Drugmakers hopeful of better FDA climate
NEW YORK (Reuters) - Drugmakers who have complained for years about caution and unpredictability at the U.S. Food and Drug Administration see signs the climate for reviewing new medicines may be improving.
Executives interviewed this week at the Reuters Health Summit said they were optimistic that new leadership and a boost in funding would help provide stability and lead to quicker product reviews.
"We are quite encouraged by the new tone at the FDA," said Joe Jimenez, head of pharmaceuticals at Swiss drugmaker Novartis AG (NOVN.VX).
"There is a willingness to try to understand the issue and listen, but also to be very strong and direct. I think strong leadership at the FDA is a good thing to have because then you know what the issue is and we know where we stand," he said.
Merck & Co Inc (MRK.N) Chief Executive Richard Clark said he welcomed the naming of FDA Commissioner Margaret Hamburg, who took the agency's top job in May after being nominated by President Barack Obama.
Clark said it was "very refreshing" to hear Hamburg talk about collaborating with the industry and giving guidance on how the FDA will evaluate new technologies.
Agency officials were stung by the 2004 withdrawal of Merck's arthritis pill Vioxx over heart risks and criticism from lawmakers for the handling of serious side effects of other widely used medicines.
Industry officials said that made reviewers overly cautious about approving new medicines.
More recently, FDA staff have been stretched thin by a growing workload and have sometimes missed target dates for deciding whether to approve new medicines, leaving them in limbo for weeks or months.
Congress responded by giving the agency stronger authority to react to drug risks after approval and by boosting the FDA budget.
AstraZeneca Plc (AZN.L) Chief Executive David Brennan said he thought it would take some time for those additional resources to make an impact.
"My expectation is that the change is going to be evolutionary, not revolutionary," he said, adding that he thought drugmakers "will continue to get more products through on an annual basis over time."
Companies have complained that various FDA divisions use different review standards that are not always clear to manufacturers. Brennan said some units "engage very well with us... so that causes me to think that things can get better."
Others said the FDA remained conservative on drug risks.
"Given some of the issues that have arisen with certain products being withdrawn and concern about safety in this decade, they tend to be right now more on the cautious side," Eli Lilly and Co (LLY.N) CEO John Lechleiter said, adding he was "encouraged" by Hamburg's work so far and hoped she would bring continuity to the agency's top post after years of turnover. Continued...
