Envisioning 2.0

It’s been a wild, wild few weeks at the Food and Drug Administration. Since Andrew von Eschenbach took the helm, the agency has engaged in a number of defensive moves designed to assuage critics and pre-empt Congressional action. However, the agency can’t seem to catch a break as observers on all sides pan the FDA’s actions. In addition, von Eschenbach had to backpedal after he made remarks that seemed to indicate he would punish FDA officials who went around the system. Take a short ride on the FDA rollercoaster with me as I highlight some recent agency-related events.

Going Up: FDA Commish Talks Transparency At Industry Meeting

Late last month, von Eschenbach spoke at an interesting event held by the Center for Medicine in the Public Interest. During his remarks he pledged that the agency would be more open with the media. This sounded pretty good, as people have been urging the agency to be more open and proactive on the communications front.

Going Down: FDA Head Appears To Warn Agency Folks To Toe The Line

During the same speech, von Eschenbach spoke about how he would deal with people who have a problem with the way the agency is being run. According to Ed Silverman, who writes the blog Pharmalot, he said: “To go outside the process is destructive, not constructive . . . They aren’t speaking in the best interest of the FDA . . . I expect people to adhere to that, because that’s the way to do business. Otherwise, it’s chaos.” Some believed that he was discouraging open and transparent dialogue at the agency. More on this below.

Going Up: FDA Clarifies How It Will Report Drug Safety Information

On March 2, the FDA announced that it streamlined how it will report drug safety information. Rather than launching a special “Drug Watch” Web page featuring links to drug alerts, the agency decided to simply post this content on a single page that would be “easily accessible” to Website visitors. Some praised the move because they thought a “Drug Watch” page would sow confusion and panic.

Going Down: Critics Slam FDA For Abandoning Drug Watch Project; Burying Safety Information

John Mack, who writes Pharma Marketing Blog, was quick to slam the FDA for abandoning the Drug Watch project. He said: [The FDA’s action] is a far cry from the Drug Watch Site proposed by the FDA in 2005 . . . [You also can’t find the link to the page from the FDA’s home page.] On that page, I see a prominent link to “Recalls, Product Safety,” which does NOT concern “emerging” safety information, but full-blown safety disasters! For the consumer and [healthcare] professional this is like closing the barn door AFTER the cows have left!

Going Up: FDA Publishes Rules Governing Advisory Board Participation

The FDA published new guidance designed to help staffers ensure that advisory board members are free from conflicts of interest. According to the new rules, “if an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise.”

Going Down: Critics Say The New Rules Will Have A Negative Impact

Robert Goldberg, of CMPI said on his blog Drug Wonks: [J]ust as you saw an exodus of the best and brightest from the NIH as a result of a restrictive and hyper-reactive cap on consulting to crack down on the appearance of the appearance of a conflict, the same will happen with Advi Comms at the FDA. You will get mediocre, unmotivated or ideologically driven researchers populating committees and using the proceedings to promote their particular positions.”

Clearly, the FDA is in a hard spot. It is balancing the interests of numerous constituents and can’t please everyone. Compounding the situation are statements by von Eschenbach that have been less than clear. For example, he has had to parry accusations that his remarks at the CMPI meeting indicated he favors agency staffers who toe the line.

Hopefully, von Eschenbach will take the time to provide some context about the FDA’s recent moves on the safety, conflict-of-interest and transparency fronts. If he doesn’t, we’ll all continue to be unwilling riders on the FDA’s communications roller coaster.

This entry was posted on March 23, 2007 at 12:05 pm and is filed under FDA and the Pharmaceutical Industry. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.