Regulatory and Washington

NEW YORK — The Washington state government's cap on quaffable spirits popped open Wednesday as voters there passed a ballot initiative to allow private retailers to sell liquor, according to published reports.

ST. LOUIS — In an amendment dated Nov. 7 and filed to the Securities Exchange Commission on Tuesday, Express Scripts reduced its termination fee by 32% to $650 million. The termination fee is paid to one company when the other terminates the merger agreement.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

ALEXANDRIA, Va. — In response to a new second set of limits on generic drug pharmacy reimbursement that recently were proposed by federal Medicaid officials, the National Community Pharmacists Association on Tuesday reiterated its concerns with what the group characterized as the "flawed methodology" being used by the Centers for Medicare and Medicaid Services to determine the payment caps.

NCPA requested a meeting with CMS officials on the matter.
 

SILVER SPRING, Md. — The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

In the letter, Hamburg announced the appointment of Lisa Barclay. Barclay, currently a partner at the Washington law firm Zuckerman Spaeder, will replace Molly Muldoon, who was previously chief of staff and more recently the agency's acting COO.

WASHINGTON — Tobacco companies received a favorable ruling Monday and as a consequence will not have to institute new graphics that depicted images like diseased smokers on their packaging next year.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday announced the establishment of two awards that will be presented annually, beginning in 2012.

NEW YORK — A new report from the Food and Drug Administration indicated that Roche division Genentech may not have followed proper procedures to prevent the contamination of certain drugs, according to published reports.

Dow Jones Newswires reported that an FDA report from September regarding an inspection of a plant in South San Francisco, Calif., found problems related to gaskets and caps used to cover vials of the cancer drug Avastin (bevacizumab).

The caps are made by a contract manufacturer, according to the reports.