FDA calls on Consumers Union for transparency input

The new Food and Drug Administration (FDA) Commissioner, Margaret Hamburg, is not wasting any time trying to restore the agency's tarnished reputation and restore its public health and consumer protection missions.

The agency held a public hearing and listening session this week to get input on how it can better communicate with the public about food and drug safety issues and become more open and transparent in all it does. I was one of those testifying, along with about 15 other speakers, and each of us praised the goal of a more open and accessible agency.

There was a substantial emphasis on using the Web as a vehicle for open communications, including quick posting of all actions—for example letters to drug companies that order them to change a drug ad because it's misleading or inaccurate. Many speakers said the agency had made a good effort to make its Web site better in the last year, but more needs to be done to make it still easier for consumers to navigate.

Consumers Union called for the agency to:

• Make information on the agency's interactions with industry, the data and analysis the FDA generates internally, its' path to decisions, and all clinical trial data fully public.

• Release the names and addresses of retail outlets where a recalled food product was taken off the shelves as soon as this information can be gathered. This enables local media outlets to report practical information to consumers who can then identify if they have possibly tainted products in their kitchens.

• Post information on the FDA's new drug ad site related to all actions taken and letters sent to companies regarding direct-to-consumer ads.

• Communicate more often and openly with the public on issues related to off-label drug use. That's when drugs are prescribed by doctors for uses the FDA has not approved. This is legal but carries risks. We think the evidence is now unequivocal that physicians and consumers need more federal guidance in this area.

• Involve consumers and patients in the next round of negotiations with drug companies over the user fees they pay to have drugs reviewed. This process takes place every five years and sets important standards for drug approvals.

• Put more people without conflicts of interest on the FDA's important drug review advisory committees.

• Post the results of the many Freedom of Information Act requests the agency gets on the FDA's Web site, after the requester has had the information for a certain period of time. Consumers Union is a frequent requester of such FOIA information.

—Steven Findlay, senior health policy analyst, Consumer Reports Health