From: no-reply@erulemaking.net Sent: Wednesday, October 12, 2005 12:00 PM To: Dockets, FDA Subject: Public Submission Please Do Not Reply This Email. Public Comments on 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:======== Title: 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 FR Document Number: 05-17390 Legacy Document ID: RIN: Publish Date: 09/01/2005 00:00:00 Submitter Info: First Name: Melissa Last Name: Plotkin Category: Health Professional - A0005 Organization Name: Planned Parenthood of Central PA (PPCP) Comment Info: ================= General Comment:Re: Docket No. 2005N-0345 / RIN 0910-AF72 To Acting Commissioner von Eschenbach: I am writing to formally respond to the FDA?s request for public comment on whether to initiate a rulemaking process regarding the issues the Agency claims are raised by the application to make the emergency contraception (EC) drug Plan B? available over the counter (OTC). A decision on the Plan B? OTC application is long overdue, and the attempt to hand this process over to rulemaking is simply another delay tactic. The FDA is seeking public comment on issues that are not legitimate concerns with respect to the Plan B? OTC application and politics is trumping science at the FDA. For these reasons, I suggest that a rulemaking not be initiated and instead strongly urge the FDA to approve Plan B? for over-the-counter use without further delay. Despite the recommendations of the FDA?s advisory committees, the support of major professional medical associations, overwhelming scientific evidence supporting the move, and, most recently, the FDA?s conclusions that the available scientific data are sufficient to support safe use of Plan B? as an OTC product, the FDA has refused to make a decision on the Plan B? OTC application at every possible turn. These delay tactics are a major public health setback that put women?s health and lives on the line. Americans deserve an independent FDA that will protect the public health and make decisions based on science and medicine, not politics. Every day that the FDA delays making a decision on increasing access to this second chance prevention medication, more women are put at risk of facing an unintended pregnancy. Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B? is a safe, effective, and easy to use contraceptive option that helps reduce the need for abortion. The simple fact is that EC has been found to be safe and effective for over-the-counter use. Even the experts on the FDA?s own advisory committees agreed, by a unanimous vote of 28-0, that the data demonstrate that Plan B? is safe for use in the non-prescription setting. Requiring any woman to obtain a prescription for EC is not only medically unjustified, but presents a significant barrier in gaining access to this time-sensitive medication. Women in this country deserve the same unencumbered access to EC that women in 39 other countries around the world already enjoy. More than 70 of our nation?s leading medical and public health organizations ? including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Society for Adolescent Medicine, and the American Public Health Association ? support unrestricted over-the counter access to EC and agree that doing so would improve public health. Despite the unequivocal support that over-the-counter access to EC has garnered, the FDA has decided to ignore the science and use delay tactics to avoid ruling on the application. In response to the manufacturer?s original Plan B? OTC application, the FDA declared that the application was ?not approvable,? citing concerns about use in the under 16 population. These specious claims about teens and EC lack scientific merit. Study after study shows that EC is safe for younger women and that they use it responsibly. Access to EC does not increase or encourage sexual activity among teens; in fact, teens provided with advance provision of EC report increased condom use, fewer pregnancies, and no increase in sexually transmitted infections. Moreover, an overwhelming majority of the experts on the FDA?s advisory committees agreed that restricting Plan B? for teenagers would compromise their health and well being by denying them a second chance to prevent an unintended pregnancy. Instead of fulfilling its obligation to improve public health, the FDA, guided by misinformation and inflammatory rhetoric, has found ways to maneuver around the overwhelming consensus of an independent medical and scientific review process and obstruct increased access to a safe and effective medication. Dr. John Jenkins, Director of the Office of New Drugs at the FDA, stated that ?the data submitted by the sponsor in support of non-prescription use of Plan B? are fully consistent with the Agency?s usual standards for meeting the criteria for determining that a product is appropriate for such use? and that the agency had not previously distinguished the safety and efficacy of birth control among different ages. We believe, as Dr. Jenkins does, that the ?available data clearly support a conclusion that Plan B? meets the statutory and regulatory requirements for availability without a prescription for all age groups.? Dr. Jenkins goes on to say that ?such a conclusion is consistent with how the Agency has made determinations for other OTC products, including other forms of contraception available without a prescription.? When the FDA?s own leadership acknowledges that Plan B has been treated differently, it is time for the FDA to take a step back, assess the situation, and commit to moving towards restoring credibility and public trust. As the new Acting Commissioner, you have the opportunity to set the FDA back on the right track by following the science. Science tells us that Plan B? should be made available to women of all ages without a prescription. Turning this process over to rulemaking has fully exposed the fact that what started off as scientific inquiry has only become a question of politics. The public wants a reason to be proud of the FDA. It is time for the FDA to stop playing politics with women?s lives and return to the days where an obligation to protect the public health was taken seriously. The time has come to restore public confidence in the FDA and to approve the Plan B? OTC application so that women of all ages can have access to EC without delay. Sincerely, Melissa Plotkin, Director of Public Affairs, PPCP