FDA's New Acting Commissioner Takes Helm

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-07-2015 09:47


As previously announced, Dr. Stephen Ostroff, MD,became the US Food and Drug Administration's Acting Commissioner of Food and Drugs, effective April 1, 2015, following the departure of former FDA Commissioner Margaret Hamburg, who had announced in February 2015 that she would be leaving her post at the end of March. Dr. Ostroff, formerly FDA's Chief Scientist, will serve as Acting Commissioner until a successor is named. Hamburg had served as FDA Commissioner since 2009.

In her last public address as FDA Commissioner, delivered at the National Press Club Newsmakers Luncheon in Washington DC on March 27, 2015, Hamburg emphasized the progress she felt the agency has made under her tenure and the issues that will continue to shape the agency's direction.

"I think most would agree that I came to the FDA at a time when the Agency faced considerable difficulties and uncertainties. A series of visible foodborne outbreaks had resulted in disease, nationwide anxiety and economic disruption. Several drug safety crises—Vioxx for one—had eroded public confidence. At the same time, FDA was facing serious resource threats. Budgets were tightening with the economic crisis, but chronic underfunding had already stretched the agency thin in many critical areas, and jeopardized our ability to keep up with inspectional demands, product reviews and with evolving science and cutting-edge biomedical products at the very time that scientific and technological discoveries were revolutionizing medical products. FDA’s challenges were exacerbated by the increasingly global marketplace for the products we regulate. Imports of FDA regulated products were growing dramatically, and there was a series of serious episodes associated with adulterated products coming from oversees, most notably the imports from China of tainted heparin, and melamine contaminated dairy products and pet foods that caused deaths and serious illness. These effects and constant negative drumbeat in the media, combined with Congressional criticism took a toll, public trust was flagging…yet it was clear that there was much good work going on. Indeed, as I took stock of the agency--its vast responsibilities, and its enormously talented and committed workforce –it was clear that FDA was at crossroads…and decisions made then would matter in fundamental ways and for a very long time. If FDA was truly to fulfill its mission in the modern era, this was a critical time to reposition."

Hamburg emphasized her area of focus during her tenure as FDA Commissioner. "To do this, I focused on three priority areas: increasing public engagement accountability and partnership; re-invigorating our scientific base by advancing regulatory science and underscoring the need for science-based decision-making—and scientific integrity-- as the foundation for all we do; and lastly, addressing the challenges of globalization and the huge implications that has for health, and for the safety and security of the products we regulate.

She emphasized the FDA's Transparency Initiative to increase stakeholder involvement, the role of the agency in advancing regulatory science, as well as advancing new drug development through various review mechanisms, including the Breakthrough Therapy designation, authorized by the Food and Safety Innovation Act of 2012 as well as other existing expedited review programs to speed the development and availability of medical products that treat serious diseases, namely fast track, priority review, and accelerated approval.

She also, however, emphasized the importantce of striking the right balance between fast access and good science. In the race for the newest treatment, we must remember the point that innovation doesn’t matter if the product doesn’t work. I cannot emphasize enough the critical need to maintain the standards of safety and effectiveness for medical products in this country."

She also pointed to the greater globalization of the pharmaceutical and food industries and the FDA's role in overseeing pharmaceutical product and ingredient supply outside the United States. She cited data that nearly 40% of finished drugs consumed in the US are made elsewhere, and that approximately 80% of the manufacturers of active pharmaceutical ingredients used in the United States are made outside the US.

"The result of these changing dynamics is that at every step in our increasingly complex global supply chains there are potential risks to the consumer – through improper formulation or packaging, contamination, diversion, counterfeiting, or adulteration. This has huge implications for our health, safety and national security," said Hamburg. "We no longer can rely on simple inspections at the border to ensure the safety of the products Americans consume. We have introduced new hi-tech, risk-based screening systems at the borders, but we must also work to prevent problems before they reach our borders. This requires greater coordination with other nations and international organizations to strengthen quality and safety oversight in the countries of origin. And we have established FDA outposts around the world to serve as hubs for inspections as well as improved communication with stakeholders. Most importantly, we increasingly collaborate and coordinate with our global regulatory partners, using enhanced intelligence, information and workload sharing to ensure safety and quality regardless of where a product is produced," she said.

Source: FDA


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