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U.S. Department of Health and Human Services

About FDA

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Executive Summary

The Food and Drug Administration (FDA) is entrusted with promoting and protecting the health and well-being of Americans. This means making sure that the medicines they take today are safe and effective. We also have another important role: promoting innovation to ensure that life-saving medicines continue to be developed and that Americans have access to new treatments as early as possible. One important means of supporting innovation is to maintain a state-of-the art drug approval process that brings important drugs to market quickly and efficiently. FDA’s performance during fiscal year 2011 (October 1, 2010 – September 30, 2011) demonstrates that the FDA continues to lead the world in rapid, high-quality drug reviews.

FDA approved 35 innovative drugs in FY 2011, many of them groundbreaking. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). But few years have seen as many important advances for patients.

These drugs offer important advances in treatment for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life-threatening diseases including:

  • Seven of the new medicines provide major advances in cancer treatment.
  • Ten are for rare (“orphan”) diseases which have few or no treatments because of their small patient populations.
  • Two new therapies, for lung cancer and melanoma, are breakthrough products for personalized medicine: each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits.

FDA accelerated the review and approval of these important drugs by utilizing “expedited approval” pathways and by streamlining clinical trial requirements to permit smaller, shorter, or fewer studies wherever possible. With the help of these tools and the resources collected under the Prescription Drug User Fee Act (PDUFA), FDA was able to review these 35 important drugs quickly and efficiently.

  • FDA approved 24 -- almost 70% -- of the 35 new drugs before any other country in the world, including the European Union (EU);
  • FDA approved nearly half -- 16 -- of the innovative drugs under the agency’s “priority review” program for drugs that may offer major advances in treatment; priority reviews carry a six-month target date for review;
  • FDA approved all but one of the 35 drugs on or before the target dates for approval agreed to with industry under the PDUFA; and
  • FDA approved the majority of these innovative drugs on the “first cycle,” that is, without requests for additional information.

FDA’s performance continued the agency’s global drug-review leadership in recent years. For example, a review of 57 novel drugs approved in both the US and EU between 2006 and 2010, FDA’s median time to approval for priority review drugs was less than half that of the EU’s (6 months versus13.2 months); for standard drug reviews, FDA’s median time to approval was 13 months versus the EU’s 14.7 months.

These results reflect many improvements in FDA’s drug approval process in the last several years. The agency has made great strides forward to speed the development and availability of drugs for serious or life-threatening diseases; it has launched the Critical Path Initiative to help streamline drug testing and review; and it has sharpened its focus on methods of efficiently identifying and resolving drug safety issues.

PDUFA was established by Congress to ensure that the FDA had the necessary resources for the safe and timely review of new drugs. It has played an important role in advancing the quality and speed of FDA’s drug reviews. PDUFA funding has provided the agency with additional resources for hiring and training scientific reviewers, keeping FDA scientists abreast of innovative technologies, and improving the scientific basis for regulatory decisions. The current legislative authority for PDUFA expires on Sept. 30, 2012.

FDA is committed to supporting innovation in the biopharmaceutical industry. Despite its record of high-quality, efficient drug reviews, both FDA and industry face challenges in drug development. It is critical to our public health mission that we work with industry and other stakeholders to take steps to reduce uncertainty and increase success in the other phases of drug development.

Commissioner Hamburg has therefore launched the Innovation Initiative, identifying additional steps the agency can take immediately to address the most pressing concerns facing patients and industry. The agency is dedicating resources and staff to expediting drug development at every stage. FDA has made advances in regulatory science, which can reduce the length and cost of drug development and increase its predictability. For example, FDA is working on initiatives to make clinical trials smaller, more efficient, and less uncertain, and to enhance use of pharmacogenomics and qualified biomarkers. FDA also is continuing to support the progress of personalized medicine, and is allocating more resources to expediting orphan drug development. With this effort, FDA can help speed the availability of new products, identify products that might be safer or more effective than existing therapies, and give physicians and scientists better information about how drugs work.

Table of Contents: Innovative Drug Approvals

Next Section: Introduction