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FOR IMMEDIATE RELEASE |
Media Inquiries: |
Thank you for coming today.
We are announcing the action we took today of sending a letter to Barr Labs concerning their application to allow Plan B to be sold over-the-counter.
I want to start by making sure everyone is clear on what this drug is. Also, it’s important that we define what the FDA has been asked by Barr Labs to address with respect to this drug.
Plan B has been referred to as emergency contraception. It contains one of the same active ingredients used in ordinary prescription birth control pills -- only in the case of Plan B – each pill contains a much higher dose and is taken in a different way.
Like ordinary birth control pills, Plan B is currently available to all women as a prescription drug. There is a second drug called Preven that is similar to Plan B. That drug is also sold with a prescription. Preven was first introduced on the market before Plan B.
The question we have been asked to address is whether Plan B should be available without a prescription on a pharmacy shelf, similar to the way other over-the-counter medicines like some cough syrups and allergy pills are sold, for women age 16 and older, and remain prescription-only for those under the age of 16.
The issues that we were asked to resolve, and the proposal
that was put forward by Barr Labs, presented us with many
difficult and novel policy and regulatory issues.
In some cases, the questions we were asked to answer were
unprecedented for this agency.
In particular:
Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case?
Can the prescription and over-the-counter version of the same drug be marketed in a single package?
In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?
These are profound regulatory decisions that cut to the heart of our work. The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs.
In fact, the answers to these questions could establish pathways that could make many more products available as over-the-counter drugs.
That could be a positive public health step, and one that I would support as the agency’s Commissioner if it means we could safely make many more effective medicines more easily available.
We believe these novel regulatory issues should be considered in an open, public process.
Rather than answering these questions in the context of a decision on a single drug, we need to have an open process to solicit public comment.
These regulatory and policy questions are too profound and cut across too many different products to be made behind closed doors.
And so today we are also announcing that we are taking the action of publishing an advance notice of proposed rulemaking to initiate an open public process to consider these important regulatory and policy questions.
This notice will speak only to the regulatory and policy issues raised by this application.
The resubmitted supplemental new drug application that the FDA was asked to review provides for a switch from prescription only status to Over the Counter status only for women ages sixteen years and older.
Plan B would remain prescription only for women under sixteen years of age.
The FDA’s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older.
What we are saying today is that the Agency is unable at this time to reach a decision on the approvability of the application because of these unresolved regulatory and policy issues that relate to the application we were asked to evaluate.
We need to resolve these policy and regulatory questions before we can reach a final decision on the underlying science that was presented to us.
FDA is both a scientific and a regulatory agency. And what we are saying today is that there are unique regulatory issues that need to be addressed before we can take a final action on the application.
We are beginning a process that will address the regulatory questions today, but we believe we can only decide these issues in an open, public process.
Through this process, all interested parties can weigh in on the questions of whether a drug may be both prescription and over the counter based on uses by different subpopulations and whether the prescription and over the counter versions of the drug may be marketed in a single package.
There is precedent for this kind of careful, public policy making inside FDA and inside many federal agencies. This action ensures that the rules that an Agency like ours sets are done so in an open fashion. These rules have lots of implications that aren’t always easy to anticipate at first blush.
Today I am making the commitment that we will work with our stakeholders to make sure that this process is expeditious and thorough.
Before I close, I want to step back and give you a little more detail on the regulatory pathway that led us to our current action.
And I want to help explain why the question of whether a drug can be sold simultaneously both over the counter and as a prescription product, in the same dosage, for the same indication, and in the same package, and with age as the only deciding criteria, is so profound.
FDA used to prohibit products from being both over the counter and prescription at the same time. They had to be one or the other. The idea was that if an active ingredient was safe and effective without a practitioner’s supervision it had to be over-the-counter. If it needed a prescription for one group of people, then it needed a prescription for all people.
That was FDA’s practice for a very long time.
In the late 1970s, FDA formed a task force to undertake a formal process to consider changing that policy, to determine whether a drug could be sold prescription and over-thecounter in different settings, for example, for different medical indications.
But ultimately, this task force rejected changing the policy, and so the policy continued. And from the 1950s until the 1980s, drugs were either only prescription or only over-thecounter.
There was no molecule that existed on the market as both a prescription drug and an over-the-counter product.
Then in the 1980s, the agency was challenged on an
application. FDA decided to allow the molecule to be sold as
a prescription product for one use and an over-the-counter
product for another.
Since then, there have been only a small number of
ingredients approved as both prescription and over-thecounter
and in these cases there was a meaningful
difference in the way the two products are used.
In the Plan B application, we are grappling not with the same question but with a different question: whether we can have the same molecule exist as both a prescription and over-thecounter product for the SAME indication?
And if FDA were to attempt to limit sale of an over-thecounter product to a particular sub population, would FDA be able to enforce such a limitation as matter of law, and could it do so as practical matter and then how?
Moreover, we are being asked to determine whether a product can be labeled for over-the-counter and prescription us and be sold in the same package.
I am committed to expediting this rule-making process, and in order to do so, I have ordered a 60-day comment period instead of the usual 90 to 120 day comment period. FDA will process and post the comments as they come in to us and finalization of this regulatory and policymaking process will be a personal priority of mine.
The action FDA took today underscores the Agency’s commitment to public health and safety.
As an agency and as its Commissioner personally, I want to say that FDA remains committed to making safe and effective contraceptive products available to women and men who choose to use them.
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