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Temporary stay of Plan B decision extended through May 28

BY Michael Johnsen

NEW YORK — The Food and Drug Administration’s temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit on Monday. 

The Second Circuit will entertain the appeal on that day. 

"Although the district court rejected the government’s position in the strongest terms, the court plainly exceeded its jurisdiction in ordering FDA to take any action on the one-pill drug and to make any of these drugs available without a prescription or any other restriction without conducting a rulemaking," the appeal reads. "Because the district court plainly overstepped its authority, there is a substantial likelihood that the government will prevail in this appeal. The balance of harms and the public interest also strongly support a stay."

Senior United States District Judge Edward Korman on Friday had denied an FDA motion for a stay pending an appeal of Korman’s earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions. 

However, Korman had granted a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013." It was a deadline that the FDA honored. 

In a 17-page decision, Korman noted he was not appeased by FDA’s decision regarding Plan B One-Step. "Plan B One-Step aside, the effect of my [original] decision was to make levonorgestrel-based emergency contraceptives available without a prescription and without any point-of-sale or age restrictions," he wrote. "The only practical difference between my decision and the decision of the FDA that the Secretary reversed was that the FDA’s decision was arguably directed towards the one-pill version of the drug, and my decision applied to both versions." 

 

 

 

 

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AstraZeneca encourages asthma awareness

BY Alaric DeArment

WILMINGTON, Del. — Drug maker AstraZeneca is encouraging patients with asthma to control their disease and learn about how it may be affecting their lives as part of National Asthma and Allergy Awareness Month, which takes place in May.

"It is important for patients with asthma to gain control of their symptoms on an ongoing basis, allowing them to live their lives with fewer interruptions — asthma doesn’t have to limit their daily activities," AstraZeneca medical affairs executive Frank Trudo said. "National Asthma and Allergy Awareness Month is an opportune time for patients with asthma to work with their healthcare providers, re-examine asthma triggers and symptoms, to determine if their asthma is under control and their lungs are functioning optimally."

The drug maker noted that the disease affects about 25 million Americans and accounts for more than 3,300 deaths each year.

 

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N.J. law designed to address prescription eye drop adherence

BY Alaric DeArment

TRENTON, N.J. — New Jersey Gov. Chris Christie signed legislation into law Monday that will allow patients using prescription eye drops to get early refills in order to prevent interruptions in therapy.

The law, A-3080 — and companion Senate bill S-2166 — requires insurance companies and health plans to cover early refill of prescription eye drops when 70% of a supply’s days of use have passed. For example, a patient with a 30-day supply could obtain a refill after 21 days instead of having to wait for all 30 days. Supporters of the legislation said it was necessary due to the number of people who have difficulty properly administering prescription eye drops for chronic conditions such as glaucoma, which can result in patients missing their eyes or using too many drops.

"Many diseases of the eye are treated with chronic therapy through use of medications," New Jersey Academy of Ophthalmology president Cecily Lesko said. "Glaucoma is the most common. Left untreated, it is one of the leading causes of blindness. With this effort and outcome, proper treatment remains available to more patients who will benefit personally and directly through the treasured gift of sight."

 

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