Obama issues executive order to address drug shortages
WASHINGTON — President Barack Obama issued an executive order Monday to address the growing problem of drug shortages.
The order directs the Food and Drug Administration "to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging." Specifically, the FDA is directed to broaden reporting of potential shortages of certain prescription drugs and expand efforts to expedite review of new manufacturing sites, suppliers and manufacturing changes. The order also directs the FDA to work with the Department of Justice to find out whether wholesalers and other companies have responded to potential shortages by illegally hoarding medications or raising prices.
Other actions include plans by the administration to send a letter to drug manufacturers encouraging them to report discontinuation of certain drugs to the FDA and notify the agency of potential prescription drug shortages. It will also increase staffing resources for the FDA’s Drug Shortages Program.
"We applaud the president’s initiative in issuing this executive order and believe that through continued multi-stakeholder collaboration, we can put a stop to this problem," GPhA president and CEO Ralph Neas said. "No patient should ever be denied treatment because the needed medicine is in short supply."
Sen. Amy Klobuchar, D-Minn., and Rep. Diana DeGette, D-Colo., recently introduced legislation that would require disclosure of all prescription drug shortages and give the FDA new authority to enforce those requirements.
***This story updates the story posted Monday morning titled "Report: Obama to sign executive order to address drug shortages."
Court injunction stops Watson, Amphastar from marketing, selling Lovenox generic
PARSIPPANY, N.J. — Watson Pharmaceuticals and a partnering company are barred from launching a generic version of a blood-thinning drug under a federal court decision issued Friday.
Watson said the U.S. District Court for the District of Massachusetts issued a preliminary injunction preventing Watson and Amphastar Pharmaceuticals from marketing or setting Amphastar’s generic version of Sanofi’s Lovenox (enoxaparin sodium). The case was brought by Sandoz, the generics arm of Swiss drug maker Novartis that won Food and Drug Administration approval for generic Lovenox in July 2010.
Lovenox is used for preventing and treating conditions, such as deep-vein thrombosis and conditions related to angina and heart attack. Though Sanofi originally sought and won approval for the drug as a pharmaceutical drug, experts said its molecular complexity places it more in league with biologics. As such, the FDA’s approval of Sandoz’s version was seen as a milestone in the path toward an abbreviated approval pathway for biosimilars.
The Food and Drug Administration approved Amphastar’s version of the drug in September, and Watson has the exclusive right to distribute it in the U.S. retail pharmacy channel. Watson said it was reviewing the court’s decision and weighing options, which could include an appeal.
NYC mayor Bloomberg, health commissioner Farley highlight importance of flu preparedness
NEW YORK — New York City mayor Michael Bloomberg and health commissioner Thomas Farley received their seasonal flu vaccine on Saturday at a Duane Reade pharmacy in the Bronx, demonstrating the importance of taking steps to prevent the spread of the virus.
“Every year, New Yorkers lose their lives to the flu, and a flu shot is the single most important protection against getting sick and spreading the flu to others,” Bloomberg said. “I urge everyone to go to their doctor, local health clinic or pharmacy and get a flu shot as soon as they can.”
“A perfect example of preventive care is getting your annual flu shot to protect yourself and your loved ones. And no one makes it easier to get immunized in New York City than Duane Reade and Walgreens,” Walgreens market VP Jeff Koziel said. Duane Reade is a subsidiary of Walgreens. “Flu shots are available at our pharmacies daily with no appointment necessary during all pharmacy hours. We appreciate mayor Bloomberg and commissioner Farley recognizing the important role of community pharmacists in health care.”
Flu shots are covered under Medicare Part B, as well as most insurance plans. All Duane Reade and Walgreens pharmacies also offer Fluzone HD, a high-dose influenza vaccine for those over ages 65 years and older, in addition to other qualified individuals.
The typical flu season coincides with the busiest travel period of the year, and last season that spelled trouble for more than 3 million U.S. vacationers whose trips were interrupted by flu-related illness, as the Walgreens Flu Impact Report suggested.
The findings in the survey, which were previously reported by Drug Store News, examined the effects of influenza on people’s everyday lives and showed how the flu affected Americans’ vacations, holidays, social engagements, sporting events and more.
Last flu season, based on survey projections, millions of life’s special events may have been impacted, including:
More than 600,000 graduations;
Missed more than 1 million weddings were not attended;
More than 3 million vacations were canceled or interrupted ;
Nearly 5 million holiday celebrations were missed; and
More than 5 million sporting events were missed.
The Walgreens survey was fielded Sept. 1 to 8, 2011, to a Vision Critical Springboard America panel to a nationally representative sample of 1,200 Americans ages 18 years or older.