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There continues to be response and fallout as a result of a congressional investigation into the FDA’s rejection of allowing the Plan B morning after pill to be sold over the counter without a prescription.
There are several issues which need to looked at more closely:
Did the FDA in fact act on political motives solely? Did the orders come from higher up? And why, when contraception is so accepted in this country, is this contraceptive pill being singled out as a problem, and in fact, being treated rather as an abortion pill, which it isn’t.
Today, consumers, health experts, the company that makes the drug Plan B, and U.S. Senator Hillary Clinton spoke out about the questionable decision.
It’s not hard to find women who feel strongly about the morning after pill issue.
“I think it’s a very misguided decision that they made,” says 47 year old Amala Lane.
At issue: this government report which found the FDA acted irregularly in rejecting the approval of the over the counter sale of the Plan B emergency contraceptive.
U.S Senator Hillary Clinton was one of the legislators who called for the investigation. “This administration doesn’t even want Plan B to be readily available after a rape occurs. So clearly ideology is trumping science that should disturb anyone,” says Clinton.
If this is true, the question is, why? Perhaps, because of a misunderstanding over what Plan B truly is.
Dr. Edward Linn, Director of Women’s Health at Rush-North Shore Medical Center in Chicago, says, “I’m not even really sure if I understand what the hubbub is about and what the controversy is in this case. It is purely a contraceptive. It does not interrupt pregnancies.”
Today at a press conference, the maker of Plan B, Barr Pharmaceuticals, sought to set the record straight.
Dr. Caron Ben-Maimon, President and COO of Duramed Research, a subsidiary of Barr, said, “We’re still hoping for an approval, we’d like to take the product over the counter, we think it’s safe and effective over the counter. But we know that will probably take a long time. So right now we’re working to bringing people attention that it’s available as a prescription.”
So, how could those at the FDA helm reject the application in spite of an overwhelming vote of support by its own advisory panel and a multitude of independent experts and organizations?
“They seem to make a decision from the very top of the agency even before the scientific process even was completed so clearly they were getting direction from above whether it was the White House or HHS or somewhere else in the administration to basically go along with political pressure,” says Clinton.
And while the Plan B issue in and of itself is a significant one, there are bigger, more looming questions which affect all Americans surrounding the activity and legitimacy of the FDA.
“Think about whether you and the drugs you need for your quality of life could be perhaps interfered with kept off the market because someone somewhere disagreed with not on a scientific basis which is what the FDA is supposed to stand for but for political or ideological reasons. So there’s another application pending to make plan be available over the counter and I’m urging the FDA to make a yes or no decision based on science not on politics,” Clinton argues.
Following the rejection of the application in May of 2004, the FDA recommended to Plan B maker Barr to resubmit an application, but this time only for women 17 and older.
Barr did just that--and there has been no decision now for months.
The reason: the FDA says it has to consider how it can make a policy selling the same drug in the same dose over the counter for one age group and by prescription for another age group. Clinton points out age policies on sales exist now with items the FDA regulates, including cigarettes and alcohol, so it should not be an issue.
The next moves: for Plan B, it’s to get a vote; this has been essentially filibustered for months now.
The bigger issue though is the FDA: Senator Clinton is calling on the president to put in place a new FDA head who has an impeccable record, and is asking that HHS secretary Michael Leavitt denounce the FDA’s decision on Plan B. However, he’s already stated he supported the decision.
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