Margaret Hamburg’s Remarks at Peking University, Beijing

Margaret A. Hamburg, M.D., Commissioner of Food and Drugs – Remarks at Peking University, Beijing
Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at Peking University in Beijing, People’s Republic of China, on August 10, 2010

Good afternoon—and thank you Dr. Zheng for that generous introduction. I am so very pleased to be here. This is a very happy occasion for me, but let me begin by expressing my deep sadness and sympathy for the tragedy that occurred in Gansu province. The mudslide has taken so many lives, injured others, damaged communities, and, of course, many are still missing. My heart goes out to the people of the area and to China more broadly, and I know that the American people join me in sending sympathy and concern.

I have heard a great deal about Peking University, about its exemplary academic programs, its unique history, its tradition of intellectual freedom and curiosity, and its beautiful, traditional Chinese architecture. So it’s a real pleasure to be here today to see this great university for myself. Many of my colleagues have told me about the generous welcome you have given them in the past, and I am grateful to have the opportunity to experience your hospitality today.

As part of my job as Commissioner of the U.S. Food and Drug Administration, I often have the opportunity to speak to students from America’s top universities and medical schools—and I’ve always found these opportunities to be extremely rewarding. Today, I look forward to a similarly productive and engaging discussion with this group of very accomplished and promising young scientists and innovators. I am also delighted that we are joined by distinguished faculty of this great university and key leaders in Chinese industry.

This is particularly exciting for me given the ongoing and fruitful collaboration between Peking University and the US Food and Drug Administration—which I just had the chance to speak about with some of the university’s leaders.

In fact, Peking University and the US FDA were founded less than a decade apart—the University in 1898 as Imperial Capital University, which quickly became a respected center for progressive thought and scholarship. And FDA in 1906 after President Theodore Roosevelt signed the Pure Food and Drug Act to protect the American public from “misbranded, or poisonous or deleterious foods, drugs, medicines, and liquors.” More than a century later, in 2005, we began to build a strong relationship between PKU faculty and the US FDA, specifically with our Center for Drug Evaluation and Research.

At least to some extent, the master’s degree in International Pharmaceutical Engineering Management—the degree that many of you here today are currently pursuing—is the result of that collaboration. The degree provides a systematic way to study quality systems in pharmaceutical management, regulatory science, pharmaceutical science, engineering business and leadership—fields that I view as essential to producing the leaders we need to meet the new and demanding challenges of the 21st century. In fact, these are areas of study that I hope will continue to be formally built into more programs at American universities, as well.

I think we can all agree that the collaboration between this university and my agency provides an excellent starting point for conversation.

Interestingly, I also have another, slightly more personal connection to this university through the world-renowned Rockefeller Foundation. The foundation has been of the most crucial American supporters of the University—and I spent some time serving on Rockefeller’s Board of Directors.

So for many reasons, I am delighted to be here. So this afternoon, I’d like to spend some time telling you about my vision for my agency, the US FDA, as a global organization and give you a sense of the challenges that our increasingly globalized world poses for the US FDA as we consider the future of drug development and drug safety. Then, I will talk more specifically about our initiatives in China and how we can continue the type of collaboration and cooperation epitomized here at Peking University.

When I accepted the job as Commissioner just a little over a year ago, I knew I wanted to lead the US FDA to become a truly global public health agency. And that meant engaging in a more strategic way on an international scale, especially with strong, dynamic and transitioning countries, such as China.

We all recognize that we face unique, 21st century challenges—and that’s particularly clear in the medical products industry. The world in which drugs and medical devises are discovered, developed and marketed is effectively now global, and the products have in reality become global commodities. And given the enormous responsibility and scope of the US FDA, this makes our job as a science-based regulatory agency even more challenging. We oversee products that people really need, products they care about, and products that matter in a fundamental way to their health, safety and well-being.

Consider that the FDA regulates products that account for between 20 and 25 percent of every dollar spent by American consumers. This includes food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements, animal drugs and feed, and certain products that emit radiation. And, for the first time in its history, the FDA has now been given the power to set and enforce standards to regulate the manufacture, marketing, and distribution of tobacco products.

