I tuned in to today's public affairs hour on Maine Public Radio and took notes, the substance of which follows.
- Islander

COMMONWEALTH CLUB OF CALIFORNIA
2/23/2010

Margaret Hamburg, M.D., FDA Commissioner

Products overseen by FDA represent 25¢ of every dollar we spend. Globalization has multiplied the scale of responsibility. Products today are imported from 300,000 foreign facilities. 20% of our food, 75% of fish come from outside the US and are also more liable to contamination. Pharmaceuticals increasingly also come from foreign sources.

Globalization and the shift in market for food & medical products has brought new challenges, including variety & complexity. Many have less regulation than U.S. Scale means oversight becomes enormously difficult. She cited melamine, ethylene glycol in toothpaste, contaminated heparin…economically motivated adulteration. They’re also aware of potential terrorist attacks to adulterate food & drug products.

In 2009, of 18 million ioncoming shipments, 500 inspectors were able to examine less than 1%. About 8% of foreign drug manufacturers are inspected each year. FDA must be able to follow production chain from raw materials to finished product. Actions to be taken:

1. Seek better controls at point of production. Work with manufacturers, regulators, suppliers.

2. Hold importing companies responsible for their supply chain.

3. Deploy resources strategically.

Q s & As

Q. Budget freeze: will it jeopardize food security? Are you concerned about terrorist attacks on food?
A. FDA has historically been under-funded & under-resourced. Hopes for better support in future. Biological terrorism is indeed a threat, and the system hard to secure.
Ed: I heard/read that the FDA was the only agency whose funds would NOT be frozen.

Q. Widely believed that scientific staff not large enough and lacking in talent. She’s been in office 8 months, what are her thoughts about staff?
A. Admits they need strengthening of their science base and state of the art facilities. Need to build strength of regulatory science and research, build knowledge and tools for assessing safety & efficacy of new products.

Q. What is FDA doing to monitor & track adverse effects in drugs post-marketing?
A. They are watching more closely the life cycle of a drug rather than pre-marketing only. FDAAA (FDA something Act) in 2007 strengthened post-marketing surveillance for emerging safety signals.

Q. What are penalties for companies selling tainted food or drugs?
A. Carrot & stick. Need authority to mandate recalls of foods.

Q. What authority does FDA have to regulate tobacco?
A. This is new regulatory power, since June. Marketing, labeling, composition and manufacturing of product all come under their oversight. They will be doing behavioral research to address youth smoking. Have already banned flavored cigarettes.

Q. DTC ads: do you have any authority?
A. Have regulatory authority over content & accuracy of information. We are only one of 2 countries that allows DTC. Challenge of Internet is great in terms of monitoring info & advertising.

Q. What is your favorite food, what wouldn’t you touch, what should consumers avoid?
A. She likes everything. Sensible eating is complex issue. Her mother said: everything in moderation; rotate your poison. Seriously, want to help make possible for consumers to have easy, clear access to nutritional information in labeling of processed food.

=adjourned 2 p.m. =