Pfizer seeks to stop generic versions of Lipitor
NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.
Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.
Dr. Reddy’s Labs, based in Hyderabad, India, had planned to launch its own version in May 2012, but Pfizer has filed a lawsuit against the company to delay the launch, alleging that the launch would infringe its patents.
The last of the patents protecting Lipitor’s use in adults is set to expire in July 2016, according to the Food and Drug Administration. The drug had U.S. sales of $7.5 billion in 2009, according to IMS Health.
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Senator to float bill to address drug shortages
EDINA, Minn. — Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.
Klobuchar revealed her concerns on Dec. 30 while speaking at Fairview Southdale Hospital in this Minneapolis suburb. Noting that pharmacists and other health providers are reporting serious shortages of prescription drugs, especially for chemotherapy, she said she would introduce legislation this month to provide the FDA with new tools to deal with potential drug shortages.
“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available,” Klobuchar said. “That’s not right. There needs to be better coordination between the pharmaceutical industry, the FDA and healthcare providers so patients don’t lose access to the medications they depend on.”
Klobuchar said her legislation would give the FDA the authority to require early notification from pharmaceutical companies when they decide to limit or discontinue production of prescription drugs. In addition, the proposed law would arm the agency with the authority to establish an expedited process to approve substitute treatments or the importation of safe, clinically equivalent drugs from outside the United States when there is an impending shortage of a drug.
“We want to respect the private market, but we also need to protect the public’s health,” Klobuchar said. “This is a common-sense solution. It’s not too much to ask to have an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible.”
In December, Klobuchar sent a letter to FDA commissioner Margaret Hamburg requesting “immediate action” to ensure adequate supplies of essential drugs. Those in short supply, she noted, include everything from morphine for pain relief to propofol for sedation to leucovrin for cancer.
“There is also a serious shortage of prefilled epinephrine syringes used in emergencies to treat heart attacks and allergic reactions,” Klobuchar’s office reported. “Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on production of low-cost generic drugs in favor of more profitable brand-name drugs.”
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Sam’s Club starts new year with new health services
BENTONVILLE, Ark. — Sam’s Club announced that it is offering its business, advantage and plus members tools to help them achieve their health goals, including free monthly, in-club health screenings and access to a new health management benefit, The Prevention Plan, from U.S. Preventive Medicine.
Sam’s Club said it now is offering The Prevention Plan at $99 for its members. The program involves an online health assessment and at-home blood test to identify potential health issues for which a personalized plan is developed to address risks. Personal health coaching, ongoing support, a variety of tools and a plan-wide health challenge are provided through The Prevention Plan to keep members motivated to maintain a healthy lifestyle, the company reported.
"Through our member insights, we know our members want to stay in control of their health," said Jill Turner-Mitchael, Sam’s Club SVP health and wellness. "We’re proud to offer these simple health solutions, including free health screenings, along with great products like The Prevention Plan so our members can maintain control of their health decisions, minimize health risks and keep healthcare costs low for their families, employees and themselves."