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Hamburg: FDA Claims Global Leadership in Bringing New Drugs to Market

A mother is suffering from hepatitis C. A brother has just been diagnosed with late-stage melanoma. A son is told he has a rare form of lung cancer. A best friend receives a lymphoma diagnosis.

These people probably have not seen the charts and graphs in the report released this week by the Food and Drug Administration detailing the innovative drugs we have approved in the last 12 months.

They may not know that the agency’s doctors and scientists worked diligently to review and approve 35 novel, and even groundbreaking, medicines, including the first new drug to treat lupus in 50 years and the first to treat Hodgkin lymphoma in 30 years. And they may not have heard that two-thirds of these drugs were approved first in the United States.

But they do not need to. Statistics and numbers matter little when facing a life-threatening or life-altering illness. What matters to patients and their doctors are safe and effective treatment options that can heal and cure.

Ensuring that treatments and therapies get into the hands of those who need them also matters very much to the FDA; in fact, it is a fundamental part of our overall mission to protect and promote the public health.

The scope and scale of everything we do — from ensuring the nation’s food supply is as safe as possible to making sure medical devices heal rather than harm — keeps the FDA engaged in a wide variety of issues beyond the drug-approval pipeline. Yet, despite the vast portfolio of responsibilities the agency manages, we continue to be a leader in bringing new drugs to the global market and in opening new windows to treatment and new doors to prevention.

When criticism comes, it is often framed in comparison to our regulatory counterparts in Europe. But both the comparison and the criticism are misguided.

American patients generally have access to state-of-the-art therapies before the rest of the world. Of the 35 new drugs the FDA evaluated for quality, safety and effectiveness, the agency approved 70 percent of them ahead of anyone else in the world, including the European Medicines Agency. And this is not unique. An FDA review of novel drug approvals found that of 57 novel drugs approved from 2006 to 2010 by both the FDA and the EMA, three-quarters were approved first in the United States.

But making sure that drugs are safe and actually benefit those they are designed to help is not a competition. It is a complex process in which enormous amounts of data and incredibly complex scientific outcomes must be carefully evaluated.

When evaluating a new treatment or therapy, the FDA must meticulously balance the pharmaceutical industry’s vital need to innovate, and so ensure a robust drug pipeline, with patients’ rights to treatments they can trust.

We are successfully doing this, thanks to a concerted effort within the agency to build and create flexibility in the drug review process. The FDA has developed internal reforms aimed at making it easier to expedite drug approvals and has streamlined some regulatory requirements, reducing drug development costs.

But these changes are just the beginning. We are making it a critical priority to get drugs from discovery to delivery as quickly and effectively as possible, while never compromising our gold standard of safety. Among other things, we are calling for a renewed focus on comprehensive improvements in regulatory science and on strategies aimed at further advancing and spurring innovation.

The ultimate results of scientific innovation are certainly highlighted in the report we are issuing today. The new drugs the FDA has helped make available may have market names such as Zelboraf, Xalkori, Pradaxa and Incivek, but the names that really matter belong to the countless individuals these drugs will help and, in many cases, even save. Real people who, without even knowing it, have benefited from the agency’s tireless efforts and the dedication of every single FDA employee to improve the health of and better the lives of patients.

Approving the next generation of drug treatments is not a competition, but, in many cases, it is a race — to save lives.

And it is a race the FDA continues to win.

Margaret A. Hamburg, M.D., is commissioner of the Food and Drug Administration.

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