At a time when the FDA is increasingly criticized for its oversight of foreign drug-making plants, the chief of its recently created International Compliance Branch has departed. Earlier this week, Edwin Rivera-Martinez, a 20-year agency veteran, joined Parexel International, the contract research organization, as technical vp for strategic compliance services.
In his role at the FDA, he oversaw compliance for inspections of human drugs and active pharmaceutical ingredients that are conducted abroad by the FDA. This is a crucial function at the agency, especially given the Heparin scandal in which more than 80 deaths and hundreds of serious reactions in patients three years ago. The cause was a contaminated ingredient from China, and some members of Congress have lambasted the FDA for failing to conduct a tougher investigation (see here).
His departure comes just as the US General Accountability Office released a report that found the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug-making facilities. The GAO wrote that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice (read more here).
Rivera-Martinez, who was previously a compliance officer in the FDA's Division of Manufacturing and spent 14 years as an investigator in the agency’s San Juan ddistrict office, could not be reached for comment, but a spokeswoman for Parexel confirmed he joined the CRO earlier this week. An FDA spokeswoman says that Carmelo Rosa is now the acting chief for the International Compliance Branch.
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1 Comment
Not much of a loss for the agency. Was part of the problem, not the solution.