Sen. Sherrod Brown (D-OH) is renewing his probe into the effect of drug company outsourcing on drug safety by asking Merck to explain the safety implications of its outsourcing practices. Brown, who earlier cast his skeptical gaze of Pfizer, in July released a letter he’d sent to the company asking for more information on its reliance on global outsourcing for manufacturing pharmaceutical ingredients and finished products.
He cited a statement by Merck senior vice president Richard Spoor that the company is “moving in the direction of externally sourcing approximately 35% of the overall manufacture of active pharmaceutical ingredients… and packaging by 2010.”
“Drug company profits cannot come at the expense of consumer safety,” Brown said. “Pharmaceutical companies must be able to guarantee the safety of their products and trace the origin of their ingredients.” In the letter, Brown asked Merck to provide: the specific mechanisms used to track the chain of custody for each ingredient in the drugs and biologics the company sells; the procedures used to ensure that every facility in the chain operates in a manner consistent with Merck’s quality and safety standards; the percentage of external sourcing that has been contracted to US-based companies; the top 10 countries to which Merck outsources, based on the percentage of business outsourced; a rough percentage break-out of the types of outsourcing for which Merck has contracted in each country; and the estimated wages paid at companies producing active pharmaceutical ingredients for Merck in each country, compared to the wages that would be paid had Merck manufactured those items internally.
Brown said he would also like the company’s analysis of the top reasons that typically prompt a decision to outsource to China, India or other developing nations, an assessment of the impact of outsourcing activities on the price of the medicines sold in the US, and the strategies Merck uses to ensure the products manufactured by contractors meet the same quality and safety profile as those applicable to Merck-manufactured products.