Follow-on Biologics Proposals Raise Safety and Intellectual Property Concerns
Recent proposals (S. 623 and H.R. 1038) have been introduced in Congress that would mandate the Food and Drug Administration (FDA) to create an approval pathway for follow-on versions of biologic drugs.  On Thursday, March 8 the Senate Health, Education, Labor and Pensions Committee will hold an informational hearing on follow-on biologics.  CHI remains concerned that policymakers are attempting to rapidly move legislative proposals without adequately addressing complicated safety, scientific and intellectual property issues.  CHI is circulating a coalition letter from our member companies to support a careful and methodical approach by Congress and urges CHI members to sign-on.  In addition, CHI’s Federal Legislative Committee is actively reviewing various approaches to this complex issue.  To sign-on to the letter or for more information, contact Todd Gillenwater, CHI vice president-public policy (858.551.6677 or gillenwater@chi.org).

Science Research Bill Passes House Committee
The House Science and Technology Committee approved legislation (H.R. 363 – the “Sowing the Seeds Through Sciences and Engineering Research Act”) on Feb. 28 that would provide resources, incentives and opportunities for early-career researchers and graduate research assistantships, and establish a National Coordination Office for Research Infrastructure to set priorities for university and national research infrastructure.  CHI endorsed the measure in a support letter to Chairman Bart Gordon (D-TN) and the California members who serve on the committee, highlighting the interdisciplinary nature of life sciences research and how biomedical breakthroughs are occurring at the intersection of biology, chemistry, engineering, mathematics and computer science.  CHI believes that appropriate resources are necessary to foster these interdisciplinary programs to keep California and the U.S. at the forefront of global competitiveness and innovation.  H.R. 363 will move to the full House for consideration in the coming weeks.

Senate HELP Committee Reveals Legislative Schedule for User Fee Programs
The Senate Health, Education, Labor and Pensions Committee has announced a series of informational hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Modernization Act (MDUFMA).  The schedule will culminate with a mark-up of PDUFA and MDUFMA legislation on March 28.  Scheduled hearings and topics include: March 8 – follow-on biologics; March 15 – PDUFA and drug safety; March 22 – pediatric issues.  Because these two pieces of legislation must be reauthorized this year, it appears that they may serve as vehicles for other legislative proposals.  The House has yet to announce its plans or a timeline for consideration of PDUFA and MDUFMA.

Upcoming Hearings and Events:

• March 6 – 10:00 am (EST)
  House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies
  National Institutes of Health
  2359 Rayburn House Office Building
  Link
• March 7 – 9:30 am (EST)
  Senate Health, Education, Labor and Pensions Committee
  "Strengthening American Competitiveness for the 21st Century."
  216 Hart Senate Office Building
  Link
• March 7 – 9:30 am (EST)
  Senate Commerce, Science, and Transportation Subcommittee on Interstate Commerce, Trade, and Tourism
  “Policy Implications of Pharmaceutical Importation for U.S. Consumers”
  253 Russell Senate Office Building
  Link
• March 8 – 10:00 am (EST)
  Senate Health, Education, Labor and Pensions Committee
  Follow-on Biologics
  430 Dirksen Senate Office Building
  Link
• March 8 – 10:00 am (EST)
  House Appropriations Subcommittee on Commerce, Justice, Science and Related Agencies
  National Institutes of Science and Technology
  H309 Capitol
  Link
• March 9 – 10:00 am (EST)
  House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies
  Center for Disease Control and National Institutes of Health Appropriations
  2359 Rayburn House Office Building
  Link
• March 15 – Time: TBD
  Senate Health, Education, Labor and Pensions Committee
  PDUFA and Drug Safety
  Location: TBD
• March 22 – Time: TBD
  Senate Health, Education, Labor and Pensions Committee
  Pediatric Issues
  Location: TBD
• March 28 – Time: TBD
  Senate Health, Education, Labor and Pensions Committee
  Mark-up of Precription Drug User Fee Act (PDUFA) and Medical Device User Fee Modernization Act (MDUFMA)
  Location: TBD