FDA Approves Plan B Contraceptive Pill Without Prescription
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JEFFREY BROWN: The Plan B contraceptive is designed to be taken within 72 hours after unprotected sex, thus its popular name, the morning-after pill.
The pills, manufactured by Barr Pharmaceuticals, are a concentrated dose of the hormone used in regular birth-control pills and have been shown to lower the risk of pregnancy by up to 89 percent. Plan B was approved for prescription use in 1999, but a push to make it more widely available has been highly contentious, including within the Food and Drug Administration itself.
Top officials there overruled an opinion by staff scientists that non-prescription sales of Plan B would be safe for all ages. Later, several Democratic senators refused to move ahead with the confirmation of the Bush administration’s nomination of Andrew von Eschenbach as new FDA chief.
Things changed last month when von Eschenbach, on the eve of a hearing, said the FDA would consider over-the-counter sales of Plan B. And today, the agency gave formal approval, but with important limits.
Here to tell us about it is Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. He’s played a key role throughout the decision-making process. Welcome to you.
DR. STEVEN GALSON, FDA’s Center for Drug Evaluation and Research: Good to be here.
JEFFREY BROWN: Why, after all this contentious delay and this fight, have you now approved Plan B?
DR. STEVEN GALSON: The Food, Drug and Cosmetic Act requires us to make a certain assessment of the strength of the scientific information before approving a switch of a drug from a prescription status to the over-the-counter status.
We have to demonstrate — the companies have to demonstrate and we have to judge whether the drug can be taken by someone without the intervention of a physician, whether they can follow the instructions and take it the way that it’s supposed to be taken and it ends up being safe and effective.
JEFFREY BROWN: Now, the key distinction you have drawn is this age?
DR. STEVEN GALSON: That’s right.
JEFFREY BROWN: Why approve it only for those 18 and over?
DR. STEVEN GALSON: Right. We were concerned that, when we saw the information that came into us having to do with the tests on the drug about whether people could use it correctly without prescription, that there wasn’t enough data demonstrating that young people could follow those instructions. I think that the pediatric and adolescent age group is a separate entity.
They require separate, different, perhaps, types of information to show that adolescents can take the drug without the intervention of a physician as opposed to adults. They behave differently, and it seemed intuitive to me.
JEFFREY BROWN: All right. So, before we go back to that, though, tell us how it will work, as proposed now.
DR. STEVEN GALSON: Right. How it will work is, if a woman 18 and above wants the drug, she'll go to a drugstore, go up to the pharmacy desk, and ask for it. The pharmacist will ask for a government-issued identification of age, and she'll get the product.
If someone lower than age 18 comes to the pharmacist, the pharmacist will ask for proof of age. And if they're lower than 18, they'll need a prescription to get the drug.
JEFFREY BROWN: OK, so, as you know and as we said, there have been a number of findings that Plan B is safe and effective for all ages, including your own advisory group which you rejected.
DR. STEVEN GALSON: Right, yes.
JEFFREY BROWN: Now, just to be clear, did you reject it on health or on scientific and medical grounds, on behavioral grounds, on what?
DR. STEVEN GALSON: Yes, it's difficult to distinguish health, scientific, behavioral. Definitely on scientific grounds. And it's important to point out, as well, that the advisory committee wasn't unanimous. There were concerns on the part of some members of the advisory committee that there was not enough data or that there were issues that remained in the younger age group. It was definitely scientific.
JEFFREY BROWN: One of the outspoken people on this, Susan Wood, a former FDA assistant commissioner for women's health, resigned over the Plan B decision. She said today, "While I am glad that the drumbeat for a return to science-based FDA has had some positive impact, this decision still represents a compromise, one that could have the unintended consequence of hurting young women's health."
Now, two parts to that criticism. One is that, for the last several years, you have been pursuing a political rather than scientific agenda on Plan B. How do you respond?
DR. STEVEN GALSON: I'm a career physician in the public health service, not involved in politics, don't get involved in those sort of discussions. And the Food, Drug and Cosmetic Act requires us to use scientific criteria, health-based criteria to look at the law, to look at the administrative practicalities of compliance, and how drugs can be used out there in the U.S. Politics just haven't been part of my assessment.
JEFFREY BROWN: But you have to know the political debate is out there. So you're saying that political ideology or influence played no role?
DR. STEVEN GALSON: Not in my assessment, and not in my decision-making.
JEFFREY BROWN: The second part of that critique would be that this is a compromise, that that still could harm young woman, especially those below 18 who might be the ones most in need of the pill.
DR. STEVEN GALSON: Yes. There's always controversy about drug regulation.
There's particularly always controversy about drugs having to do with human
reproduction. And I'm not at all surprised that there are people on both sides of this debate. People will see it as a compromise. I see it as us looking at the data that
was available to the agency, was provided to the agency, and doing what Congress, through the statute, asked us to do in analyzing the data and finding an approval route that made sense based on the information that we have.
