Tuesday, September 14, 2004

Teenagers: The New Currency

If you happen to run out of money, you can always use teenage girls as barter material. At least, apparently, this is what the FDA thinks.

Barr Labs, the manufacturer of the emergency contraceptive Plan B has resubmitted its over-the-counter (OTC) application to the FDA. The catch? Barr is requesting permission to sell Plan B OTC only to women age 16 and older.

In December 2003 the FDA advisory committees on Reproductive Health Drugs and Nonprescription Drugs voted 23-4 to recommend Plan B for OTC status. However, in May 2004, the FDA rejected Barr's application. Why? Because Barr did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner. [This, unfortunately, is a purely political justification. There's no medical basis for it.]

Bottom line: in order to approve Plan B's OTC status, the FDA gave Barr two options--1) prove the drug is safe for girls through research; or 2) devise a plan that would keep Plan B on prescription-only status for girls younger than 16. Neither option has anything to do with medicine or science. Both are based on political/religious considerations and they're placing Barr Labs in a lose-lose situation. Barr either has to invest additional millions of dollars and wait several years before it can sell Plan B OTC, or it can ignore the medical needs of millions of teenagers.

Barr Labs went with the second option. According to Dr. Scott Spear, chair of the national medical committee of Planned Parenthood:

...Barr's new proposal is a "response to the political realities created by the FDA," adding that FDA's call for an age requirement for OTC status for Plan B is "bogus," adding "one could argue that younger women need [OTC availability] even more than older women who have more resources at hand."

I think Barr Labs' new application is a big, huge mistake. Caving in to idiotic, nonscientific pressures from the FDA in no way serves women's health interests. I understand Barr's financial considerations and I do think the company is entitled to benefit from the sales of its Plan B. I also don't think women age 16 and younger should be sexually active. However, above all, I don't think anyone has the right to treat young women [yes, even insignificant, lowly female teenagers /sarcasm], as political pawns and, in the process, blatantly discriminate against them by endangering their medical care.


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