Chicago Tribune Editorial - Plan B for the FDA
Chicago Tribune Editorial - Plan B for the FDA
Copyright © 2006, Chicago Tribune
Published August 4, 2006
Is the Food and Drug Administration really serious about approving Plan B, the "morning-after pill," for over-the-counter sales? Maybe. FDA officials sure surprised a lot of people--including, apparently, the drugmaker, Barr Pharmaceuticals Inc.--by springing a sudden decision to talk to the company in the next week. After years of ignoring its own scientific experts and delaying the contraceptive drug's move to over the counter, the FDA said in a statement that it hoped to agree on an approval process "in a matter of weeks" if the talks go well.
No, the timing of this--one day before Senate confirmation hearings for a new FDA head--wasn't coincidental.
The nominee, Dr. Andrew von Eschenbach, the acting FDA commissioner, faced tough questions before the Senate on Tuesday. He pledged that under his leadership the agency would be guided by "sound science" and that he was "committed to maintaining the long-standing traditions and values" of the FDA.
If so, his first order of business should be to end this shameful chapter in FDA history and grant the approval for over-the-counter sales of Plan B. The evidence is overwhelming that the morning-after pill is safe and effective.
The FDA's dawdling and delay over the Plan B proposal for more than two years has been unconscionable. It had argued that science alone, not politics, accounted for its reluctance to approve the pill for over-the-counter sale. That argument was demolished last year by the Government Accountability Office. A GAO report led to one conclusion: Top FDA officials bigfooted the decision in 2004 to deny over-the-counter sales of the pill. Politics, not science, dictated the final outcome.
Politics, not science, will also dictate whether von Eschenbach is confirmed as the next FDA chief. Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) vow to block a vote on his nomination until the FDA acts on Plan B. And this time, unlike last year, they say they won't be swayed by empty FDA promises to settle the issue. Last year, the senators got fleeced when then-FDA Commissioner Lester Crawford told them he planned to make a decision by Sept. 1 on allowing Plan B to be sold over the counter. But then Crawford "decided" not to decide, opting instead for further study.
President Bush could circumvent the Senate vote on von Eschenbach with a recess appointment. So stay tuned.
FDA approval for over-the-counter sales is not assured. One potential hurdle: the FDA wants the company to ensure that pharmacies won't sell the pill over the counter to girls younger than age 18. But isn't that the pharmacies' responsibility? Some advocates worry that such an onerous requirement could be a loophole that would allow the FDA to deny permission for over-the-counter sales.
Dr. Susan Wood, former director of the FDA's Office of Women's Health, resigned in protest last August after the last Plan B delay. She said she was "somewhat encouraged" by Monday's announcement. But she also warned: "I feel they're making it appear they're moving forward. But until we actually see a decision, we can't count on that." Yes, some skepticism is warranted here. Unfortunately, politics may yet trump science again.
Copyright © 2006, Chicago Tribune
Published August 4, 2006
Is the Food and Drug Administration really serious about approving Plan B, the "morning-after pill," for over-the-counter sales? Maybe. FDA officials sure surprised a lot of people--including, apparently, the drugmaker, Barr Pharmaceuticals Inc.--by springing a sudden decision to talk to the company in the next week. After years of ignoring its own scientific experts and delaying the contraceptive drug's move to over the counter, the FDA said in a statement that it hoped to agree on an approval process "in a matter of weeks" if the talks go well.
No, the timing of this--one day before Senate confirmation hearings for a new FDA head--wasn't coincidental.
The nominee, Dr. Andrew von Eschenbach, the acting FDA commissioner, faced tough questions before the Senate on Tuesday. He pledged that under his leadership the agency would be guided by "sound science" and that he was "committed to maintaining the long-standing traditions and values" of the FDA.
If so, his first order of business should be to end this shameful chapter in FDA history and grant the approval for over-the-counter sales of Plan B. The evidence is overwhelming that the morning-after pill is safe and effective.
The FDA's dawdling and delay over the Plan B proposal for more than two years has been unconscionable. It had argued that science alone, not politics, accounted for its reluctance to approve the pill for over-the-counter sale. That argument was demolished last year by the Government Accountability Office. A GAO report led to one conclusion: Top FDA officials bigfooted the decision in 2004 to deny over-the-counter sales of the pill. Politics, not science, dictated the final outcome.
Politics, not science, will also dictate whether von Eschenbach is confirmed as the next FDA chief. Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) vow to block a vote on his nomination until the FDA acts on Plan B. And this time, unlike last year, they say they won't be swayed by empty FDA promises to settle the issue. Last year, the senators got fleeced when then-FDA Commissioner Lester Crawford told them he planned to make a decision by Sept. 1 on allowing Plan B to be sold over the counter. But then Crawford "decided" not to decide, opting instead for further study.
President Bush could circumvent the Senate vote on von Eschenbach with a recess appointment. So stay tuned.
FDA approval for over-the-counter sales is not assured. One potential hurdle: the FDA wants the company to ensure that pharmacies won't sell the pill over the counter to girls younger than age 18. But isn't that the pharmacies' responsibility? Some advocates worry that such an onerous requirement could be a loophole that would allow the FDA to deny permission for over-the-counter sales.
Dr. Susan Wood, former director of the FDA's Office of Women's Health, resigned in protest last August after the last Plan B delay. She said she was "somewhat encouraged" by Monday's announcement. But she also warned: "I feel they're making it appear they're moving forward. But until we actually see a decision, we can't count on that." Yes, some skepticism is warranted here. Unfortunately, politics may yet trump science again.
posted by Carlos T Mock at 10:33 AM
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