January 1, 1970 (Vol. , No. )

John Sterling Editor in Chief Genetic Engineering & Biotechnology News

GEN recently ran a poll on our website that asked the following question: “Does the FDA Do as Much Harm as Good?” The results might have seemed surprising to some people. The numbers read as follows: 49.2% said yes; 38.3% replied no; and 12.5% registered no opinion.

The reason I say “surprising” is that FDA officials often refer to the agency’s role as helping to foster medical progress and to assist the pharmaceutical industry in its “efforts to develop and bring to market new drugs and medical devices for American patients.”

What’s more, the FDA steadfastly maintains that its primary job and raison d’etre is to do all it can to ensure the safety and efficacy of all the products that it approves.

So why did the majority of respondents to our poll express such a negative opinion about the FDA? I think the answer lies in the delicate balancing act that the agency constantly has to employ in determining risk vs. benefit while studying and eventually approving new drug applications.

At a conference some years ago I heard an FDA official turned consultant pose this hypothetical situation to the audience: “If it is a matter of fact that a new drug will without question save the lives of 10,000 people but also will definitely lead to the certain deaths of 100 people, should that drug be approved for use?”

As I recall, there was a lot of murmuring among the meeting attendees but no one chose to respond to the question.

While this make-believe scenario represents an extreme situation it does shed light on the critical decisions that FDA officials must make regarding new drug approvals. I think it’s only right that we cut them some slack and show more understanding and appreciation for such an important task.

That being said, there is much that can be done to improve the overall functioning of the FDA, especially in expediting new drug approvals. As one president and CEO of a company developing cancer therapeutics told GEN, “The FDA should relax some of its regulations regarding new cancer drugs, particularly those for terminally ill people.”

Though chronically underfunded and short-staffed, even the FDA knows it needs to do better. The good news is that FDA Commissioner Dr. Margaret Hamburg recently initiated a program aimed at instituting major agency reforms. It’s entitled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”

Among the goals are rebuilding FDA’s small business outreach service, strengthening the infrastructure to drive and support personalized medicine, creating a rapid drug development pathway for targeted therapies, tapping into the potential of data mining and information sharing while protecting patient privacy, improving consistency and clarity in the medical device review process, training talented innovators, and streamlining and reforming FDA regulations.

It remains to be seen to what extent this new initiative will improve the performance of the FDA. But I think the agency should be applauded for reinforcing its commitment to its mission and hope that the next time we run a poll on the agency the results reflect a better feeling about what the FDA has been able to accomplish.

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