FDA, parent agency HHS divided over emergency contraceptive prescription status
SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.
"This morning I received a memorandum from the secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," Hamburg stated. "Because of her disagreement with the FDA’s determination, the secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved."
Plan B One-Step will remain on the market with its dual prescription/nonprescription status — available from behind the pharmacy counter to women over the age of 17 years and by prescription only for women younger than 17 years.
Following a review of consumer usage studies, FDA’s Center for Drug Evaluation and Research determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
"It is our responsibility at the FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence," Hamburg stated. "CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."
"I have carefully considered FDA’s Division Director Summary Review of Regulatory Action, dated Nov. 30 2011, for the supplement application, which represents the position of the FDA and recommended approval of the application," HHS secretary Kathleen Sebelius wrote in a letter addressed to Hamburg. "Based on my view, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages."
HHS instructs FDA to decline proposal to move Plan B from BTC to OTC
WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.
"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed [the Food and Drug Administration] to issue a complete response letter denying the supplemental new drug application by Teva Women’s Health," stated HHS secretary Kathleen Sebelius.
"This application sought to make Plan B One-Step available over the counter for all girls of reproductive age," she stated. "The science has confirmed the drug to be safe and effective with appropriate use. However, 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."
The average age of the onset of menstruation for girls in the United States is 12.4 years, Sebelius noted. However, about 10% of girls are physically capable of bearing children by 11.1 years of age. "It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."
Study: Irregular work schedules may be contributing factor of diabetes in women
BOSTON — Women who work a rotating schedule that includes three or more night shifts per month, in addition to day and evening working hours in that month, may have an increased risk of developing Type 2 diabetes when compared with women who only work days or evenings, according to a new study led by researchers at Harvard’s School of Public Health that was released Tuesday.
In addition, the researchers found that extended years of rotating night shift work was associated with weight gain, which may contribute to the increased risk of Type 2 diabetes.
Previous studies have focused on the association between shift work and risk of cancer and cardiovascular disease. The HSPH study is the largest study so far to look at the link between shift work and Type 2 diabetes and the first large study to follow women. The findings were published online Dec. 6 in the open access journal PLoS Medicine.
“Long-term rotating night shift work is an important risk factor for the development of Type 2 diabetes, and this risk increases with the numbers of years working rotating shifts,” stated An Pan, research fellow in HSPH’s Department of Nutrition and the study’s lead author.
The researchers analyzed data on more than 69,269 U.S. women, ages 42 to 67 years, in the "Nurses’ Health Study I," tracked from 1988 to 2008, and 107,915 women, ages 25 to 42 years, in the "Nurses’ Health Study II," tracked from 1989 to 2007. About 60% of the nurses performed more than one year of rotating night shift work at baseline; about 11% in "Nurses’ Health Study I" had more than 10 years of rotating night shift work at baseline, and about 4% in "Nurses’ Health Study II" worked more than 10 years of rotating night shifts at baseline, and this proportion increased during the follow-up.
The researchers found that the longer women worked rotating night shifts, the greater their risk of developing Type 2 diabetes. Those women who worked rotating night shifts for three to nine years faced a 20% increased risk, women who worked nights for 10 to 19 years had a 40% rise in risk and women who worked night shifts for over 20 years were 58% more at risk. In addition, women who worked rotating night shifts gained more weight and were more likely to become obese during the follow-up.
After taking into account body weight in the analyses, the increased risk of Type 2 diabetes for women who worked rotating night shifts was reduced but remained statistically significant. For example, women who worked rotating night shifts for more than 20 years had 24% increased risk. These findings indicate that the relationship between night shift work and Type 2 diabetes is partly explained by increased weight.
While the findings need to be confirmed in men and in some ethnic groups (96% of the participants were white Caucasians) and further studies are needed to identify underlying mechanisms for the association, the results are of potential public health significance due to the large number of workers who work rotating night shifts.
According to the U.S. Centers for Disease Control and Prevention, approximately 15 million Americans work full-time on evening shifts, night shifts, rotating shifts or other irregular schedules. Shift work has been shown to disrupt sleeping patterns and other body rhythms and has been associated with obesity and metabolic syndrome, conditions associated with Type 2 diabetes.