FDA Hearing on Faster Clinical Trial Process

In January the FDA announced it will be holding a public hearing on February 4 and 5, 2013 to gather input on what may lead to a faster clinical trial process for drug and biological products development for “serious or life-threatening conditions that would address and unmet medical need”. If approved, an expedited drug development process will be permitted for smaller subpopulations of patients with “more serious manifestations” of a condition. Such a process will lead to faster clinical trials vs. typical studies involving a broader group of patients with a wide range of clinical manifestations.

New Labeling Required

Labeling for approved drugs under the proposed process must clearly show that the drug is “narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks.” Labeling requirements may include an appropriate logo to appear on the container.

Obtaining Public Comments

The purpose of the public hearing is to obtain information and comments on the “need for and feasibility of this pathway and its potential advantages and disadvantages”.

Other Highlights

The FDA recognizes that the resource-intensive programs required to approve drugs treating a “broad condition with a wide range of clinical manifestations” requires large study populations which can prevent a drugs from becoming available on a timely basis to patients with “important and unmet medical needs”.

It is important to explore the benefits and feasibility of a drug development process for smaller sub-populations of patients with serious or life-threatening conditions, including infections caused by antibiotic-resistant bacteria.

The approval of a narrow indication could be broadened if future data demonstrate the effectiveness and safety in treating a “broader condition or patient population”.

For further information, go to http://www.gpo.gov/fdsys/pkg/FR-2013-01-15/pdf/2013-00607.pdf

Impact on the Drug Development Industry

If approved, a streamlined clinical trial process for the development of drugs and biological products may have significant implications for pharmaceutical and biotech firms. Strategic planning and competitive intelligence will take on an added dimension. Forward-thinking strategists would do well to thoroughly consider the implications and the potential to gain a competitive advantage should approval be granted for an expedited drug development process.