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Outlook FDA Innovates


For people on the medical products side, these have not been easy times. Te trend lines for innovative products relative to investments in research and development are not what any of us would like. Many companies are facing the so-called “patent cliff.” Worsening the situation is the unstable economy, changing rules for reimbursement, and, I know, concerns with the FDA—fears that a lack of predictability, consistency, and transparency in our decision-mak- ing processes and actions will lead to less investment in innovative technolo- gies and companies, as well as increased competition from foreign companies. Tese are challenges that we are working hard to address. Innovation is a core element of the


FDA’s mission. But innovation is not just about basic research and new discover- ies. It is about taking those new good ideas and translating them into products that are stable and reliable, that are safe and effective, and that will provide real clinical benefit for the patient. Innova- tion is also about finding new and better ways to do things to meet the needs and challenges before us. Tis is why regulatory science is so


important. Regulatory science is the science needed to assess and evaluate a product’s safety, efficacy, quality, and performance. It involves the develop- ment of new methods, standards and models we can use to speed the develop- ment, review, approval and ongoing oversight of medical products. It is, quite plainly, an essential


component of the scientific enterprise. Yet it has been under-appreciated, under-developed and under-funded for


many years. As a result, we have been unable to apply the best possible science and technology to the tasks before us. We cannot take full advantage of the breakneck speed of biomedical research unless we also emphasize innovation in regulatory science. Te FDA has developed a strategic


plan for regulatory science. Here are a few of the steps we’ve already taken: We’ve formed a Joint Leadership


Council with the National Institutes of Health to help promote the translation of basic and clinical research into medi- cal products and therapies.


FDA must not be a


roadblock. Just the opposite: Our job is to enable innovation.


We’ve established three Centers of


Excellence in Regulatory Science to con- duct targeted research, strengthen the training of FDA’s medical products re- viewers, and bolster scientific exchanges and collaboration. And we are working with the Reagan-


Udall Foundation, a private, indepen- dent nonprofit research organization, on several regulatory science projects. But we have another distinct but


related innovation task. As we advance the scientific underpinnings of our regulatory framework, we must also be sure that our regulatory pathways are as streamlined and modern in other ways as well. In plain English, FDA must not be a


roadblock. Just the opposite: Our job is to enable innovation—but without sac- rificing our high standards for ensuring safe, effective and high-quality products.


Tis is a difficult balancing act—and


one of the hardest aspects of my job. But it has to be something that we are ag- gressively focused on. And as an agency, we’ve had measureable successes. In the device arena, in 2011, aſter


taking a systematic and clear-eyed look at ourselves and a lot of outreach to indus- try, patients and the health care commu- nity, we identified 25 specific steps to help address unmet medical needs and reduce the time and costs of medical device de- velopment—and we have acted on almost all of them. We’re giving manufacturers clear information about how FDA judges the benefits and risks of medical devices during their pre-market review. And we’re providing much better guidance to companies developing similar versions of already licensed biological products. Te goal is to encourage product


innovation. Tat’s why our Center for Devices and Radiological Health cre- ated Innovation 2.0 pathway, a novel approach for working collaboratively to expedite approval of groundbreak- ing new devices. Tis new pathway was designed with the help of outside “entrepreneurs-in-residence” who developed the framework and operating procedures together with an FDA team. I’m proud of the changes FDA


has made over the years to acceler- ate drug and device approval—while never neglecting our duty to protect the public. But we cannot work in isolation. Finding new and more efficient ways to get products to people—while keeping those products safe and effective—is a responsibility we share with our private sector partners, with academia and with patients and consumers.


Medical Manufacturing 2013 23


Margaret A. Hamburg Commissioner


US Food and Drug Administration Washington, DC


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