|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 :||EC1458|
|Submitter :||Ms. Janet Goldstein||Date & Time:||10/28/2005 03:10:12|
|Organization :||Ms. Janet Goldstein|
|Category :||Individual Consumer|
| 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?|
| he 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. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?|
| 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.|
| 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.|