Plan B Rejection

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• RAY SUAREZ:

  There is new criticism on Capitol Hill of a controversial decision by the Food and Drug Administration to reject over-the-counter sales of an emergency contraceptive. Last week, the FDA announced it was not ready to approve a morning-after pill known as Plan B for nonprescription use. Plan B is actually two pills made of high doses of a birth control hormone, progestin. When used within 72 hours of unprotected sex, it can interfere with ovulation and prevent a fertilized egg from being implanted. Right now, it's only available by prescription.

  In December, an FDA Joint advisory committee voted 23-4 to recommend that Plan B be sold over the counter, but last week the FDA said it could not follow that recommendation because of a lack of data. On Capitol Hill yesterday, a dozen members called for the resignation of two top FDA officials, and said politics had trumped science.

  We get a closer look now at the case for and against the FDA decision. Dr. Susan Crockett is an obstetrician and gynecologist in San Antonio. She was on the advisory committee and was one of the four votes against over-the-counter use. And Dr. Tina Raine is an obstetrician and gynecologist at the University of San Francisco Medical Center. She also directs a reproductive health clinic for adolescents. And doctors, welcome.

  Dr. Crockett, that criticism that politics has trumped science — what do you think of that?

• DR. SUSAN CROCKETT:

  Well, actually, Ray, I disagree with that. I think the people within the FDA have done just the opposite, and done an extraordinarily good job of diligently looking at the science and not being swayed by political pressures.

• RAY SUAREZ:

  Did the Plan B drug regimen meet other FDA standards for approval — that it be not toxic, not addictive, do the things that it says it does?

• DR. SUSAN CROCKETT:

  Yes, you know, I think Plan B has been proven to be safe when used as recommended, and when it's given with competent medical care and advice. I think as a… from a metabolic standpoint, it actually is one of the safer drugs available. However, it does not meet all of the criteria for making sure that it is safe from a public health perspective. And I believe that there is a high potential for misuse and abuse of this drug, particularly in adolescent women. And the FDA decision was not one that negates the possibility of this medication ever coming over the counter. It simply is asking for studies to be done that show that it would be safe to use in the adolescent or developing teenager.

• RAY SUAREZ:

  Dr. Raine, did you see politics playing a hand in this FDA decision?

• DR. TINA RAINE:

  I think that's an accurate assessment. What you have to understand is this is an unprecedented action by the FDA. An acting director within the FDA overrode the advice of an independent expert panel that had reviewed reams of data and voted overwhelmingly that this product should be available to women in the United States over the counter.

  The reason this product is being advanced to be switched over the counter is because it has the potential to reduce the rates of unintended pregnancy in American women. There were approximately 3 million unintended pregnancies that occurred in the United States last year. We're talking women of all backgrounds, all ages, all races. The simple fact is, accidents happen among all women. The FDA has a mandate to act in the best interest of the public. This drug has been shown… and Dr. Crockett says so herself. There is no question that this product is safe. In fact, the FDA voted 28-0 on the safety of this product. This product is safer than Tylenol.

• RAY SUAREZ:

  Let me… before we go back to Dr. Crockett, why don't you deal with the issue over which the FDA said in its letter to Bar Laboratories was its primary problem with approval of Plan B for over-the-counter use– that it hasn't been screened and tested in younger adolescents.

• DR. TINA RAINE:

  First of all, you have to understand, most women begin having sexual activity at around the age of 17. So women under the age of 16 actually represent a really small segment of the potential population that could use this product. Teenagers are being used as a scapegoat to prevent this product from being available to women when they need it. And we know that emergency contraception needs to be used within 72 hours of an act of unprotected intercourse, and that for some women, not being able to get into a medical office to use it is going to prevent them from being able to use it.

  The comment that it's used correctly under medical advice… you don't need medical advice to take two pills. It's a very simple product to use. It's two pills. You take them. There's no potential for overdose. There's no toxicity. There are no women in which this drug is contraindicated.

