Monday, March 23, 2009

Judge Requires FDA to Reconsider Restricted OTC Plan B Sales

I told you so, there's no medical reason to restrict OTC Plan B sales to those 18 and older:

NEW YORK – The Food and Drug Administration let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication.

In a thorough denunciation of the Bush administration, U.S. District Judge Edward Korman blasted the FDA's handling of the issue, saying it had "repeatedly and unreasonably" delayed issuing a decision on the medication.

The morning-after pill is a source of tension for social conservatives who held great sway in the Bush administration and who believe the pill is tantamount to abortion.

The ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions only took action to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.

"These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making," Korman said. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use."

The drug is marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B. Korman ordered the FDA to permit Barr Pharmaceuticals to make Plan B available to 17-year-olds without a prescription under the same conditions as Plan B is now available to women over the age of 18. He said his order must be complied with within 30 days.

The FDA said it is reviewing the judge's decision. Women's groups said it's unlikely that the Obama administration would appeal.


In February 2001, the Association of Reproductive Health Professionals and 65 other organizations petitioned the FDA to make Plan B available over the counter to all, regardless of age. The FDA did not respond for five years, announcing in 2006 that the petition was denied.

As part of his order, Korman vacated the petition's denial and required the FDA to reconsider its decisions regarding the Plan B switch to over-the-counter use.

There are three things in the linked AP article I find puzzling.

First, the continued use of the zombie mistake -- [Plan B] contains a high dose of of birth control drugs. There's only one drug in Plan B, a progesting. While progestin is one of the drugs found in combination birth control pills, Plan B is not a combination drug. This distinction is important for two reasons. One, there are dedicated combination ECP brands and regimens. Conflating Plan B, a progestin-only brand, with combination brands is inaccurate and can be confusing for patients. Two, a combination pill or regimen has a different side effects profile than a progestin-only one like Plan B. For example, nausea and vomiting are more common after taking a combination ECP brand.

And speaking of MSM articles on Plan B and mistakes, here's one more correction. From this Washington Post article (via):

A federal court today ordered the Food and Drug Administration to reconsider the agency's controversial decision limiting non-prescription access to the morning-after pill Plan B to women age 18 and older.

Can you spot the sloppy reporting misinformation? OTC access to Plan B isn't limited to women. *Men* and women can purchase Plan B, as long as they're 18 and older.

Second, the insistence on passing off the Family Research Council's propaganda skilz as relevant to a discussion of scientific/medical matters:

The conservative Family Research Council said the judge's decision bowed to ideological pressure from the left.

"Judge Korman has accepted lock, stock, and barrel all of the claims of a political ideology promoting sexual license for teens," said Chris Gacek, a regulation expert with the group.

"There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent," Gacek added in a statement.

It's misleading to present silly accusations (incompetent legal decision based on ideology rather than medical evidence), scientific ignorance (promoting sexual license for teens), and bizarre claims about the FDA's regulatory process (Plan B may be given to women under coercion) as informed commentary.

Last, but not least, what exactly is the thinking behind the Obama administration defending the arbitrary restriction on OTC sales of Plan B: "It was enacted during the previous administration, now we're in the White House so, what the heck, let's just go with the flow?" Clearly, as a federal agency, the FDA has to be represented by an administration lawyer. But why does the government have to persist in defending the indefensible?

Bottom line: The decision to require the FDA to allow 17-year-olds to obtain Plan B OTC is a step in the right direction, but we still have to wait and see if the current administration will allow science to govern reproductive health matters.

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