Sen Brown has asked for specific information on the mechanisms Merck uses to track the chain of custody for reach ingredient used in its products, procedures to check that each facility in the supply chain adheres to its operating procedures and standards, and whether the US Food and Drug Administration (FDA) “periodically inspect every facility” that makes ingredients for the company.
He also asks for a detailed breakdown on the percentage of production that is outsourced to US providers, a ranking of the top 10 countries the company outsources to, and the estimated average and median wages paid at companies producing active pharmaceutical ingredient s(APIs) for Merck in each country.
Last month, Sen Brown (Democrat, Ohio) sent a similar letter to Pfizer asking it to defend its outsourcing policy, and also requested that the FDA look into the increasing tendency of pharmaceutical companies to source product of ingredients and finished products overseas.
In the latest development, Sen Brown points to Pfizer’s recently-announced second-quarter results, with a big hike in profits “due in part to cost-cutting measures.”
In April at a meeting of the Senate Health, Education, Labor and Pensions (HELP) Committee, says Brown, an FDA official “acknowledged that American drug companies outsource operations due to cost factors and the existence of weaker drug safety standards abroad.”
At the same hearing, he adds, a representative from Pfizer confirmed that 17 per cent of the company' active ingredients and drug manufacturing is outsourced.
"This is about corporate responsibility and consumer safety," said Brown. "Drug company profits cannot come at the expense of consumer safety. Pharmaceutical companies must be able to guarantee the safety of their products and trace the origin of their ingredients."
In a response to Brown’s letter, Pfizer said that outsourcing does not compromise the safety of American consumers and that “looser safety standards and lower costs do not motivate company decisions,” according to a statement from Brown’s office.
The Senator has now turned his spotlight on Merck because of comments by senior vice president of global procurement, Richard Spoor, who said earlier this year that the company has a target of outsourcing around 35 per cent of the manufacture of APIs, intermediates, formulated pharmaceuticals, sterile products, vaccines, and packaging by 2010.
“Merck's aggressive use of outsourcing is a pivotal development in the drug and biologic arena. I am confident that your answers to the questions above will help Congress evaluate the effects, positive and negative, of pharmaceutical outsourcing,” concludes the letter, address to president and CEO Richard Clark.
Merck could not be reached for comment by the time this article went to press.