• DR. SUSAN CROCKETT:

  The panel did not give a mandate that the FDA should release this drug to go over the counter for all people immediately. The FDA panel voted that, yes, this drug seemed to be safe and that the FDA should proceed through its normal procedures for having the drug company develop a plan for marketing this. That is completely different than giving a mandate that as the plan exists right now, it should go over the counter.

  Second of all, teenagers are very vulnerable to this marketing ploy. This medication only needs to be taken at the time of the month when a woman is vulnerable to being pregnant, and that is at the time of ovulation. It is one or two days out of a 28-day cycle. And this company is marketing this drug to be over the counter for people to be taking it whenever they can, as many times as they may need to. And there is a real concern that this is going to be exposing our teenagers to more STDs because they'll be tempted to use it instead of condoms, which are preventing their STDs. It will be keeping them from getting the medical attention that they would now need to go and get if they had a crisis with a potential pregnancy.

  And what you're advocating is removing my patients from me as a physician. You are advocating taking this medication and putting it over the counter. That physician-patient relationship makes sure that that patient gets advice, gets counseling, gets education, gets STD testing, gets a medical home, and gets all the other things that she requires. And by taking this medication, which I may add, is the first of its kind to be considered to go over the counter, you are taking hormonal contraceptives, high-dose oral contraceptives out of the place of the medical profession prescription, which is where they are and where they need to belong in.

• DR. TINA RAINE:

  No one is advocating that we somehow interfere with the patient-doctor relationship. I'm also a physician. I have worked in practice for over ten years. I've taken calls from women on weekend nights who are vacationing in Cape Cod because they've had an accident and need emergency contraception. At the time that an accident occurs, a woman doesn't need to go in and see a doctor, expose herself to embarrassment and scrutiny. What she needs is to take those pills and potentially prevent an unwanted pregnancy. That's what a woman needs. And a woman can make that decision on her own.

  And I would be the first person to say, sure, it is great to have individuals in clinics doing counseling, but at that moment when an accident occurs, what they need is emergency contraception. And what we're proposing by limiting access to doctors' offices, we know that the drug is more effective the sooner it is administered. The sooner a woman takes it, the more effective it is. By not making access… by not increasing access, we're essentially creating more opportunities for unintended pregnancies to occur.

• RAY SUAREZ:

  Dr. Crockett, in the letter that the FDA sent to Bar Laboratories, the non-approval letter, it said, "Before this application can be approved, you would have to provide data demonstrating that Plan B can be used safely by women under 16 years of age without professional supervision of a practitioner." Now, you've talked about several reasons why this idea gives you problems. They're behavioral and social as well as medical. If they designed a test that just showed that it wasn't harmful in a physical sense to women, would that be enough to clear your bar?

• DR. SUSAN CROCKETT:

  You know, Ray, I think that is an excellent suggestion, but I will tell you why that is difficult to do. In order for drugs to be tested on young, developing women, such as our adolescent women, there needs to be an approval process for it to be… for the experiment to go forth. Most of our research communities have boards called institutional review boards that make sure that an experiment, particularly one that involves hormones or medications on a developing child or an adolescent, make sure that they're safe. What this company is advocating or trying to do is make our public an experiment, in other words, present this drug to our public and see what happens. There is… that is not acceptable. And the FDA's job is to make sure that the safety and efficacy of a drug are established before it goes on the market.

• DR. TINA RAINE:

  We all understand that no drug is safe for every person, that the FDA has to consider the interests of the general public, and the data that was presented was on the general public. It included women under… it included teenagers, as well. The thing that you have to understand also, too, is this product is available without a prescription in many countries in the United… I mean, in many countries other than the United States. The United States is actually behind the rest of the world in offering…

• DR. SUSAN CROCKETT:

  Absolutely not.

• DR. TINA RAINE:

  …This potentially important product to women. Teenagers are being used as a scapegoat. The data… there is truckloads of data demonstrating its safety.

• RAY SUAREZ:

  Dr. Raine, Dr. Crockett, thanks for being with us.