We as an agency are responsible for ensuring that each of these foods, drugs and medical products meet our scientific safety and quality standards before they reach the dinner tables, medicine cabinets and homes of the American people. And in the case of medical products, we must monitor safety throughout their lifecycle, even once a drug or device is approved for the marketplace. We are the last line of public health defense, so it is critical that we do our job completely and responsibly. It’s a matter of bringing the best science to bear to support the best possible public health outcomes.

And now, more and more FDA-regulated products are being imported into the United States—from more than 150 countries. About 80 percent of active pharmaceutical ingredients in drugs consumed in the U.S. come from outside our borders, and, in the past 10 years, we’ve seen tremendous growth both in the total number of foreign products as well as the number of foreign facilities where products are manufactured.

And there has been a significant increase in data from clinical trials for new therapeutics being conducted in China and other countries. Many of these studies will be sent to the US FDA as primary data to support marketing applications to place products on the U.S. market. Knowing that the clinical trials data that inform us about new drugs are conducted ethically and in accordance with internationally accepted scientific practices is critical to assuring that new medical products will be safe and effective when they are authorized for marketing.

We have already seen the negative public health consequences of not having widespread internationally accepted and harmonized practices and standards. The recent problems with contaminated heparin, the melamine-tainted milk products, the international problems with diethylene glycol adulterated products, and the growing prevalence of substandard drugs make clear that we must bring our oversight in line with the reality of the global economy. We know that the economies of our two great nations are intertwined. Recent challenges have reminded us that the products the United States and China exchange have a real effect on the public health of our citizens.

Certainly, this means finding more sophisticated strategies for detecting and addressing problems with imported goods at the border. But even under the best of circumstances, that approach is limited, especially when you think about the vast numbers of products coming in through hundreds of points of entry around our country. Realistically, no matter how diligently we work, we will barely scratch the surface.

No regulatory authority has, or will never have, the resources to inspect every shipment of products from overseas, nor will we have the ability to inspect every foreign manufacturer and facility. We need new approaches. And more importantly, we cannot accomplish this task alone.

So we will work closely with our sister regulatory authorities—especially China’s State Food and Drug Administration—as well as with international and national organizations, and with industry. We will find new ways to share information. And we will learn, step by step, to leverage international resources to accomplish our domestic mission.

Today we are involved in a wide range of international activities—including efforts to harmonize scientifically rigorous standards; share scientific and technical expertise; engage in technical cooperation in applicable regulatory disciplines; strengthen detection, surveillance and assessment systems; and design innovative new information systems… and we are working hard to strengthen and extend these efforts.

We also now have a permanent US FDA presence in 10 foreign locations. These foreign postings have done as much as anything to confirm to the world that the US FDA is serious about its international mission. Through our foreign offices, FDA is building strong interpersonal and inter-organizational working relationships with our counterpart agencies in-country and with regulated industry. These relationships are necessary to build the trust that leads to collaborative institutional relationships.

And the benefits of this new paradigm for global product safety will go well beyond our borders—in fact, they will go well beyond public health.

When governments collaborate to invest to help strengthen the global capacity to produce food, drugs, and other medical products in accordance with strong safety standards, exporting countries gain multiple benefits: a domestic source of safe, quality products and economic development through productive industry and a strong, reliable export market. All countries gain access to safer, higher quality products. A win-win situation for all involved.

The new global reality requires new global partnerships—and our partnership with China is particularly key.

That’s why it’s now more important than ever that we promote regulatory public health cooperation between the U.S. and China … a country with which we have so many shared interests. As you know, China is increasingly a leader in many aspects of biomedical science and medical product development. Strikingly, China has become the world’s largest supplier of active pharmaceutical ingredients required for pharmaceutical products and certain supplements— and exports a large proportion of these ingredients to countries around the world. Correspondingly, China’s internal capacity for research and manufacturing has grown as well—as has the number of applications for new drug and device clinical trials and new medical products.

