Just as the FDA has received the resources to make a major push into post-marketing drug-safety surveillance under the Food and Drug Administration Amendment Act (FDAAA), the Pharmaceutical Research and Manufacturers of America (PhRMA) says it’s doing the same thing.

PhRMA says its effort began long before the FDAAA legislation was enacted by Congress last fall.

PhRMA deputy VP for regulatory affairs Alan Goldhammer previewed the program at the 2008 Drug Information Association annual meeting. Reached after the conference, he declined to provide additional details about the project until later in July, when PhRMA will make a formal announcement. Goldhammer hints that a new organization might come of the surveillance effort, and says its executive board will be chaired by Janet Woodcock, deputy commissioner and chief medical officer at FDA.

Early Start

“We’d been working on this several years prior to FDAAA,” Goldhammer said, adding that 20 months ago, PhRMA sat down to sketch out the details on gathering and interpreting observational data that could prove more comprehensive than the post-marketing studies the industry does now.

As the FDA “starts moving forward, they won’t have to reinvent the wheel,” said Goldhammer. “We hope to develop some new metrics and tools along the way, which will also be in place out in the public domain for all to use.” Goldhammer said that PhRMA has spent “several million dollars over the last 18 months coming up with the concept of such a pilot.”

Goldhammer added that the trade group had hoped to have its surveillance effort headquartered at the Reagan-Udall Foundation, but that did not come to pass. (Congress didn’t fund Reagan-Udall fast enough.) PhRMA wanted to get going with its pilot, and decided to put it under the auspices of the Foundation for the National Institutes of Health, to which Bill Gates and several large pharmaceutical companies contribute research funds.

Backlash Potential

As best we can tell, the goal of the PhRMA pilot project will be to test a few new safety data sources and analytical methods. One obvious option will be to use federal databases or prescription and claims data from commercial sources. But it’s not clear how such data will be cleaned, who will perform the analysis, or what types of software and systems will be used. Will academic physicians play a significant role?

Such details could determine whether the PhRMA surveillance project is perceived as spin or a sincere effort to advance the state of pharmacovigilance science. In an era of unprecedented public distrust of pharmaceutical research, any new links between industry and FDA could backfire. While PhRMA has an honorable history of working with FDA to chart scientific policy on adaptive designs and other topics, the FDA now has its own weakened image to defend—and (in a few months) a new crop of politicians to educate.

by Suz Redfearn

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