A second information request by Sen. Sherrod Brown (D-OH) of the Senate Committee on Health, Education, Labor and Pensions (HELP) on the outsourcing practices of a major pharmaceutical company—this time Merck & Co.—is moving the issue of outsourcing into an uncomfortable zone of political expediency versus constructive debate.
Late last month Brown sent a letter to Merck’s President and CEO Richard T. Clark requesting information on the company’s outsourcing practices, including the amount of outsourcing the company does, from what countries, and the mechanisms for ensuring the chain of custody in its supply chain. Brown also had requested information on Pfizer’s outsourcing practices in June following testimony by Pfizer officials in April before the HELP committee. The committee held hearings to evaluate FDA’s inspection process following the well-publicized incident of contaminated heparin from a Chinese supplier.
The heparin incident was a wake-up call because it revealed unforeseen vulnerabilities in a pharmaceutical company’s supply chain. What it wasn’t and should not be is an invitation to blanket criticism of outsourcing.
Outsourcing is a well-established practice within the pharmaceutical industry. The sponsor or pharmaceutical company is responsible for ensuring the quality of its materials, whether produced internally or sourced externally, a situation not only required by regulation but also dictated by sound business practices for both the pharmaceutical company and its suppliers. This situation is not new.
It is also true that during the past several years, major pharmaceutical companies, including Pfizer and Merck, have been more vocal about how outsourcing fits into their strategies by publicly stating plans to increase their levels of outsourcing as part of cost-savings and resource-allocation efforts through supply-chain optimization and rationalization of internal manufacturing facilities.
What is important now is that the current debate on drug-import safety not be reduced to a debate on outsourcing. Outsourcing, whether done in the pharmaceutical industry or in other industries, is a hot-button political issue, particularly when it involves offshore suppliers. It evokes opposing views of free-trade versus protectionism and the resulting implications that those decisions may have on local economies.
Let’s keep the discussion to what it should be—a thoughtful examination on how to improve drug-import safety, including the inspection process of foreign drug-manufacturing facilities, and what, if any, specialized considerations need to be taken in monitoring the pharmaceutical supply chain.