Plan B and the FDA

I attended a talk on Thursday at UT by Dr. Susan Wood, former director of the office of women's health at the FDA who resigned last August to protest the unprecedented delays in approving Plan B for over the counter sale.

Here are the highlights:

+ The FDA does not have the power to regulate practice of medicine or practice of pharmacy
+ Plan B was approved by the FDA in 1999 as a prescription drug. It passed all safety tests with flying colors.
+ Plan B is not a "new" product or "new" method of birth control, it's just the first time it's been packaged for this specific purpose. In the past, women just had to know exactly how many birth control pills to take and by when to approximate the same effect.
+Plan B works the same way as the IUD, birth control pill, and breastfeeding, which are not controversial (at least not as birth control).
+ The FDA commissioner, after dragging his feet for months though all his director-type people and their scientific advisory panel were for its approval, finally decided to issue Plan B "two-tiered status," meaning over the counter status for 17-year-old women and over, and prescription status for 16 and under (hello regulation of female sexuality). This seemed better than nothing though, so they waited for the approval. Months passed, but nothing happened. Senators Clinton and Murray (Washington state) pressured the FDA to reach a decision by Sept. 1 2005. The usual decision-makers at the FDA were not involved in the discussions, which apparently were taking place at much higher levels in the government (Dr. Wood stopped short of naming the Bush Administration directly). This had never happened before with any other drug. Normally, if all the FDA people are in agreement it doesn't even go to the commissioner's level.
+ The decision came, and it was pretty fucking sneaky: they wanted to open it for public comment and rulemaking because this dual status thing was going to be difficult to implement/too complex to enforce. So new federal regulations are ostensibly needed, which conveniently takes YEARS. Never mind that the nicotine patch has similar dual status and that was implemented just fine - the prescribers and pharmacists figured it out.
+ Take home message: the FDA was hijacked by political interests and can no longer call itself a science-based, independent organization.

+ Also of interest: these same hijackers are also opposed to a vaccine for cervical cancer - for HPV - because it goes against the abstinence message. Because of course, routinely vaccinating 12 year old girls for the human papilloma virus means that said girls will naturally increase their risky sexual behavior. Dr. Wood raised a scary point: what happens when we get an HIV vaccine? Will the same logic apply?

+ Oh - and there is a petition circulating right now to take RU-486 off the market (even though it is already very tightly restricted in the U.S.)

Dr. Wood is a kickass scientist who is now touring the country trying to tell as many people as possible what really happened, so that we may be as outraged as she is and...well, what to do about it? She didn't have a lot of suggestions, except to get the word out. So I did.

Here's some ideas on how to take action:
backupyourbirthcontrol.org