HHS Overrules FDA, Will Not Make Morning After Pill an Over-the-Counter Drug
Though the FDA supported it, the Department of Health and Human Services decided against allowing young teens access to the morning after pill in over-the-counter drugstores without a prescription. Though birth control is now available for free from doctors for anyone with health insurance, women under 17 facing an unplanned pregnancy will still have to consult a doctor before getting the morning after pill. Current law states that women over the age of 17, if they show ID to a pharmacist, can access the morning after pill without a prescription.
The announcement surprised even HHS staffers:
The nation’s health secretary says young teenagers cannot buy the Plan B morning-after pill without a prescription — a surprise move overruling her own experts, who were preparing to let it be sold on drugstore shelves like condoms.
Here’s HHS Secretary Kathleen Sebelius’ statement. In it, she says that, while the science shows that the morning after pill is both “safe and effective with appropriate use,” she cautioned against allowing its free usage over the counter:
The switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
What are we talking about with “using the product appropriately?” As far as I know, it involves taking one pill and then another an hour later. No chemistry is involved in the application of Plan B. Major medical associations have called for over-the-counter use since 2000. And there’s a pretty good reason: use of Plan B is time-sensitive, and often doctors are unavailable for prescription-writing when women need to use the drug. Furthermore, minors are often in situations where they have nobody to turn to for help after becoming impregnated. All this announcement will do is lead to more abortions.
Jessica Valenti wrote a couple days ago that all indications pointed to HHS approving the switch. Previous policy on the morning after pill favored ideology over sound science. I don’t see this announcement moving away from that approach.
UPDATE: Rob Stein has a lot more. FDA confirmed that they approved OTC use of Plan B, and that Sebelius, in what clearly looks like a political decision, overruled them.
UPDATE II: More fallout. According to Jodi Jacobson, an HHS secretary has never overruled an FDA decision like this before. Sarah Posner also has a good take.
HHS Overrules FDA, Will Not Make Morning After Pill an Over-the-Counter Drug
Though the FDA supported it, the Department of Health and Human Services decided against allowing young teens access to the morning after pill in over-the-counter drugstores without a prescription. Though birth control is now available for free from doctors for anyone with health insurance, women under 17 facing an unplanned pregnancy will still have to consult a doctor before getting the morning after pill. Current law states that women over the age of 17, if they show ID to a pharmacist, can access the morning after pill without a prescription.
The announcement surprised even HHS staffers:
The nation’s health secretary says young teenagers cannot buy the Plan B morning-after pill without a prescription — a surprise move overruling her own experts, who were preparing to let it be sold on drugstore shelves like condoms.
Here’s HHS Secretary Kathleen Sebelius’ statement. In it, she says that, while the science shows that the morning after pill is both “safe and effective with appropriate use,” she cautioned against allowing its free usage over the counter:
The switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
What are we talking about with “using the product appropriately?” As far as I know, it involves taking one pill and then another an hour later. No chemistry is involved in the application of Plan B. Major medical associations have called for over-the-counter use since 2000. And there’s a pretty good reason: use of Plan B is time-sensitive, and often doctors are unavailable for prescription-writing when women need to use the drug. Furthermore, minors are often in situations where they have nobody to turn to for help after becoming impregnated. All this announcement will do is lead to more abortions.
Jessica Valenti wrote a couple days ago that all indications pointed to HHS approving the switch. Previous policy on the morning after pill favored ideology over sound science. I don’t see this announcement moving away from that approach.
UPDATE: Rob Stein has a lot more. FDA confirmed that they approved OTC use of Plan B, and that Sebelius, in what clearly looks like a political decision, overruled them.
UPDATE II: More fallout. According to Jodi Jacobson, an HHS secretary has never overruled an FDA decision like this before. Sarah Posner also has a good take.
