Outgoing FDA commissioner: Regulation, when done right, 'not a roadblock'

U.S. Food & Drug Administration Commissioner Margaret Hamburg forcefully defended food and drug regulations at a National Press Club luncheon March 27, in her last formal public remarks before her April 3 retirement as the head of the federal agency that oversees products accounting for one-fourth of all U.S. consumer spending.

“Regulation, when it’s done right, is not a roadblock,” she said. “Smart, science-based regulation instills consumer confidence in products and treatments, it levels the playing field for businesses, it decreases the threat of litigation and it prevents recalls that threaten industry reputation and consumer trust.” she said.

The FDA has the task of not only approving medical products in a timely manner, but also ensuring that they are safe for consumer use. The agency periodically is criticized when a drug’s side effects prove to be harmful, or when it is slow to allow a life-saving drug on the market.

“The balancing of risks and benefits is absolutely fundamental to the FDA’s role. And it’s always a challenge. We joke at the FDA we have only two approval speeds -- too fast and too slow,” Hamburg said.

But she insisted that encouraging safety and innovation are not mutually exclusive tasks, a position which she implied is not widely understood on Capitol Hill.

Hamburg recounted her achievements at FDA, saying that the agency last year approved the most new drugs that it has in the last 20 years “

“Today,” she said, “contrary to what others would say, FDA approves drugs faster on average than all other advanced nations, and the vast majority of the time, the U.S. is the first country in the world to approve important and novel medicines.”

She noted that during her tenure FDA -- which also regulates such other products as food, tobacco and medical devices -- has worked to reduce trans fats in processed foods and to update the nutrition facts label on packaging. Of tobacco, she said the agency’s new authority to regulate it “is historic and transformative.”

Hamburg also pointed to the FDA’s scientific contributions, such as its role in creating a meningitis vaccine that benefits more than 200 million people around the world, and in creating a test to certify that sea food from the Gulf of Mexico is safe to eat following the BP oil spill of 2010.

Challenges facing Hamburg’s presumed replacement, FDA chief scientist Stephen Ostroff, include the regulation of medical devices. It’s an area that neither the U.S. nor the European Union have gotten “completely right,” Hamburg observed. “It is an area we need to continue to learn more about.”

Hamburg also emphasized that FDA needs to increase its engagement with stakeholders. “There’s great value in having industry, academia and government actually work together in shaping research in critical areas,” she said.

Another challenge for the agency is responding to globalization, she said, noting that about 80% of active pharmaceuticals ingredients, 40% of finished drugs, 85% seafood and 20% of vegetables are imported into the U.S.

Although FDA has introduced high-tech, risk-based screening systems at the border to allow it to target the most risky commodities, she said, “we really have to step beyond our borders to the places where the products are being manufactured, processed and distributed.”

Hamburg expressed concern about potential legislation in Congress that would overhaul the government’s regulation of the healthcare industry. She worries, she said, that it will create “unfunded mandates” for an agency she described as chronically underfunded.”