New FDA Commissioner Gottlieb Reorganizing Inspection StaffBy
Inspectors worked broadly, now will focus on one of six areas
No reduction in staff numbers seen resulting from change
Federal inspectors who ensure the safety of the nation’s food and medical products will begin specializing in certain areas, as new Food and Drug Administration commissioner Scott Gottlieb enters his first full week at the agency.
Workers in the FDA’s Office of Regulatory Affairs will begin focusing on overseeing specific product areas -- such as pharmaceuticals or medical devices -- rather than activities in their U.S. geographic regions, Gottlieb said Monday in a memo obtained by Bloomberg News. The staff of 4,000 investigates consumer complaints, oversees imported goods, and inspects domestic and foreign facilities to ensure compliance with agency standards. The initiative was proposed four years ago, with implementation set to start this month.
The refocusing “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work,” Gottlieb said in the memo. “We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have.”
Attention on FDA’s oversight has increased as companies produce more complex and powerful drugs and devices, and challenges to food safety mount. The agency doesn’t plan any reductions in employee numbers related to the new structure, Melinda Plaisier, associate commissioner for regulatory affairs, said in an email. Plaisier oversees the staff under the Office of Regulatory Affairs at the FDA.
Until now, the 20 district offices Regulatory Affairs reported to five region heads. Now, staff will report to six product-specific offices focused on:
- pharmaceutical quality
- medical devices
- biologic drugs, which are made from living organisms and include vaccines
- research, including protecting research subjects and assuring data quality
Employees who work on imported products will continue to oversee all types of FDA-regulated goods, while the agency’s 13 labs around the country will become more focused on specific challenges focusing on either food or medical products, tobacco and specialty, according to the memo.
In particular, the initiative will help the FDA implement the Food Safety Modernization Act signed by former President Barack Obama in 2011 by allowing staff to focus on specific commodities and receive training to more uniformly implement agency inspections, according to the FDA’s website.