We depend on the Food and Drug Administration (FDA) to protect our health by providing information and regulation for drugs and medical devices. But sometimes when times get tough, the FDA needs to depend on someone as well.
Marcia Crosse, Director at the Government Accountability Office (GAO) for the Health Care team, is that pillar. She believes that the role of the government is to provide responsible production and oversight of our medicine.
For her work, Crosse has been named a finalist for the Service to America Medals, also known as the Sammies – the Oscars for federal employees.
Meyers told Chris Dorobek on the DorobekINSIDER program how she created awareness and education for the Food and Drug Administrations regulations.
“Just like in a lot of industries, the production of prescription drugs and the production of medical devices has become a global enterprise,” said Crosse. “Drug companies and medical device companies are taking advantage of that to try to control their costs.”
The FDA’s model is based on domestic manufacturing and production in countries that have similar guidelines to the U.S. Unfortunately, the FDA’s system became outdated and failed to stay current as drugs came from unregulated regions such as third world countries, India, and China.
“The problem was that they would rely on European regulatory authorities doing inspections with similar standards, but they couldn’t necessarily rely on those inspections occurring in some of these developing countries that have just begun the large scale manufacturing processes,” said Crosse.
“The FDA estimates now that about 80% of the ingredients in prescription drugs are manufactured overseas. And about 40% of the finished drug products are manufactured overseas. And about 50% of medical devices are manufactured overseas,” said Crosse.
Our drugs today are truly global – for better or worse.
In response, Crosse helped create overseas offices that placed people on location to help when problems occurred.
Regardless of the manufacturing being domestic or international, new laws create somewhat of a risk-based system. The facilities making the riskiest products are subject to the most scrutiny.
“We recommended it and Congress made changes to that law – so that now FDA is developing a risk-based system,” Crosse explained. “So the places that are making the riskiest and most complicated products get inspected more frequently.”
Crosse notes the FDA has increased efforts in order to keep up with the private drug companies.
“[The FDA] really stepped up to the plate. They’ve developed an entire strategic plan. They’ve reorganized offices. They’ve opened up locations around the world. They’ve hired a lot of inspectors,” said Crosse.
Many young people shudder at the thought of government work. But Crosse reiterates how her work is high-impact. Many of her academic peers became specialists but “they really don’t have the pleasure of seeing it impact what happens in people lives. And I think that we do. The federal government is crucially important to every citizen’s life in every way imaginable. It’s very pleasurable to see change actually occurring in a fairly short period of time. I think it offers enormous opportunity to make an impact.”
You can find all our Sammies interviews here.
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