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FDA Hears Arguments over Birth Control PillsAired June 29, 2000 - 1:18 p.m. ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
NATALIE ALLEN, CNN ANCHOR: Also in Washington, it's day two of FDA hearings on whether some prescription drugs should be available over-the-counter.
CNN medical correspondent Holly Firfer looks at who wins, and who loses, if one particular medication becomes easier to get.
HOLLY FIRFER, CNN MEDICAL CORRESPONDENT (voice-over): Whitney Perkins is one of nearly 500 million women around the world who have used birth control pills, the second most common form of birth control after tubal sterilization.
In countries like Japan and the Philippines, all you have to do is grab a pack from the store shelves. Although 99 percent effective and relatively safe, the pill is available by prescription only in the U.S.
DR. ROBERT DELAP, FDA: We are concerned that products that are available in the OTC market have a very strong track record of safety.
FIRFER: Gynecologist Dr. Robert Hatcher has been studying the pill since its development and says: Over 40 years of use has shown it to be perfectly safe over-the-counter.
DR. ROBERT HATCHER, EMORY UNIVERSITY, BIRTH CONTROL EXPERT, GYNECOLOGIST: Women would have greater access to them. They could get them privately, they could get them without going through a formal medical care system, which can be embarrassing and costly.
FIRFER: But the fact that birth control pills are hormones means there are potentially harmful side-effects, like heart disease and stroke, especially for women over the age of 35 who smoke. And they can be ineffective if they're not taken properly: same time every day and in the right dosage.
WHITNEY PERKINS: Thrombosis, if you take antibiotics you can -- and you're on the birth control pill, they are less effective, dryness, weight gain.
FIRFER: Whitney's doctor talked to her about potential side- effects, but some fear if the pill becomes over-the-counter, women will not see a doctor regularly for that information, or to get pap smears and pelvic exams.
HATCHER: It would be important for us at that point to come up with much better information in our package inserts to provide people good information about what to watch out for about oral contraceptives.
ALLEN: Holly joins us now.
Holly, if birth control pills were allowed over the counter, what would it do to the cost?
FIRFER: Well, for many drugs that go from prescription to over- the-counter, obviously the price drops. It does, there's a lot of competition in the marketplace and if the price for over-the-counter birth control pills were to drop, that would mean less money for the pharmaceutical companies. And even doctors would feel the pinch, less people going to doctor's office visits to get that prescription. So it definitely is a financial issue. People are looking at what it would do to the cost and what it would do for them.
ALLEN: There's an alternative here, not exactly to go over-the- counter, but "under-the-counter," what does that mean?
FIRFER: Well, basically, you could still get these pills without a prescription. But what they might do is put them behind the counter with the pharmacist, so that you wouldn't just grab it off the shelf. You would have to ask the pharmacist for the birth control pill. That way, he could make sure, he could tell you about the side effects, he could tell what to look out for and make sure that you know exactly how to take them properly; so they are safe and effective. So that is another alternative.
ALLEN: And has the FDA said when it's going to make a decision?
FIRFER: Not yet, what's happening now, this is a public hearing, they're listening to people talking, anybody, it could be the advocate groups, it could be your neighbor. Anybody could come up and give five minutes or less, a speech on why they think they want birth control pills either over-the-counter or by prescription only. The FDA takes it into advisement.
They also gather scientific evidence from doctors, from pharmaceutical companies, along this way, when they will take all that information together and then make a decision somewhere down the road. We're not sure exactly when but it'll be sometime before they actually decide what they are going to do. This is just sort of to get a feel of what the public wants.
ALLEN: All right, Holly Firfer, thanks Holly.
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