FDA Manager Speaks at UNC-Greensboro

By Marisa Sloan

Staff Writer

Anyone who has taken prescription medication, gotten a flu shot, worn makeup or eaten food in the United States has benefitted from the work of the United States Food and Drug Administration (FDA). According to their website, the FDA is an agency within the Department of Health and Human Services (HHS) whose goal is to “protect, promote and advance the health and safety of the nation.” Lieutenant Lauren Woodard, a Senior Regulatory Management Officer of the FDA, visited UNCG on Nov. 22 to talk about the different (and sometimes surprising) ways she strives to improve public health.

Woodard’s current responsibilities are probably what comes to mind for most people when imagining a job at the FDA. Using her PhD in chemistry, she reviews drug master files (DMFs) that are submitted by drug manufacturers. DMFs include confidential information about the manufacturing process of a drug substance, and is typically filed when a firm wants to partner with another firm on a drug product while still maintaining intellectual property rights.

“Impurities could stem from starting materials, they could stem from the manufacturing process itself, other reagents or solvents, degradation of intermediates or any other materials and even equipment used in the process,” said Woodard.

Over a period of weeks, she analyzes a single DMF to ensure that manufacturers have made the correct drug substance with no potential of dangerous byproducts. 

Woodard has another job as well. As a uniformed officer of the HHS, she is also deployed to areas burdened by natural and man-made disasters, international public health crises and humanitarian crises.

“I consider my two roles to be very similar,” said Woodard. “In my primary position at the FDA, my goal is the protection of the public health through ensuring the drugs they are taking are safe. And my secondary role as a lieutenant in the public health services is no different. The goal is to promote and protect public health either proactively with volunteer roles or after the fact at disaster situations. Personally, I think the two roles actually go pretty well with one another.”

In May, Woodard was deployed to Washington, D.C. as part of the Unaccompanied Alien Children (UAC) Program. According to the Homeland Security Act, any child under the age of 18 without legal immigration status or a legal guardian is considered a UAC and transferred to a shelter for care and custody.

“We spent essentially 12 or 13 hours a day reviewing case files in Washington, D.C., where we were reading through the case files and we were determining whether or not they had been separated from their parents at the border,” said Woodard. “Which was extremely heartbreaking because… [the case file] tells why they were there, and why they were crossing the border and the situation that they came from in their home country.”

Woodard and the rest of her deployment team reviewed the case files in order to determine if the children could qualify for mental health services.

“UAC shelters provide housing, nutrition, routine medical care, mental health services, educational services, and recreational activities such as arts and sports,” said Commander Jonathan White, of the U.S. Public Health Service, in a statement from February.

As of February, the number of beds maintained by the HHS was 13,000.

“Every administration is going to be different,” said Woodard. “Our job doesn’t change regardless of who’s in charge, it still is the same job and we’re still expected to perform to the best of our ability regardless of the administration.”

Woodard said she would do the deployment mission again “in a heartbeat” because she knew she was helping the underserved—children that were removed from their parents at the border.

Categories: News

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