JEFFREY BROWN: But when you said earlier that young people were clearly a different category, why exactly, when it comes to this particular?
DR. STEVEN GALSON: We protect young people in special ways in lots of realms in society. After all, we don't sell them alcohol. They have special graduated licensing requirements. And that's because we believe that there are different risk-taking behaviors on the part of children. My view is that this applies to pharmaceutical products, as well. We have to really understand whether adolescents and children can go into the drugstore and undergo the same sort of decision-making about risk and benefit that adults can.
JEFFREY BROWN: Now, the other limit that's notable here is on where this would be...
DR. STEVEN GALSON: Right.
JEFFREY BROWN: ... available. Only in drugstores, only behind the counter, not in convenience stores, for example.
DR. STEVEN GALSON: Convenience stores, gas stations.
JEFFREY BROWN: Why? Why not?
DR. STEVEN GALSON: We wanted to be very attentive to the fact that we're implementing a program that requires the intervention, the skills, the education and training of a pharmacist. We want a pharmacist to look the patient in the eye and make sure that they fit in the categories -- the age category. So it's just we didn't think this was practical or possible. Of course, there aren't pharmacists in convenience stores, and that's why we really required it only to happen in pharmacies.
JEFFREY BROWN: Some social conservative groups lobbied against the approval for quite a while. Today, Wendy Wright, president of Concerned Women for America, said in a statement, "If the FDA thinks that enacting an age restriction will work or that the drug company will enforce it when it has already announced it has no intention of enforcing it, then they are living in a dream world."
Again, two parts to that. First of all, what is Barr, the company, going to do? What have you asked them to do? And what have they agreed to do, in terms of enforcing this?
DR. STEVEN GALSON: Right. First of all, let me just point out that age restrictions do work. They work with alcohol. They work with tobacco. Of course people get through the net. But I expect that pharmacists, as professionals, they're licensed by states, they're going to take this very seriously. It's illegal to give a drug, prescription drug to someone who has not received a prescription for that drug. And I'm completely convinced that we'll be able to implement this.
What Barr is going to do with us looking over their shoulder and with state pharmacy boards looking over their shoulder, as well, is monitor the use of this product, do surveys that will enable us to look at how the product is being prescribed and used. In addition, they're actually going to send people into pharmacies to purchase the product and make sure that the pharmacists are following the rules that have been set up in providing the drug to the proper age categories.
If there are problems with this program, they'll be reported to us, they'll be reported to the state boards of pharmacies, and we'll consider making changes in the program.
JEFFREY BROWN: One of the arguments continually made by social conservative
groups was that making this available to women might give them a false sense of
security and might lead to more sexual promiscuity. Do you believe that the availability of Plan B will change sexual behavior?
DR. STEVEN GALSON: You're asking a complicated question having to do with promiscuity and sexual behavior. There are parts of sexual behavior, such as use of other kinds of contraception's like condoms, that aren't necessarily related to promiscuity. The assessment of promiscuity was not part of our assessment.
We don't have regulatory jurisdiction over that part of sexual behavior. We did look at concomitant use as of other forms of birth control, such as condoms, because, from a public health perspective, it's very, very important because condoms decrease transmission of sexually transmitted diseases, including HIV. So we did look at that; that was important. But the promiscuity part we don't regulate and wasn't part of the assessment.
JEFFREY BROWN: So the sexual behavior part -- when you're talking about younger people as a different category, is that part of your thinking, that the sexual behavior might be affected by making it available?
DR. STEVEN GALSON: Behavior to me, when ask you that question, includes use of other forms of birth control, such as condoms. That part we did consider; the promiscuity part of it we didn't consider.
JEFFREY BROWN: Do you expect now that there will be a sharp increase in the use of the drug?
DR. STEVEN GALSON: I expect there will be. There has been since the discussion hit the media and became public about Plan B back in 2004. One of the issues with emergency contraception is people didn't even know that it exists. They're confused about it; they don't know what it is; they don't know where to get it. So I expect it will increase. I'm not sure how dramatically.
JEFFREY BROWN: And, finally, I noted that Bruce Downey, the chairman of Barr Pharmaceuticals, today pleased with part of your decision, but said that the company will continue to push for broader availability. Might that be revisited, or is this over now?
DR. STEVEN GALSON: If we get a request from the company with more data to look at this question again, you know, we'll, of course, look at it. I look forward personally to getting involved in investigating some of the scientific questions that have been raised in this review, in this assessment and controversy about how adolescents and young people use over-the-counter drugs. I think it's something that we have to pursue at FDA.
JEFFREY BROWN: All right. Dr. Steven Galson of the FDA, thank you very much.
DR. STEVEN GALSON: Thank you very much.