INDUSTRY MAY SUPPORT USER FEE HIKES TO IMPROVE RISK COMMUNICATION
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.