December 9, 2005

The drug industry may be changing its position on whether user fees should be increased to fund activities not directly related to product application reviews, potentially supporting fee hikes to pay for improved risk communication.

During a recent FDA-sponsored meeting on risk communication, officials from PhRMA, Pfizer and the American Medical Association (AMA) acknowledged that they would not necessarily oppose agency efforts to increase user fees during the next incarnation of the Prescription Drug Use Fee Act (PDUFA) in order to improve FDA risk communication efforts. The current PDUFA program is due to expire in September 2007.

Alan Goldhammer, PhRMA's associate vice president for regulatory affairs, told the agency that while the association had not formed a position yet, it was currently studying whether risk communication should be a factor in determining new user fees. Pfizer is also considering that approach, said John Wolleben, the company's senior vice president for safety and risk management.

This discussion comes as stakeholders told the FDA that its current strategies for communicating risk information, such as its website, drug labeling and patient information sheets, are inadequate. Specifically, these stakeholders, including academics and activists, said the data was confusing and, at times, misleading.

PhRMA is considering whether to support increased fees because it understands that industry and the agency need to do a better job of communicating risk, Goldhammer told FDAnews. Risk communication is "something we're all not doing as optimally as we should," he said. Additional fees would provide the money for the FDA to revise its risk communication program and develop goals or deliverables for improving risk communication, Goldhammer added.

But this announcement comes only weeks after industry balked at the agency's proposal to raise user fees to cover direct-to-consumer advertising review and enforcement. During a Nov. 14 public hearing to discuss PDUFA reauthorization, PhRMA officials were skeptical about the agency's call for fee increases to cover non-application-related meetings, arguing that the move may represent an unauthorized tax on drug companies.

However, improving risk communication could be seen as part of the drug approval process, Wolleben said. Risk management planning is part of drug authorization and that includes greater transparency, Wolleben said. More transparency will help the agency make decisions, he added. "Maybe there's an opportunity there." But first industry needs to consider whether all parties, including drugmakers, would benefit from fee increases, Wolleben said.

Meanwhile, the AMA will likely change its position on user fee increases. Originally the association had opposed raising user fees for purposes other than accelerating drug approvals. But recent drug safety incidents have led the association to believe that these fees should go toward improved risk communication, John Cranston, AMA's director of science, research and technology, told FDAnews.