NOV. 19–WHITE OAK, MD–In his first address as commissioner of the U.S. Food and Drug Administration (FDA), Mark McClellan told gatherers at groundbreaking for new agency facility here that changing the regulatory review process is a key factor in keeping up with medical technology advances.

“We can expect more breakthroughs resulting from a better understanding of the human genome and of the way proteins and other chemicals work,” McClellan says. “These new kinds of medical technologies may require some new thinking at FDA, in terms of how we should best design our review processes for drugs, devices and biological treatments to help Americans get safe and effective treatments as quickly as possible and at the lowest possible costs.”

McClellan, who was sworn in on Nov. 14, also says the FDA needs to do a better job identifying adverse events and improving drug safety. “[Another] challenge ahead for FDA is to help medical professionals and patients reduce preventable adverse events,” he adds.

The number of activities the agency is charged with regulating has been increasing, and is likely to continue to do so, McClellan says, adding that it’s a “good thing.”
He pointed out there are more drugs and medical devices available to save and improve lives than ever before. And there is still more to come. In addition, the United States is importing a larger volume and greater diversity of foods than ever before.

“There are broader choices in cosmetics, and in dietary supplements. As a result, Americans have more opportunities to improve and enjoy their lives than ever before. But this also means, more than ever, that FDA must think critically and carefully about how it uses its resources to improve the public health,” he says.

In some cases, he explains, it may require a reexamination and an updating of the way FDA does its job, saying the agency is not here to “just to check boxes on an inspection list, just because that’s the way we’ve been doing it for the past 20 years.”

Rather, the agency’s job is to implement the best possible approaches to reduce risks to the public health, using the budget and authority that Congress has handed down.

McClellan says the FDA also has a critical role to play in securing the country from terrorism by helping to make available safe and effective treatments for anthrax, smallpox, and other possible forms of bioterrorism. “And the FDA must act quickly to protect our food supply and other consumer products from new threats,” he adds.