FDA Transparency Task Force Tackles Information Disclosure Challenges

Full article reprinted from "The Gray Sheet" - November 9, 2009

FDA has questions about whether to disclose information on product applications that a company abandons before approval or in some cases on applications in which review is still pending. Read more...

^{FDA Transparency Task Force Tackles Information Disclosure Challenges}

Full article reprinted from "The Gray Sheet" - November 9, 2009

FDA has questions about whether to disclose information on product applications that a company abandons before approval or in some cases on applications in which review is still pending.

The issues came up Nov. 3 at a meeting of FDA's Transparency Task Force in Washington, D.C.

The task force, comprising senior officials from all FDA review centers and other major offices, met for the second and likely final time. The group is developing new agency policies on transparency, with draft recommendations expected by December or January.

FDA's principle deputy commissioner and task force chair Joshua Sharfstein asked three expert panels to work through hypothetical scenarios about information disclosure to help inform the agency's recommendations.

One panel took up the question of what information is releasable after a pre-market submission has been withdrawn.

There are many reasons why a device, drug or other product application could be withdrawn, from safety concerns to business reasons, the panelists noted.

Ekopimo Ibia, director of global medical and regulatory policy at Merck, said FDA should carefully question the value of announcing application withdrawals. Disclosure is appropriate only in some situations, he said; namely, if the application is withdrawn because the firm detects safety or effectiveness issues in clinical trials.

But Heather Nigro, regulatory affairs manager at Covidien, urged that data be kept confidential "until the company decides themselves to move forward with approval."

Public health advocate Diana Zuckerman argued for full disclosure of every application withdrawal.

"We don't really know what the reason was" for withdrawal, said Zuckerman, president of the National Research Center for Women & Families.

"Studies have been done and those results will not see the light of day," she said. "Other companies may be developing similar products and they could learn from the results of these studies."

Ibia and Nigro warned against disclosing confidential trade secrets about unapproved products, but Zuckerman maintained that "public health ... has to trump proprietary information."

Sharing Information On Pending Applications

The task force also questioned a separate panel about whether FDA reviewers should release data about pending applications in certain cases.

Companies may publish data on pending product applications that give an incomplete or overly optimistic view of the product, FDA said.

In such cases, is it up to the agency to offer consumers a more complete picture of the device?

Panelist Richard Martin, an analyst at the American Society for Radiation Oncology, said patients need to know the context of the published data. If FDA thinks the studies misrepresent the product, then "yes, additional disclosure is important."

Pharmaceutical lawyer Michael Hinckle, on the other hand, again urged FDA to protect trade secret information at all costs. "The data is proprietary until it's published," he emphasized.

The "Tipping Point" For Risk Communication?

FDA is further struggling to define the "tipping point" at which product information should be disclosed to the public even when the agency is still spotty on all the details.

The task force sought input from a panel on how to issue early messages about potential or emerging problems without unnecessarily blacklisting a product or alarming the public.

The panel considered a scenario in which details about a foodborne pathogen outbreak trickled in while FDA deliberated about sending a message.

According to the panel, emerging safety information eventually reaches a threshold where it becomes "news you can use."

"You reach that sort of threshold or tipping point when the information becomes interpretable in a way that makes it possible for people to genuinely mitigate risks," said AnnaMaria DeSalva, worldwide health care director at public relations firm Hill and Knowlton. "That has to be the filter."

But some panelists suggested FDA must notify the public about unclear risks, as well, if they reach a certain magnitude.

In the case of foodborne illnesses, as cases pile up, "you're going to have to say something," Food & Water Watch lobbyist Tony Corbo said. "If you're talking about hundreds of people now and you have several states involved, you're going to have to say there's something going on here."

Sharfstein said he's not sure where to draw that line.

"You need news you can use if you're going to go out with a message, but what if there are a lot of people who are sick?" he said. "Until we know what it is, we don't say anything? At what point is this now big enough?"

"I'm not sure I know," the principle deputy commissioner concluded.

According to attorney Sarah Klein, Center for Science in the Public Interest, FDA must determine the tipping point on a case-by-case basis. "It makes sense for FDA to be picking a number [of incidents] that makes sense, that's not too low, but also not too high."

FDA questioned whether general messages about potential, but not proven, problems are helpful, and whether a company's market share should influence the decision to communicate uncertain risks.

Klein suggested it does matter. "I don't know where the bright line is on market share," she said, but "the larger the market share, the more obvious it becomes to me that the public should be notified."

Earlier this summer, the task force launched a Transparency blog, opened up the FDA Dockets for additional comments on key transparency issues and held a first public meeting of the task force in June (The Gray Sheet' June 29, 2009)
Comments on the three topics discussed at the meeting and other input on FDA's transparency initiative were accepted through Nov. 6. The Transparency Blog will accept feedback through the end of the month.

 

- Jessica Bylander

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