More Guidance Needed on Company Duties in Outsourcing: FDA Official

Concerned about the upward trend in supplier quality issues, the FDA is considering agency-wide guidance to clarify manufacturers’ responsibilities for outsourcing, an agency official says.

The FDA sees the need for more clarity on its expectations for manufacturers using contract manufacturing organizations (CMO), Richard Friedman, associate director in CDER’s Office of Manufacturing & Product Quality, told WDL. Friedman spoke Tuesday on the topic at a Food & Drug Law Institute conference.

Outsourcing at least some aspects of manufacturing is now the norm and drugmakers should ensure their external supplier management is sophisticated, he said. They also must determine what kind of risk management will assure consistent quality from CMOs.

“They really have to have the right neural network in place and robust relationships with suppliers, including notification mechanisms and quality agreements,” Friedman said.

Companies run into trouble outsourcing because they often base compliance decisions on the larger corporate picture, which incentivizes reduced costs, said Cathy Burgess, a partner at Alston & Bird.

Drugmakers must determine how much due diligence is necessary when considering outsourcing, including looking at the qualifications of CMOs and other suppliers, the expense of doing overseas audits, management of upstream suppliers, quality agreements and possible language barriers.

They should also ensure their quality unit is adequately staffed and trained to oversee suppliers, Burgess said.

In international inspections, the most significant problem the FDA sees is inadequate laboratory controls. This accounts for 15 percent of overseas citations, Friedman said. Manufacturers need to conduct robust, external audits of all their suppliers to assure data in their submissions is authentic and validated, he added. — Meg Bryant