PHARMACY

CVS Caremark recognized for family-friendly benefits

BY Antoinette Alexander

WOONSOCKET, R.I. CVS Caremark has landed on Conceive magazine’s annual “50 Best Companies” list, a list of employers who are leading the way in corporate America with their generous family-building benefits, despite the challenging economy.

“At CVS Caremark one of our goals is to be the best company to work for and we have implemented many programs and initiatives to help us achieve that goal,” stated Lisa Bisaccia, SVP and chief human resources officer for CVS Caremark. “We have developed our benefits package to support our employees — dreams of starting a family in a variety of ways. Whether our employees give birth or choose to adopt, we have benefits available to help support them throughout their journey.”

Released in the summer 2010 issue of Conceive, and available at ConceiveOnline.com, the list highlights U.S. companies that offer their employees the best benefits for starting or adding to their families. The rankings are based on the company’s fertility and adoption coverage, including benefits for assisted reproductive technology and in vitro fertilization, infertility prescription drugs, paid parental leave and cash reimbursement towards adoption expenses.

CVS Caremark offers many family-friendly benefits, including financial adoption assistance, paid and unpaid leave for birth and adoptive parents, and coverage for infertility diagnostic procedures, fertility medications and assisted reproductive technologies up to $20,000 per employee.

Most employers, however, still have a long way to go, according to the Society for Human Resource Management. The percentage of companies that include IVF coverage has dropped from 28% in 2006 to 23% in 2009, and the percentage that offer adoption assistance has dropped from 22% in 2006 to 10% in 2009.

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Genzyme to correct manufacturing quality violations at Mass. plant

BY Alaric DeArment

SILVER SPRING, Md. Biotech company Genzyme will pay $175 million to the federal government as part of an effort to correct problems at its factory in Allston, Mass., the Food and Drug Administration said Monday.

The FDA announced that Genzyme had signed a consent decree of permanent injunction, agreeing to correct manufacturing quality violations and to adhere to a “strict” timetable to bring the plant in line with regulations. The payment to the government is a disgorgement to make up for profits from drugs made at the factory.

“It is critical for the safety of the drug supply that companies comply with basic manufacturing standards,” FDA principal deputy commissioner Jushua Sharfstein said in a statement. “FDA takes these obligations very seriously and expects manufacturers to do the same.”

During an inspection of the plant between Oct. 8 and Nov. 13, 2009, FDA inspectors found deficiencies in its quality-control systems, leading to shortages and contaminated drugs.

The company is the sole supplier of several enzyme-based biotech drugs used to treat rare genetic disorders. These include Cerezyme (imiglucerase), for Gaucher’s disease, which causes fatty substances to build up around the digestive organs, and Fabrazyme (agalsidase beta), for Fabry disease, which causes oil and fats to build up around the eyes and kidneys, among others.

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J&J subsidiaries to pay government for alleged Topamax promotion

BY Alaric DeArment

BOSTON Two subsidiaries of Johnson & Johnson will pay more than $81 million to the federal government over alleged illegal promotion of an epilepsy drug, the Food and Drug Administration said.

The FDA’s Office of Criminal Investigations announced Friday that Ortho-McNeil Pharmaceutical pleaded guilty in the U.S. District Court in Boston to one misdemeanor violation of the Food, Drug & Cosmetic Act for promoting the epilepsy drug Topamax (topiramate) for uses not approved by the FDA.

U.S. Magistrate-Judge Robert Collings sentenced the company to pay a criminal fine of $6.14 million. Another J&J subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, will pay $75.37 to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and cause false claims to be submitted to government healthcare programs for psychiatric uses that the programs did not cover.

In the case of Ortho-McNeil Pharmaceutical, the company allegedly hired outside physicians to accompany sales representatives on sales calls to healthcare professionals, including psychiatrists, through its “Doctor for a Day Program,” and promoted Topamax for psychiatric uses, even though it had never applied for approval of the drug for treating psychiatric conditions.

“We take the investigation and the settlement very seriously, and we’re fully committed to meeting the requirements of the agreement,” a Ortho-McNeil-Janssen spokesman told Drug Store News.

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