3" and under, or to men in the $150,000 and higher income bracket, there will be nothing left to say.

After reading what I wrote last week, if you thought I was miffed then, check me out now.

Today, the FDA announced it has approved OTC sales of Plan B for women 18 and older.

In his munificence, Dr. Andrew C. Von Eschenbach* (.pdf), the acting FDA Commissioner (you know, the one whose Senate confirmation depends on some OTC availability for Plan B), deigns to memo us on why he has determined that to best protect and promote the public health, non-prescription Plan B should be available for ages 18 and above. (emphasis mine)

That is, despite the fact that, according to Almighty Dr. Von Eschenbach's own memo, the FDA's Center for Drug Evaluation and Research (CDER) found that for women 17 and older the existing Rx dispensing requirements for Plan B are not necessary to protect the public health and that an Rx-only to non-prescription switch for those consumers is authorized under 21 U.S.C. 353(b)(3) and 21 CFR 310.200. (emphasis mine) And, also, despite the fact that, when it comes to the scientific evidence about Plan B's OTC availability to those 16 and younger, Don Dr. Von Eschenbach just lies. [In his memo, he states that CDER also determined, however, that Barr had not established that Plan B could be used safely and effectively by young adolescents--girls 16 and younger--for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug. As a result of this scientific conclusion (with which I concur), Plan B may not lawfully be made available without a prescription to this group under section 503(b) of the Federal Food, Drug, and Cosmetic Act. (emphasis mine) Except, and I apologize in advance for shouting, THERE IS NO SUCH SCIENTIFIC CONCLUSION. The CDER (or more precisely, its director, Dr. Steven Galson) did, indeed, make that determination. However, according to CDER reviewers, the GAO, and the relevant medical literature, Dr. Galson's determination was not science-based.]

*[Technical note to the bozos at the FDA: If you thought that by making it impossible to paste and copy text from Overlord Von Eschenbach's memo, you'll dissuade me from exposing his caca, you were sadly mistaken!]

So, ready to find out why Our Beloved Leader Dr. Von Eschenbach picked age 18 as the cut-off age for OTC sales? Because, in His own words (emphasis mine):

Leveraging well-established state and private-sector infrastructures will allow for comprehensive and effective enforcement of the age-based restrictions.

You know, when I wrote last week's post, I thought I was exaggerating for effect when I warned about the possibility that, in the future, the FDA will be making medical decisions based on hair color and/or income bracket.

Well, the future is now and, in stunned disbelief, I admit I stand corrected. Reality has managed to surpass my wildest exaggerations. As per the Acting FDA Commissioner's admission, the FDA has now made a medical decision based solely on the state of the current enforcement infrastructure, and ease of enforcement.

'Cause that's how medicine works: It's not a drug's age-related effects, if any, that determine if an age-restricted use is warranted, it's how well equipped Joe's Gas 'n Chips service station is to card people.

One more thing. Because Dr. Von Eschenbach's memo mentions the FDA's Center for Drug Evaluation and Research (CDER) and his Director, Dr. Steven Galson, and because I noticed that the FDA's Plan B drug info page also features a memo from Dr. Galson, in the interest of accuracy, I felt compelled to read Dr. Galson's memo (.pdf). [Cuss word....cuss word...cuss word.] As regards today's announcement, the memo doesn't add anything of value (although, the outline of the planned bureaucratic enforcement bonanza and financial waste is illuminating); same old, same old pile of you-know-what. But leave it to me to find a gem in the pile.

Read this and weep:

As I noted in my August 26, 2005, memo, various CDER reviewers recommended that Plan B should be switched OTC for the entire population of women who might use the product, including women under age 18. Similar views were expressed by various CDER reviewers in this review cycle (see for example, August 22, 2006, review of the Director, Office of New Drugs, the Director, Office of Nonprescription Products (ONP), and the Acting Director, Office of Drug Evaluation III). For the same reasons described in my August 26, 2005, memo, I do not agree with those recommendations.

I would, however, like to clarify for the record a statement in my August 25, 2005 memo. On page 5, I stated that if Plan B was used routinely for contraception (a use inconsistent with the labeling), the wellknown risks associated with hormonal contraceptives, such as blood clots and stroke, are likely to be higher than with the use of other contraceptives. While it would be inappropriate to use Plan B for routine contraception because this dose of levonorgestrel has not been shown to be safe and effective for such a use, the relationship between progestin-only oral contraceptives, such as levonorgestrel, and strokes and blood clots has not been fully defined. This clarification does not change my view that the sponsor did not establish that Plan B can be used safely and effectively by women under 17 without the supervision of a licensed practitioner.

(emphasis mine)

Dr. Steven Galson, Director, Center for Drug Evaluation and Research, and the person in charge of making public health decisions about Plan B, either does not know what the side effects of Plan B are, or he does, but lies about them in official government records. Either way, he still gets to decide what's best for your health.

That's it for now. In the next installment, I take a look (oh, who are we kidding? I do way more than just take a look.) at assorted PR releases and media reports on today's announcement.