2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC1624
Submitter : Ms. L H Romano, Esq. Date & Time: 10/31/2005 01:10:56
Organization : Ms. L H Romano, Esq.
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
This is an almost redundant question vis-a-vis the one below. Since I assume that you are referring to ? 503(b) of the act (and not the action) and that you prefer proper verb forms to improper ones, you can find my response immediately below.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
The Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval.

More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies.

When the age restriction was suggested at the December Advisory Committee meetings, the FDA staff noted then that it has been the policy of the Division of Reproductive and Urologic Drug Products to make no distinction between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. The Advisory Committee members then rejected the age restriction proposal.

The apparent move by the agency to restrict access to young women, 16 years of age and younger, therefore flies in the face of the recommendations of the majority of respected medical professional associations and the government's own stated policy.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The Food and Drug Administration's apparent intent to limit access by age has muddled what should have been a clear- cut decision to approve over-the-counter sale of this safe and effective emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with its lengthy comment and review process is being suggested only to drag out the time period before a final decision on EC - OTC is made. It is completely unnecessary.
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
We are all familiar with items that are sold only to purchasers over a certain age, including alcohol, tobacco, and the nicotine patch. However asking for identification is both burdensome and unnecessary - and is an unacceptable intrusion on personal privacy with regard to medical care. Limiting sale of emergency contraception to young women is a bad idea, and it is simply inappropriate to deny young women the means to prevent pregnancy. The FDA's job is to determine safety and efficacy, not to serve as the "morality police" on behalf of any special interest group.
B. If it could, would it be able to do so as practical matter and, if so, how?
Such a move would be intrusive for all young women who would be required to show personal identification as a proof of age. The suggestion of federal enforcement brings to mind federal agents pursuing 16 year olds concerned about an unintended pregnancy who in the act of obtaining emergency contraception are breaking a federal law. The absurdity is hard to exaggerate.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Making EC universally available would obviate the need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would not be any circumstances that would be inappropriate for a single package.
[The typical corresponding boilerplate will do just fine here.]

Because I so completely agreed with this version, I made no significant changes above. I will add my personal correspondence and thoughts, though.

Here is a letter I recently received from Target:

Dear Target Guest,

Target places a high priority on our role as a community pharmacy and our obligation to meet the needs of the patients we serve. We expect all our team members, including our pharmacists, to provide respectful service to our guests, particularly when it comes to their health care needs. ?Like many other retailers, Target has a policy that ensures a guest?s prescription for emergency contraception is filled, whether at Target or at a different pharmacy, in a timely and respectful manner. This policy meets the health care needs of our guests while respecting the diversity of our team
members. ?Your thoughts help us learn more about what our guests expect, so I?ll be sure to share your feedback with our pharmacy executives. ... I hope we?ll see you again soon at Target.?Sincerely, ?
Jennifer Hanson ?Target Executive Offices

And here is my response:

Dear Ms. Hanson,

No, because of your policy, you definitely WON'T be seeing me soon at Target! ?If I have a prescription from my doctor that I cannot get filled at Target, because some ... employee of yours thinks that he or she somehow knows better than me and my doctor about what is good for me, and if I have to go elsewhere to fill it (or even wait one minute longer than would normally be necessary to get it filled at Target), not only is that NOT providing respectful service to me, but it also disrespects what certified members of the medical community have been authorized by law to do. ?Forcing me to make an extra stop to go somewhere else to obtain a legal, valid prescription simply because your employee's misguided beliefs [URL] cause him or her to act ultra vires is, in my mind, unquestionably illegal. It is also, in practice, quite unnecessary, since, from this day forward, I'll be making my ONLY stop at a store that will fill ALL my family's prescriptions immediately and without question. It's Target that I won't be making any extra stops at until this policy is changed. ?While I can respect your supposed desire to respect the diversity of your team members and their beliefs, you seriously need to reassign them out of the pharmacy area and, if they then start trying to dictate what books and magazines, etc., they think I and your other customers ought to be reading, then you seriously need to reassign them out of your employ period. [END]

Nine years ago, my contraceptively-responsible long-married spouse and I had an extremely legitimate need for EC well before that term or its existence was even well-known. Fortunately, we received it immediately without any dweeb behind the pharmacy counter telling us that we couldn't.

Today, at age 45, and with a second trip to the "local" Target racking up 80 miles on my odometer, I am livid thinking that they (and YOU!) are now--for legitimately inexplicable reasons--trying to prevent anyone else from getting the same health care. So, factor in a 15-year-old who cannot drive like I can, who cannot even afford the cost of gas for these miles, and who also has to have the gumption, while under tremendous stress, to have to fight the dweeb at the prescription counter yet again. Under these potential (and common!) circumstances, I consider myself pretty darned lucky.

But now, for the FDA to put another unsubstantiated hurdle in front of me or anyone else in this position is not only irresponsible, it's also downright crushing. (Unless, of course, you intended this result all along?) Please don't forget that your ultimate allegiance is still to the health and welfare of the American consumer and that, for the FDA to go beyond this, would clearly be for it to be acting ultra vires itself.