Going toe-to-toe with the critics
Dr. Margaret Hamburg
FDA Commissioner Margaret Hamburg wields tons of power in the drug business. Like it or not, the FDA is arguably the most important agency to the global biopharma industry, serving as gatekeeper to the world's largest national drug market. And Hamburg's efforts to inject greater scientific rigor into the agency's reviews of new drugs will have a significant impact on the future of the industry.
Drugmakers slipped into an era of low productivity in terms of winning drug approvals in the last decade, and many unhappy industry advocates have placed the blame for their problems on the FDA's doorstep. Hamburg and her team have crafted a strategy that has emphasized the use of science and technology to improve the way the FDA does business, and those actions have begun to give some industry chiefs some faith that the agency will become less of a wildcard.
"There's a new level of predictability since Peggy Hamburg came in as FDA commissioner [in 2009]. So we're not frustrated, because we understand how to react now to discussions that we have with them, which wasn't the case just a few years ago," Novartis CEO Joe Jimenez said in an interview with Smart Money, adding that politics had hindered activities at the agency in the past.
This isn't to say that Hamburg and the FDA don't still have critics. For instance, key players of the biopharma industry believe that the agency has stalled the advancement of drugs for obesity, diabetes and other primary care conditions. Hamburg and her drug lieutenant Janet Woodcock have the power to provide clarity on how the agency will judge such treatments, making the already risky process of developing the drugs more predictable for biopharma companies.
Hamburg faces more key tests this year as she fights for the agency's budget on Capitol Hill and the reauthorization of the Prescription Drug User Fee Act, a major source of funding for reviews of healthcare products. She'll go toe-to-toe with some of the agency's harshest critics in Congress who would like to see more drug approvals and fewer cases of dejected developers scratching their heads in confusion after their dealings with U.S. regulators.