Wednesday, April 13, 2005

Plan B Update And Then Some More

According to the ARHP:

The current application to the FDA is for the sale of Plan B OTC for women age 16 and older. FDA has never approved a "mixed marketing" OTC approach requiring pharmacies to check customers’ ages. Carol Cox, a spokesperson for Barr, said that FDA has "given us every indication they’re willing to work with us on this proposal," adding that Barr will seek more safety data that could eventually lead to OTC status for Plan B for women of all ages.


Apparently, some senators aren't as optimistic as Ms. Cox:

Two Democratic senators plan to block a vote on President Bush's pick to head the Food and Drug Administration over the agency's stalled decision on whether to allow a "morning-after" contraceptive to be sold over the counter, one of the lawmakers said on Wednesday.

Sen. Patty Murray of Washington state said after meeting with the nominee, Lester Crawford, that he had failed to reassure her and Sen. Hillary Clinton that the agency would make a definitive decision on whether to allow sales of Barr Pharmaceuticals Inc.'s Plan B without a prescription.

"We will be putting a hold on this nomination when it goes to the (Senate) floor until a decision is reached on Plan B... any decision," Murray said. Sens. Clinton of New York and Edward Kennedy of Massachusetts also participated in the meeting.

The senators said last month during a hearing with Crawford, who is currently acting FDA commissioner, they wanted answers from him before the Republican-led Senate held a vote on his nomination.

The Senate Health Education Labor and Pensions Committee is expected to clear his nomination when it meets next week, but Murray and Clinton's hold would block a full Senate vote.

Murray said Crawford indicated the FDA was concerned about legal issues involving the drug's label and the possibility of riskier sexual behavior. "I think its because of their fear of litigation, not because they don't have the scientific data," she said of the delay.

...

"The bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer yes or no," Clinton said in a statement.

Murray added Crawford would not give the lawmakers a date for the decision. "Soon is all I heard," she said.


With all due respect to the senators involved, this is not the way to go about it. The FDA should approve Plan B based on the merits of the medical evidence, not because of some political deal/blackmail.

Bottom line: From various religious doctrines, to politicians on both sides of the isle, from neighbors, to strangers, to assorted health care professionals, and the FDA, when it comes to women's health, we can note a trend: Women are slowly, but surely being phased out of the decision process.

[On the other hand, if things go as planned, it's possible that in the near future all unbelievers in the U.S., regardless of sex, will be phased out of ... everything. Now that's gender equality for you!]

1 Comments:

At 1:47 PM, Blogger Rivki said...

With all due respect to the senators involved, this is not the way to go about it. The FDA should approve Plan B based on the merits of the medical evidence, not because of some political deal/blackmail.

Well, yeah. The FDC should approve Plan B based on the fact that it is a good drug that does what it proports to do with no dangerous side-effects. But they're not going to. The Senators are doing what they can to force a decision - since once a decision is actually made you can fight it. Nothing can be done while the drug is still being held in limbo. So long as the FDA is being held up by purely political objections I can't object to using political power to force them to make a decision. If the FDA would just do its job then politics wouldn't have to get involved, but so long as they're being swayed by the politics and not the science of a drug then I think it's perfectly appropriate for politicians on the other side of the isle to get involved.

 

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