PHARMACY

AstraZeneca develops Path to Employment program with local nonprofit group

BY Alaric DeArment

WILMINGTON, Del. Anglo-Swedish drug maker AstraZeneca and a local nonprofit group in Wilmington, Del., are combining efforts to teach job skills to students with disabilities, AstraZeneca said Tuesday.

The drug maker and Opportunity Center Inc. will create a program called Path to Employment, which will teach job skills to disabled students in a corporate setting to students in the area. Under a partnership with the local Brandywine School District, OCI has provided comprehensive career exploration to students with significant barriers to employment for the past two years.

The Path to Employment program will include short-term, unpaid assignments with AstraZeneca corporate security, the fitness center, the medical suite and the human resources department. Students will be trained to greet visitors to the corporate campus and help them find their destinations. The program, which will include tours, job shadowing days and mentors, is designed to provide students with a chance to develop social skills required for the workplace.

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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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