PHARMACY

Advocacy group says proposed compounding regulations would endanger public health

BY Alaric DeArment

WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public’s health and safety at risk.

In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency’s authority in congressional testimony last month and offering a plan that would effectively weaken the agency’s oversight of drug manufacturing."

In testimony before the House Committee on Energy and Commerce last month, Hamburg proposed giving the FDA new power to regulate pharmacy compounding and creating two tiers for compounding: traditional and nontraditional. Traditional would include custom-made medicines for patients with individualized medical needs, while nontraditional compounding would cover compounding that some say effectively amounts to drug manufacturing. Public Citizen said the proposed rules would weaken existing regulations of drug manufacturers and create "substandard requirements" for compounding pharmacies.

The proposed new regulations were made in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass., which has so sickened 620 people and killed 39 in 19 states, according to the Centers for Disease Control and Prevention.


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Watson donates medicines to help Hurricane Sandy relief efforts

BY Alaric DeArment

STAMFORD, Conn. — Actavis has donated $200,000 worth of medicines to help people affected by Hurricane Sandy, a charity organization said Thursday.

AmeriCares announced that it donated the antibiotics, pediatric medicines and other drugs to healthcare providers helping affected families in New York and New Jersey within days of the storm. Actavis was acquired earlier this year by Watson Pharmaceuticals.

"Actavis responded swiftly and generously to meet the medical needs of storm victims," AmeriCares VP corporate relations Geoff Kneisel said. "The company’s donations were an amazing help and were immediately delivered to healthcare providers and first responders in the most devastated areas."


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Mylan, Orion settle Parkinson’s disease drug case

BY Alaric DeArment

PITTSBURGH — Generic drug maker Mylan has settled with Orion over a drug used to treat Parkinson’s disease, Mylan said Thursday.

The company said it reached a settlement with Orion to resolve patent litigation concerning a generic version of Orion’s drug Comtan (entacapone) tablets in the 200-mg strength. The drug is used with levodopa-carbidopa therapy to treat Parkinson’s patients who experience signs and symptoms of end-of-dose "wearing off."

Under the agreement, Mylan can launch a generic version of Comtan on April 1, 2013. Other terms of the deal were not disclosed. According to Food and Drug Administration records, the two patents covering Comtan expire in October 2013 and September 2018.

Entacapone tablets in the 200-mg strength had sales of about $104.9 million during the 12-month period that ended in September 2012, according to IMS Health.


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