WASHINGTON — Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.
“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed by the Senate on May 18. “For FDA to reenter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”
Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area, including engaging academic scientists at research universities, along with industry, and [encouraging] more research aimed at addressing unmet scientific needs involving the safety and effectiveness of regulated products, as well as how to best leverage emergent science and technology to strengthen and streamline the drug and product review process.”
Dr. Hamburg also called for improving conditions for the agency's scientists. “We have extraordinary talent at the FDA, but over the years, important aspects of our scientific endeavor have been underresourced and underappreciated, and this must change,” she said. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need to do their job.”