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Terrance J. Bruggeman

Expert Insights: Regulatory reform

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Terrance Bruggeman is chairman, president and CEO of Geneve Bio Inc. and a member/mentor of the Chairmen's RoundTable.

What are your thoughts on the role of government regulation in your industry? How big a role should it play?

I believe the U.S. government's role, and that of its foreign counterparts, is absolutely required to ensure that new medicines are demonstrated to be safe and effective before they are allowed to be sold. That being said, there are several areas of regulation that could be enhanced to permit innovative new therapies to be brought to market.

First, there is no such thing as "absolutely safe" for all people. There are no absolutely safe airplanes or automobiles and the same can be said for drugs. Genetic and other differences in humans do not allow for all users of a particular drug to receive the intended benefit and, for a very small fraction of the population, they can potentially have an adverse reaction to a therapy. Recent Congressional oversight has made the Food and Drug Administration (FDA) very risk averse with the unintended consequence of reducing the approval of many promising life saving therapies. Sound, consistent guidance from the FDA combined with clear risk benefit analysis will be the hallmark of continued development of drugs for life threatening diseases.

Terrance Bruggeman

Second, the coordination among counties of approvals could reduce the duplicative cost and delay involved.

Is change needed? How much blame for the financial crisis would you lay on the backs of regulators?

Absolutely! The growth of unregulated financial instruments like credit default swaps and a large unregulated shadow banking system like the private equity and hedge funds has brought the world to the brink of disaster and has harmed many people who had no role in the financial system. The fragmented regulatory system -- with separate regulators for banks, securities firms, insurance companies, savings and loans, and the various government-sponsored housing lenders -- demonstrated that no one had the big picture in mind and were unable to provide consistent regulatory oversight.

Further, very important participants had almost no oversight. The hedge funds have become huge leaders and the credit rating agencies fall outside the scope of government oversight and regulation. And yes, I think some blame for this disaster must be born by the regulatory community. Similar to the intelligence failures leading up to 9/11, the regulatory community did not cooperate as well as was required. I find the most fault with Congress, which during the last 10 years has blocked many calls for a better coordinated, better staffed oversight of financial institutions operating in the United States.

What are your thoughts on Obama's proposed regulatory reforms? What did you like? Was there anything you didn't like?

I don't think they go far enough to provide consistent regulation such as capital levels and disclosure over the range of participants in financial markets. I'm afraid that it will cause continued competition rather than cooperation in the regulatory community, and we could have a repeat of the mess we are currently in.

-- Compiled by Rebecca Go

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