HEALTH

Medical community commends court ruling to make Plan B One-Step available as OTC to women under 17

BY Michael Johnsen

WASHINGTON — The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society of Adolescent Health and Medicine Friday morning commended a U.S. District Court ruling that expands over-the-counter access of Plan B One-Step to women under the age of 17. "This decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age," the medical associations stated as part of a joint statement. 

“While pediatricians recommend that teens delay sexual activity until they fully understand its consequences, we strongly encourage the use of contraception—including emergency contraception—to protect the health of our adolescent patients who are sexually active," commented AAP president Thomas McInerny. 

“Removing the age restriction is a positive step forward, but providers must continue efforts to educate adolescents about the proper use of emergency contraception," added SAHM president Debra Katzman. "We must also work to ensure that emergency contraception is affordable for adolescents of limited means.”


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District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women

BY Michael Johnsen

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

BY Jason Owen

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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