May 1, 2006

An international effort between the U.S., the European Union and Japan to standardize industry submission and agency review of genomic data will move personalized medicine forward without increasing regulatory burdens, a high-ranking FDA official says.

The FDA is working with its counterparts in the European Medicines Agency (EMEA) and Japan's Organization of the Ministry of Health, Labor and Welfare (MHLW) to harmonize how regulators assess voluntary genetic data submissions and to clarify what they expect in drug applications when genomic data is involved, Felix Frueh, the agency's associate director for genomics within the Office of Clinical Pharmacology told FDAnews.

But, contrary to some industry concerns, these efforts will not result in greater burdens on industry, he said.

Some industry attorneys are concerned that a joint agreement between the FDA and the EMEA could foreshadow regulators' making genomic data submissions mandatory. But Frueh says this will not happen. "I am absolutely not concerned about this leading to an increase in required submissions," he said. This effort only codifies standard practice that regulators already use in assessing this data, he added.

This statement of principles will formalize the FDA and EMEA's practices for reviewing the voluntary submissions, including timelines for review and how feedback will be submitted to the companies, he said. This approach allows for greater transparency in how regulators review this data and ensures that the reviews are more thorough by establishment of information-sharing protocols.

Putting a formal process in place saves time, money and the burden that companies face by submitting the same information twice, to the FDA and then the EMEA, Frueh said.

The statement of principles should be released within the next few days, once the EMEA officials sign off, he said. The document is just "going through the bureaucracy" of getting the right people to read it. (http://www.fdanews.com/did/5_85/)