As the United States began importing greater numbers of prescription drugs and medical devices, the Food and Drug Administration (FDA) found itself ill-prepared to conduct inspections of thousands of foreign manufacturing plants and provide the kind of strict oversight needed to fully protect public health.
In her role as a watchdog for Congress, Marcia Crosse of the Government Accountability Office (GAO) placed the spotlight on the serious regulatory problems at the FDA caused by globalization, prompting an increase in funding, the opening of FDA offices in countries like China and India, greater numbers of foreign manufacturing plant inspections and improved data collection to create a better understanding of overseas companies.
In addition, Crosse sounded the alarm on a number of other significant issues facing the FDA, including shortcomings in the tracking and reporting of critical drug shortages, the lack of controls over compounding drug pharmacies, the inadequate authority regarding the recall of defective medical devices like pacemakers and body implants, and the difficulties the agency was having reviewing applications for many complex new products.
“Health care has changed dramatically over the past two decades, but too often the FDA was caught unprepared,” said Gene Dodaro, the head of the GAO. “Marcia Crosse has been at the forefront of identifying needed improvements in the oversight of medical products. As a result, Congress has enacted into law many of Crosse’s recommendations to improve FDA operations and protect public health.”
Half of all of the medical devices used in the United States are imported, while 80 percent of the active ingredients in pharmaceuticals sold here are manufactured abroad. Because of her rigorous reviews, Crosse demonstrated that the FDA was operating with an outdated system in which its inspections and operations mainly focused on domestic manufacturers.
She pointed out, for example, that at the rate the agency was inspecting China’s manufacturers, it would take almost 50 years for it to visit each Chinese facility. She also uncovered inadequacies in the FDA’s data, its staffing and its ability to follow up on serious deficiencies once they were uncovered.
In the wake of congressional hearings featuring Crosse’s testimony, the FDA developed a plan to reorganize operations and created an office to oversee global activities. It established a permanent presence not just in China, but in India, Europe, Latin America and sub-Saharan Africa, boosted the number of inspections of foreign establishments and improved its data to manage the overseas inspection program.
Crosse drew attention to the FDA’s lack of authority to require manufacturers to report drug shortages. During congressional hearings, she demonstrated the FDA needed new powers and highlighted the agency’s lack of systematic data and inadequate agency resources. The issue was particularly acute regarding anesthesia and oncology drugs.
“The original law required manufacturers to notify FDA of a potential drug shortage only if they were the sole provider of that one particular drug. If one of three manufacturers were going to suspend production, they didn’t have to tell the FDA,” said Geraldine Redican-Bigott, GAO’s assistant director for health care. “Now any maker of any life-saving drug is required to notify the FDA if manufacturing is delayed or if there are problems with quality.”
In addition, Crosse examined the lack of FDA authority to oversee compounded drugs after a serious fungal meningitis outbreak in 2012 that was caused by a contaminated injectable steroid made by a compounding pharmacy. The tainted drug has been linked to 751 infections and 64 deaths. Congress acted on her recommendations, clarifying the FDA’s authority in the 2013 Drug Quality and Security Act, and it has already begun to issue guidance to pharmacies that compound drugs.
Crosse also testified at congressional hearings involving lapses in medical device recalls, making recommendations that became part of the 2012 Food and Drug Administration Safety and Innovation Act. The FDA is now implementing these improvements in its oversight of defective or unsafe medical devices that pose serious health risks.
Redican-Bigott said Crosse is a creative thinker who understands the issues, gets to the bottom of problems and communicates clearly to Congress and to the FDA.
“Her subject-matter expertise and her ability to convey that in a very collegial and constructive way is what really makes her an asset to the GAO and the public-health community,” said Redican-Bigott.
Patricia Dalton, GAO’s chief operating officer, said, “Marcia represents excellence in public service through her commitment, expertise and desire to make a difference for the American people.
“It’s not just that the government is working better, but also that the American people are better off,” said Dalton.