Thursday, December 07, 2006

By the Grace of Barr Labs and the FDA Plan B Now Available "OTC"

NEW YORK - A month after distribution began, the over-the-counter version of the morning-after pill is now available at pharmacies nationwide. Planned Parenthood celebrated Wednesday with a free giveaway of the emergency contraceptive, while critics insisted that Plan B's accessibility will soon be a cause for regret. [Muwahahahaha]


Carol Cox, a Barr Pharmaceuticals spokeswoman, said the Plan B distribution went smoothly, but she would not specify how many pills were issued. She said the company does not expect detailed sales information until February.

The cost of a standard two-pill pack varies. Kate Horle, a Planned Parenthood official in Colorado, said prices there range from $30 at her organization's clinics to $61 at some supermarket-based pharmacies.

While some independent pharmacies are not stocking Plan B because of moral objections or perceived lack of demand, the pill is widely available. Major pharmacy chains such as CVS Corp., Rite-Aid Corp. and Walgreen Co. not only offer the pill throughout their networks, but also pledge to ensure that customers can buy Plan B onsite even if a given employee declines to provide service for reasons of conscience.

A CVS pharmacist who has qualms about selling Plan B must arrange for another employee to sell it, and the pharmacist must ensure that the customer "is served promptly and treated with respect," the company said.

Jackie Payne, government relations director for the Planned Parenthood Federation of America, said some pharmacy chains were less explicit in their commitments, but overall she was pleased by the industry's reception of over-the-counter Plan B.

"It's been a dramatic change in terms of access, of commitment to stock the pills and ensure that women receive service in the store without delay," she said.

And just in case you're becoming desensitized--grateful to jump through hoops for a chance to be allowed supervised access to Plan B--let's recapitulate:

(1) There's no medical reason to restrict Plan B sales to people 18 and older.

(2) The FDA (possibly, for the first time?) did not use science to rule on a drug application. [Age 18 was picked because [l]everaging well-established state and private-sector infrastructures will allow for comprehensive and effective enforcement of the age-based restrictions.]

(3) Dr. Steven Galson, Director, Center for Drug Evaluation and Research, and the person in charge of making public health decisions about Plan B, admits he is not familiar with the side effects of Plan B.

(4) The White House, it appears, had (unprecedented?) input in the FDA's Plan B application decision.

(5) Plan B sales are contingent on a surveillance program* [Barr Labs' CARE (Convenient Access Responsible Education) program. On of its aims is monitoring efforts to assess whether the Rx/OTC age distinction is understood and adhered to.]

*I've received a report from one of the LJ Birth Control community moderators about a possible attempt to capture personal information at Wal-Mart.

First, according to the FDA (.pdf), only proof of age is required (Furthermore, since Plan B® has both Rx and OTC labeling, pharmacies will keep Plan B® behind-the-counter, and either a prescription or government-issued proof of age will be presented before sale of the product.)

Second, just because you're buying Plan B, does not mean that Wal-Mart (or any other store, Barr Labs, or the FDA, for that matter) has the right to violate your privacy by capturing/using your personal information. The CARE program notwithstanding, they still need your permission to use identifiable information.

Third, I did check with my local Duane Reade (a city-wide chain) pharmacist and he said they've received no instructions from Barr Labs or the FDA to gather personal information.

Last, but not least, when you go to buy Plan B, go prepared. Challenge any intrusion attempts. Ask questions ["What are the legal requirements to purchase Plan B?", "Why does the store need my personal info?", "Who instructed you to take down this information?"], and refuse to give out any personal information. Most importantly, if possible, document the interaction and let one of us bloggers know, so that we may publicize these incidents.

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At 2:00 AM, Blogger Kevin T. Keith said...

The bit about collecting private information is worrisome, but from reading the original post I'm betting that this is just typical retail intrusiveness, not necessarily a BC-surveillance program. Pharmacies here in New York typically ask for name, phone number, and address for every prescription, not just BC, I think so they can follow up if necessary. And some stores collect phone numbers or even addresses to build customer databases (used to be you couldn't buy a freakin' battery at Radio Shack without filling out an entire form).

I agree it's intrusive; they ought to be asked not to do this for non-prescription birth control. But I think the approach is probably best to point out that it makes people uncomfortable, not to accuse them of spying. Though I wouldn't put such a thing past the Bush administration, I suspect the pharmacies themselves are just doing it because it's what they do for other behind-the-counter meds.

At 6:56 PM, Blogger ema said...

Kevin T. Keith,

Agree about the original post--not clear what the intent was. However, I'm not too keen on the "makes me uncomfortable" approach. It puts the person on the defensive, and sounds like s/he is asking for a favor.

I'm more for taking every opportunity to point out the lack of science behind the FDA's Plan B decision. So, accusing all involved parties of ignorance should do the trick.


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