May 11th Update: PDUFA/MDUFA
Yesterday, May 10th, the
House Energy and Commerce Committee approved H.R. 5651, the Food and Drug
Administration Reform Act (including the reauthorization of PDUFA, and the
other policy initiatives such as Accelerated Approval reform, conflicts of
interest reform, etc.) by a vote of 46-0. It is likely that this
legislation will be considered by the House of Representatives in the next few
are a couple of high-level talking points talk to your congressional office prior to the legislation being considered on the House Floor:
- This bill will enhance drug development by promoting greater FDA transparency
and communication with industry.
- The bill includes an enhanced accelerated approval pathway which will help
expedite the development of new therapies for serious and life-threatening
diseases, while maintaining the FDA’s high standard of safety effectiveness.
- The bill also includes the permanent reauthorization of the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric Equity Act (PREA)
Have Questions about PDUFA, MDUFA or the FDA Reform Act?
Contact Bryan Renk at 608-236-4753
March 7th Update: BioForward on Capitol Hill for AdvaMed Fly-in
BioForward's executive director, Bryan Renk
was in Washington D.C. on March 1, as a part of the AdvaMed
fly-in. Meetings took place with the
offices of Wisconsin Senators Kohl and Johnson, as well as with the offices of Wisconsin Representatives Duffy, Ribble, Baldwin, Sensenbrenner, and Ryan and highlighted
three important initiatives supporting medical device innovation:
Support was expressed
for the reauthorization of the Medical Device User Fee Modernization Act
(MDUFMA) and congressional representatives were
urged to get the collaborative Industry-FDA agreement reauthorized before the
previous agreement expired.
Support was also
expressed for the repeal of the Medical Device excise tax. Currently there are five bills circulating
that are looking to repeal said tax; one of which, Authored by Congressman Erik
Paulsen, has 228 co-sponsors in the House.
raised awareness about and recommended that legislators support the American
Medical Isotopes Production Act, which would direct the secretary of DOE to
implement a technology neutral program to evaluate the production of
molybdenum-99 for medical uses. Two
Wisconsin companies, Shine Medical Technologies and Northstar Medical Radioistopes both just announced their
production facilities for molybdenum-99 would be located in Southern Wisconsin
and this legislation would impact them.
FDA speaks at 2011 BioForward Member Meeting
On December 14, 2011, BioForward hosted William H. Maisel, MD, MPH, Deputy Center Director for Science and Chief Scientist of the FDA's Center for Devices and Radiological Health as a speaker and to meet with area bioscience companies at a roundtable. You can view his presentation below on how the FDA is working to facilitate device innovation and bring important public health benefits to patients safely and quickly
BioForward Federal Advocacy Partners:
BioForward also partners with the following national organizations on federal issues:
AdvaMed advocates for a legal, regulatory and economic environment that advances global health care by assuring worldwide patient access to the benefits of medical technology. AdvaMed’s Federal Government Activities
BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO’s Federal Government Activities
MDMA (Medical Device Manufacturers Association)
MDMA, a national trade association that serves medical technology companies, plays a proactive role in helping to shape policy that impacts the medical device innovator. MDMA's Federal Government Activities
PhRMA's (Pharmaceutical Research and Manufacturer's Association) mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by biopharmaceutical research companies. PhRMA’s Federal Government Activities