Looking Back & Looking Ahead at U.S. Drug Approvals

Looking Back & Looking Ahead at U.S. Drug Approvals

01.08.13 | By Stephanie Fischer

You've likely seen the good news that the U.S. Food and Drug Administration (FDA) approved 39 New Molecular Entities (NMEs) in 2012, the highest number in 16 years.

The FDA seems optimistic about the future of medicines, saying in a quote to Reuters that the "pipeline of new drugs under development remains strong and is growing." Later this month, PhRMA will release a new report on innovation in the biopharmaceutical pipeline that highlights thousands of new treatment options that have potential to improve and extend patients' lives.

As a Forbes columnist noted with some excitement, 47% of the medicines approved last year were first in class (compared to 48% of approvals in 2011). First in class therapies utilize different mechanisms of action than other previously-approved therapies and are notable for their potential positive impact on patient care and public health.

What does the biopharmaceutical industry need to continue to provide innovative new medicines to patients who need them? In addition to public policy that supports and encourages innovation, an efficient, consistent and predictable science-based regulatory system is essential.

The recently reauthorized Prescription Drug User Fee Act (PDUFA) provides FDA with new tools and resources to help continue the higher approval trend. PDUFA V establishes an enhanced NME review program that is built on increased scientific communication between the FDA and drug sponsors during the regulatory review of new medicines. This has the potential to increase first-cycle approval rates and bring new medicines to patients faster. PDUFA V also provides dedicated resources to the FDA to advance regulatory science which will help make future drug development and review more efficient.

2013 has great potential for the biopharmaceutical industry and the patients we serve.

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