FDA Breakthrough Programs Take Years off the Approval Process

The Food and Drug Administration (FDA) is being congratulated on a breakthrough in the conventional belabored FDA approval process. Ben Steele, contributor to Eye for Pharma reported that the pharmas Johnson & Johnson and Vertex Pharmaceuticals spoke out in support of the new approval process, which cuts years off the time it takes for breakthrough drugs to reach the market.

A blood cancer therapy, Ibrutinib, developed by Johnson & Johnson and Vertex is two years ahead of the planned schedule thanks to new FDA policies. Phase II studies are showing that the drug is set to make a huge impact on the cancer therapy market. Jay Seigel, head of regulatory affairs for Johnson & Johnson and Dr. Jeffrey Leiden, CEO of Vertex Pharmaceuticals, both stated that the new FDA process was proactive and iterative. The FDA was focused and fully involved allowing a quicker and smoother approval process.

The FDA reports that it has developed three distinct and successful approaches to bring certain drugs to market quickly – priority review, accelerated approval, and fast track. Fast track aims to expedite the process of drugs to treat serious illnesses where there are few alternatives. Priority review is a process for drugs that have demonstrated significant improvements over existing therapies. Accelerated approval uses a surrogate endpoint to approve drugs in a shorter amount of time.

Janet Woodcock, Director of the FDA’s drugs division confirmed that the new program was targeting certain therapies for genetic mutations. However, the program did not guarantee approval of any drug. A total of 67 applications had been submitted to the FDA as of July 12, 2013, of which 24 were awarded breakthrough designations and 18 were rejected.

There are problems with the expedited procedures. Foreign regulators may be hesitant to approve drugs that have been exposed to fewer trials, and insurers may not pay for drugs that have not received the traditional clinical trials.

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