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Jill Wechsler is BioPharm International's Washington Editor, firstname.lastname@example.org.
Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.
FDA commissioner Margaret Hamburg has received praise and plaudits as she exits FDA this week after six years on the job. This past month, she made her final case for boosting FDA’s budget in appearances before House and Senate appropriations committees. The legislators greeted her warmly, while holding off on funding promises. She marked the 20th anniversary of the European Medicines Agency with a speech in London emphasizing the importance of FDA–EMA collaboration, of efforts to improve the transparency of clinical trial data, and of greater reliance on reports from each others’ inspection programs.
The challenges created by increased globalization in food and drug production also was a main theme in Hamburg’s farewell speech last week at the National Press Club in Washington, D.C. She reiterated the need for more collaboration and coordination with foreign regulatory partners, noting that increasingly complex global supply chains and a surge in food and drug imports have prompted FDA to change how it does business and to establish outposts around the world to support overseas field inspectors.
Hamburg also emphasized the need for continued investment in regulatory science to identify unmet medical needs, facilitate expedited review of important new therapies, and enable standards for assessing the benefits and risks of new therapies. Hamburg strongly disagreed with critics that paint FDA as an obstacle to developing innovative treatments for Alzheimer’s disease and other serious conditions: when regulation is “done right,” she asserted, it “isn’t a roadblock-it’s the actual pathway to achieve meaningful and lasting innovation.” She maintained that, “it is foolish-in fact dangerous-to believe that reducing regulatory standards will make new treatment interventions appear if the science is not there.”
An important related issue for Hamburg is “responsible communication of scientific information” related to unapproved uses of medical therapies. While she urged efforts to strike “the right balance between fast access and good science,” she also cited the need to avoid approaches that undercut incentives for sponsors to conduct studies needed to demonstrate that a drug is safe and effective in treating added conditions.
In conclusion, Hamburg highlighted the importance of FDA basing its decisions “on science-not politics.” She expressed concern that Congressional proposals in the 21st Century Cures Initiative would create “unfunded mandates” and end up lowering standards for new products. She recalled that when she came on board as commissioner, FDA faced serious resource threats and eroded public confidence in its decisions. Today, she said, the agency is “stronger, more engaged, and more effective” and ready to meet new challenges, a task that will fall to the next FDA commissioner.