House lawmakers outline life-sciences agenda

Ensuring that health-related mobile applications are not hampered by excessive regulations and taxes, creating a board of directors at the Food and Drug Administration, and enhancing the security of the U.S. drug supply chain are among the top priorities this congressional session for leaders of an influential House health subcommittee.

In a briefing with reporters, Reps. Joe Pitts (R-Pa.) and Michael Burgess (R-Texas), the chairman and vice chairman, respectively, of the House Energy and Commerce Health Subcommittee, provided a roadmap of what issues they will explore in the 113th Congress to improve the life sciences in America. "We want to make sure if we have to legislate to protect innovation, we do that," Pitts said. The Pennsylvania Republican also noted that the leaders plan to host other "idea labs" that will similarly outline policy options in other areas of healthcare, including health insurance, Medicare and Medicaid.

As Pitts and Burgess explained, they intend to explore five areas of the life sciences through hearings and, possibly, legislation. One area calls for creating an FDA board of directors composed of patients, innovators and scientific experts that would evaluate the FDA's performance and make recommendations to improve it. The panel would be similar to the Medicare Payment Advisory Commission, which makes recommendations to Congress. Meanwhile, the leaders hope to push for including the term "innovation" in the FDA's statutory mission statement.

"If the FDA is not sensitive to innovation, it is by definition regressive or retrogressive," Burgess said, "and not going to have the best and newest treatments available to patients."

The panel will also examine ways to improve patient education that could help patients pursue new treatments, and create incentives to develop new antibiotics that address emerging threats. The antibiotic issue could surface, for example, in upcoming legislation to reauthorize the Animal Drug User Fee Act or the Animal Generic Drug User Fee Act. Burgess said events may dictate the timeline on how the panel addresses antibiotics.

"Congress is a reactive body at the end of the day," Burgess said. "If there are more and larger stories that appear about the difficulties hospitals are having keeping up with hospital or community-acquired infections, surely we will have to take that up in a more aggressive fashion."

Looking ahead to the long term, Burgess said a goal of the committee is to establish and streamline the pedigree for pharmaceuticals. As he explained, oftentimes pharmacists are asked if they know the pedigree of a certain drug, but often they are unable to provide that information to consumers and patients.

"They ought to be able to do that," Burgess said. "And they ought to be able to do without having to comply with 50 different state regulations."