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."
Inomax’s market exclusivity gets extended
CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.
Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.
Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.
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