Of course, becoming a leader in drug production has also brought out a new set of challenges for China’s program—including a strain on resources; the need to improve the compliance and quality systems as well as current good manufacturing practices; the appearance of substandard products; serious cases of economically-motivated adulteration; concerns around supply chain integrity; and questions about good clinical practices, including ensuring adequate clinical trial oversight and data integrity … to name a few. China has already begun to address these challenges with new, updated standards and methods; a revision of China’s GMPs that SFDA s currently undertaking; and improved tools to detect counterfeiting and track and trace within the supply chain. We are very supportive of these changes and look forward to our continued work with our Chinese counterparts on these and other challenges that we all face.

We have been working with the State Food and Drug Administration here in China through an US FDA/SFDA Agreement to support many of these efforts, and with great success. But, of course, this is only the beginning.

We can place an even greater focus on improving cooperation between our countries, between our regulatory agencies, and, of course, between our academic communities.

For our part, the FDA has already developed a set of broad initiatives to strengthen collaboration with our sister regulatory agencies here in China and to increase our collaboration in this country. These efforts include working with our counterpart agencies to: gather more knowledge about product production and distribution; to create and foster synergies with scientific, inspectional and other resources in-country; to build science-based regulatory capacity; to engage with industry public- and private-sector third-party auditors; and to perform more inspections of high-risk facilities.

Our ultimate goal, of course, is to ensure that all products and data meet safety and quality standards before they reach our ports, so that we maintain the safety of the supply chain no matter where it originates. All of these collaborative activities will clearly benefit the health of people—and industry—in China as well.

We have a larger, shared mandate that we must also address. We must also use this opportunity to increase the amount of resources—financial and intellectual—that we put toward strengthening the field of regulatory science … the science and tools we need to assess and evaluate a product’s safety, efficacy, quality and performance. As the IPEM master’s students know, we need regulatory science to develop new methods, standards and models that we can use to speed the development, review and approval of medical products—and to ensure that they are safe before we distribute them within our respective countries and around the world.

Regulators have a special responsibility to ensure that the regulatory pathways used to evaluate and approve new drugs and medical devices are as effective and efficient as possible. The regulatory pathway should be the road that facilitates quality product development and a roadblock only to products that are not able to demonstrate their public health benefits. Regulators need to help identify the types of studies and data that will be needed for rapid development and independent regulatory assessment… and that will expedite authorization of new submissions and availability of new products to patients. We need to harness the extraordinary advances in science and technology to address the regulatory challenges—whether basic discoveries involving biomarkers or genomics that help us identify toxicities early on… or new clinical trial designs and analytics that can help us get the effectiveness data we need with fewer patients and shorter timeframes… or new techniques for data mining and bioinformatics that can help us identify emerging safety concerns in the post-market environment.

Regulatory science can also play an important role in supporting quality assurance. Through the Quality by Design guidelines, for example, the Internal Conference on Harmonization worked with the US FDA and other agencies to set forth a framework for regulation to promote quality assurance. It requests a risk-based approach requiring that companies have as complete information as possible up front on the risk of the medical product in development and how these risks might be mitigated.

It all comes back to applying better science and more innovative approaches to the drug development process and regulatory assessment. I see regulatory science as the link between cutting-edge science and technology and progress in the form of safe and effective new medicines and therapies. And I have made it one of my top priorities as Commissioner to increase America’s focus on regulatory science and help build a strong, robust field that, I hope, can further invigorate innovation and the medical product development process. And I am asking other regulatory leaders around the world to join me in this quest.

One of the key components to improving regulatory science, both in America and here in China, is the commitment of the academic community. Science is, after all, a global enterprise. WE must engage the best and the brightest minds in science today… and their energy, dedication and vision. That’s why programs like this one at Peking University are so essential to the progress of product development, to the success of the medical products industries, and, ultimately, to the future of medicine and healthcare.

I cannot end these remarks without quoting and least one Chinese proverb. “If you want happiness for a lifetime,” the saying goes, “help the next generation.”

I am confident that your studies here at PKU will give you the skills and the perspective to become the next generation of leaders in the field of medical product development. You will be prepared for the unique demands of the 21st century—ready for the new set of challenges that tomorrow will surely bring.

I wish you all the best of luck. Thank you so much—and now I am happy to take your questions.