The FDA Takes on Biomedical Innovation

As part of its new "Innovation Initiative," the FDA released a report entitled "Driving Biomedical Innovation: Initiatives for Improving Products for Patients." The report addresses the immediate steps that the FDA can take to improve public health while bolstering the economy and increasing innovation in the biomedical industry. We were intrigued to see that many of the report's recommendations are in line with what PDUFA V seeks to achieve: a regulatory environment that is predictable, transparent, and allows the biomedical industry to deliver safe, innovative cures to patients in need.

Unsurprisingly, one of the biggest barriers to innovation is regulations that are unclear, ineffective, or outdated. The report concludes that the guidelines of the drug review process must be simplified in order to ensure safety and consistency. The U.S. currently has more potential treatments in clinical trials than the rest of the world combined, but the inefficient and complicated drug review process means that patients may have to wait years before getting access to lifesaving medicines and treatments. Passing PDUFA V would eliminate unnecessary rules, removing barriers to innovation while ensuring that patients have access to safe, effective drugs as fast as possible.

The FDA's report also addresses its plans to establish a Small Business Liaison program. Small businesses are a cornerstone of all American industries, and are similarly important in the biomedical industry. However, the current regulatory environment undercuts their ability to invest in innovative research and compete effectively in the global market. By streamlining drug review guidelines and increasing the transparency of the regulatory process, PDUFA would help small businesses navigate the FDA process. This would allow entrepreneurs to invest wisely, grow their businesses, and make important contributions to the American economy.

The report also acknowledges the importance of maintaining U.S. global leadership in biomedicine. It recommends creating infrastructure that would facilitate innovation in targeted therapies and personalized medicine. Encouraging research in these important areas will not only result in breakthrough treatments for patients -- it will ensure that the U.S. remains the global leader in biomedical innovation and cutting-edge drug development. Reauthorizing PDUFA would help to decrease the review times for these medicines, meaning that new, effective treatments would reach under-served patient populations more quickly.

The FDA report provides even more evidence that Congress must reauthorize PDUFA in order to speed the delivery of safe and innovative medicines to the patients who need them most, while making sure that the U.S. maintains its position as the global leader of medical innovation.