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FDA Needs To Change How It Regulates Novel Technologies

Scott Gottlieb, M.D.

(Forbes) – I spoke before a meeting of the International Society for Stem Cell Research in Berkeley, Calif., this week, addressing the need for the Food and Drug Administration to adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy.

The thrust of my message was this: FDA needs to more closely focus is organizational structure and its regulatory programs on measures of risk, and move away from its structural legacy that oriented its review programs mostly around discrete clinical areas of medicine.

More and more, it’s the product features of these novel technologies, and not necessarily their clinical applications, that create the hypothetical and known risks. The regulatory efforts need to be structured around these product areas. That means FDA needs to organize more of its regulatory activities around programs centered on areas such as regenerative medicine and gene editing. It needs to more closely adjust its regulatory approach to address the unique nature of the different risks that it’s trying to address.

It also means that FDA needs to focus on those areas that create the most potential for risk, and channel its resources behind these efforts. It needs to be much more risk based. Right now, FDA is often too easily distracted by attractive areas like iPhone apps that nonetheless pose relatively low risks and could be ably addressed by other regulatory agencies.

Here is the full text from the remarks I delivered at the meeting:

Six years ago, tainted peanut butter caused a nationwide salmonella outbreak that killed nine people and sickened more than 22,000 Americans. Many were like Jacob Hurley, who was only three when he fell ill. He hadn’t eaten peanut butter, but crackers. The tainted peanut butter originated from a single Georgia plant. But the food maker shipped the paste nationwide. The raw ingredient was simultaneously used in the production of everything from cookies, to crackers, to ice cream and even dog biscuits. The infectious danger didn’t start revealing itself for days. First, it had to run the full course of its incubation period.

The episode reinforced in the minds of FDA’s senior staff an awareness that was long forming when it came to food safety and the limits of the agency’s regulatory program. The nature of food processing had changed substantially in America. Much of it owed to corresponding changes in food packaging and the logistics for faster shipping. The scope of outbreak from foodborne illness no longer has a clear geographic boundary.

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