Mass. health department reorganizes pharmacy board, sanctions three compounding pharmacies amid meningitis outbreak
BOSTON — The state health department in Massachusetts has made changes to the state’s pharmacy board and leveled sanctions against three pharmacies in the wake of a nationwide meningitis outbreak traced to a compounding pharmacy in the state, the department said.
Massachusetts Department of Public Health interim commissioner Lauren Smith said Thursday that the department had appointed to the Massachusetts Board of Pharmacy Southcoast Health System VP and chief quality officer Patrick Gannon; Blue Cross Blue Shield of Massachusetts senior director of performance improvement innovations Jane Franke; and Beaumont Rehabilitation and Skilled Nursing Center executive director Edmund Taglieri. Gannon and Taglieri are replacing Sophia Pasedis and George Cayer, respectively, whose terms have expired, while Franke is filling a vacant seat on the 11-member board.
"These respected healthcare professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry," Smith said. "We expect additional changes to the board after the Commission on Pharmacy Compounding issues its recommendations to Gov. [Deval] Patrick at the end of the month."
The change comes in the wake of a nationwide meningitis outbreak traced to contaminated supplies of the injectable steroid methylprednisolone acetate made at the Framingham, Mass.-based New England Compounding Center. As of Monday, the outbreak had sickened 541 people and resulted in 36 deaths in 19 states. A Food and Drug Administration inspection in October found widespread unsanitary conditions at the NECC, and there have been calls from FDA commissioner Margaret Hamburg and members of Congress for increased federal oversight of compounding pharmacies.
The Massachusetts health department said the state’s commission on compounding had been meeting regularly to look at best practices in other states and explore changes to address what it called the "regulatory gray area" surrounding compounding pharmacies.
In addition to the changes in the board, Gov. Patrick instructed the pharmacy board to begin checking pharmacies that produce sterile injectable medications and had already inspected more than a dozen. In particular, problems had been identified at three pharmacies: OncoMed Pharmaceuticals received a cease-and-desist notice due to issues with the storage of chemotherapy drugs, but the board was working with the company to resolve them; a partial cease-and-desist notice was sent to Pallimed Solutions in Boston to halt the production of sildenafil citrate, the active ingredient in Pfizer’s erectile dysfunction drug Viagra that is also used to treat pulmonary arterial hypertension, because inspectors had found improper components used to prepare and distribute the drug; The Whittier Pharmacist received a partial cease-and-desist notice due to violations in its sterile compounding operations.
Mylan launches generic hypertension drug
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.
Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.
The drug is a generic version of AstraZeneca’s Atacand HCT, which had sales of $56.3 million during the 12-month period ending in September, according to IMS Health.
Walgreens and Cystic Fibrosis Foundation share joint ownership of specialty pharmacy
DEERFIELD, Ill. — Walgreens and the Cystic Fibrosis Foundation on Friday announced they have completed a transaction giving Walgreens a significant ownership stake in Cystic Fibrosis Foundation Pharmacy, the parent company of Cystic Fibrosis Services.
Terms of the agreement were not disclosed.
The transaction gives Walgreens and the CF Foundation joint ownership of two businesses: CF Services, a specialty pharmacy for cystic fibrosis patients and their families; and Pharma Dynamics, a provider of new product launch support and call center services for drug manufacturers. CF Services will continue to operate under its current name and remain based in the same location in Bethesda, Md. Pharma Dynamics was previously CF Services’ Corporate Accounts Division.