District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women
NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma’s behalf in extending patent exclusivity for Plan B One-Step.
Korman is the same district judge who in 2009 ruled that the decision whether to make Plan B One-Step available without a prescription regardless of age "was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge." Instead he ruled, at the time, that the FDA reconsider a Citizen’s Petition to make Plan B available to women of all ages.
Three years later, FDA commissioner Margaret Hamburg issued a statement supporting Plan B One-Step availability to all ages, however ruling was subsequently overruled by Department of Health and Human Services Secretary Kathleen Sebelius. "The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious and unreasonable," Korman ruled in his 59-page decision.
"The standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug ‘safely and effectively,’" he wrote. "I decide this case based only on my understanding of the applicable standard."
In his second ruling, Korman ruled the district court did not have jurisdiction to compel the agency. "I have no power to grant a period of exclusivity," he noted. "Indeed, I do not have subject matter jurisdiction to review the denial of Teva’s NDA for the purpose of granting it any relief, much less granting a period of exclusivity that only the FDA can grant when it approves an application after finding that the studies submitted by the sponsor are essential. Under these circumstances, intervention would be pointless."
The ruling to expand availability to women under the age of 17 also potentially applies to Plan B and the generic equivalent levonorgestrel, though the judge allowed for the FDA to determine whether to restrict the decision to Plan B One-Step. "If the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product," Korman ruled.
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Boehringer-Ingelheim helps sponsor Walgreens team for St. Louis colon cancer run
ST. LOUIS — More than 90 runners signed on to join Team Walgreens/Team Tori last month at the 2013 St. Louis Undy 5000 in support of 24-year old Tori Riley. The team raised more than $1,000 in support, half contributed to the Colon Cancer Alliance and the other half to Team Tori, through T-shirt sales, raffles for Walgreens beauty bags and silent auctions that included St. Louis Cardinals tickets, among other items.
"Last year was the first year that [Team Walgreens/Team Tori] participated in the Undy 5000, so this year we wanted to have a greater impact," commented team captain Stefani Cheseldine, an operations trainer for Walgreens. "We are setting a goal for next year to be the biggest team at the St. Louis Undy 5000."
Two days before the Undy 5000 event, Tori’s mother announced her daughter had gotten engaged and continues to be upbeat in her fight against colon cancer. For more information on Team Tori, click here.
Boehringer-Ingelheim helped sponsor Team Walgreens/Team Tori this year. BI is a regular sponsor of Undy 5000 events under its Dulcolax brand.
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Study shows 75% of teens report increased knowledge from prescription drug prevention program
ORLANDO, Fla. — According to an independent research firm, a recent pilot program to address awareness of the dangers of prescription drug abuse in teens showed 75% of all respondents were more aware of the dangers of misusing and abusing prescription drugs after participating in the educational program.
Wake Up!, established by The Pain Truth, a Florida 501(c)(3), was implemented into five pilot schools, thanks in part to a grant from Millennium Laboratories, three in San Diego, CA, and two in Tampa Bay, FL. The objective of the in-school prescription drug educational program is to raise awareness, increase knowledge, and change perceptions concerning the misuse and abuse of controlled prescription medications among high school students, providing students with knowledge to make better decisions and prevent first use. Wake Up! uses multi-media, social marketing and other tactics that are familiar and appealing to teens, but Wake Up! program developers believe the real motivating force is the science-based facts presented to the students.
According to the U.S Office of National Drug Control Policy, most teens initially get prescription pills from family and friends, including straight from home medicine cabinets. Prescription drug abuse has become an epidemic in the United States. More than one-third of those abusing prescription drugs in the U.S. are between the ages of 12-17. Deaths from prescription drug overdoses have become the second leading cause of accidental deaths nationwide, and the leading cause in as many as 15 states, according to the U.S. Drug Enforcement Administration.
Additional findings from the survey demonstrate that nearly half of students believe that the program would change the behavior of their peers. After being exposed to Wake Up!, attitudes and behaviors concerning prescription drugs changed, with between 30 percent and 40 percent of students expressing more concern about friend’s or family member’s drug use, and reported that they were more likely to tell a parent, teacher, doctor or other trusted adult about their own or others’ drug use. Additionally, over 90 percent of teens surveyed now understand that people are at risk of harming themselves if they use prescription drugs not prescribed to them.
"The results of the study are overwhelmingly positive and clearly indicate the Wake Up! campaign can have tremendous, beneficial outcomes," says Lora Brown , MD, a board certified pain management physician and medical director for Wake Up!. "Our team is looking forward to the future, and all that we can do in schools and communities across the country with Wake Up! takeovers, and sustainability through our CORE Ambassador student teams that we leave behind and continue to work with after the initial campaign."
Wake Up! has been invited to present the campaign and new research results at the Native American Youth Forum — Drug Abuse Education for a Community Response taking place April 5 at Pala Resort, northeast of San Diego, and the 2013 Clinton Global Initiative University event at Washington University in St. Louis.