FDA Commissioner Stresses Regulatory Science at DIA


FDA commissioner DIA

Dr. Margaret Hamburg, Commissioner, U.S. Food & Drug Administration

Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, addressed the 46th Annual Meeting of the Drug Information Association (DIA) stressing the importance of regulatory science for the future of FDA and the biopharmaceutical industry. The DIA meeting, held in Washington, DC, is on the theme of “Facilitating Innovation for Better Outcomes.” Eight thousand participants are attending the meeting from 80 countries with representatives from 20 different regulatory agencies. Dr. Hamburg’s remarks stressed two specific points: regulatory science and the globalization of the commodities that are used in our food, drugs, medical devices and other FDA regulated products.

Dr. Hamburg spoke to a packed auditorium that had first been serenaded by the Adagio from Dvorak’s New World Symphony played by the Bel Canto Strings. She recounted that FDA had been formed as a result of the efforts of President Teddy Roosevelt who was president when the Pure Food and Drug Act was passed in 1906 and FDR who signed the Food, Drug, and Cosmetic Act into law in 1938. She gave ultimate credit to Abraham Lincoln who authorized the Bureau of Chemistry in the Department of Agriculture that eventually became FDA, noting that Lincoln was on the cover of the DIA program.

DIA Regulatory Science

Dr. Hamburg's First Year at FDA


She noted that she had now been FDA Commissioner for one year and that “the learning curve has been steep.” She said that it was a particularly challenging time with the different and complex requirements that come with the recognition that we live in a globalized world. Dr. Hamburg joked about her Aunt Minnie who asked why she didn’t become a “real doctor” when she took over the New York City Public Health Department. She said that her public health training has helped prepare her for the job of FDA Commissioner and to be a “real doctor to 300 million people.”

Dr. Hamburg stressed that a gap had been formed between bioscience and regulatory science, that the tremendous advances in research could not translate into products for the public health without the resources and skills for the regulatory scientists at FDA. She gave four specific examples where promising research required advances in regulatory science to bring products to market. She spoke about stem cell research for Parkinson’s disease that needed valid processes for development of the stem cells. She listed an Artificial Pancreas for diabetes that would allow a testing path that wouldn’t lead to severe hypoglycemic events. She also cited research from the National Institutes for Health that had lead to progress in tumor markers and in advances in drug-resistant tuberculosis.

FDA DIA Hamburg

The Percentage of Imported Food and Drugs Continues to Rise

Dr. Hamburg emphasized that regulatory science was “much bigger than FDA” and encouraged participation by industry and academia. She then turned to the challenges from a globalized market place noting that there are 20 million shipments of FDA regulated products imported into the United States each year. This includes 40% of produce, 70% of seafood, and 80% of active pharmaceuticals ingredients (APIs) and drug products. She said that FDA would increase the number of international inspections and personnel stationed overseas. However, she said that FDA alone couldn’t guarantee safe food and drugs and that there was a need to harmonize standards and approaches saying that the “new paradigm goes far beyond our borders.”

FDA DIA Regulatory Science

A Missed Opportunity?

Hamburg’s speech did not have any specifics regarding current issues in drug regulation including the recall situation at McNeil for children’s tylenol. It is unfortunate that she did not take the opportunity to directly address the biopharmaceutical industry with FDA’s current viewpoints or concerns regarding drug safety. It was a speech that did not mention the terms “good manufacturing practice” or “clinical trials.” In fact, it was remarkably similar to her speech to RAPS last summer in Philadelphia. That’s too bad. A very good speech but an opportunity missed.

However, DIA had a number of good sessions the first day. They included an excellent session on “Virtual Realities: Quality Considerations When Using Outsourcing Providers” chaired by Bruce Wagman and the equally excellent session on training chaired by Steven Steinbrueck. I’ll discuss these and the other sessions I found the most interesting in a few days.

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