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News and Press: Policy News

Federal Policy Advocacy Alert: April 25, 2014

Friday, April 25, 2014   (0 Comments)
Posted by: Stephen Rapundalo
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IP Protection & Biopharma/Medtech Product Development - Patent Reform, Again
MichBio hosts its next Advocacy Update webinar on Wednesday, May 7, 2014 from 11:00 a.m. - 12:00 p.m. 

Mark Leahey, President of the national Medical Device Manufacturers Association (MDMA) and Hans Sauer, PhD, JD, Deputy Chief Counsel for IP at the Biotechnology Industry Organization (BIO), will discuss the latest on patent reform legislation and attempts to stem abuse by patent trolls. 

Legislative policy efforts are focused in the Senate and have been fairly fluid, but are nearing a final vote. Learn what the proposed patent law changes will mean for your biotech, pharmaceutical and medical device company. Register for the webinar here.

Recap: BIO Legislative Fly-In
The annual BIO Legislative Fly-In took place April 8-9. Approximately three hundred bio-industry executives and leaders converged on Capitol Hill to meet with their state Congressional delegations. MichBio CEO Stephen Rapundalo attended and was joined by Harold Chase, Director of Government Affairs for member company NSF International, and Peter Pellerito, Special Consultant on Economic Development and University Relations for BIO. 

The group met with Rep. Benishek, Huizenga, and Dingell, as well as staff in the offices of Reps. Bentivolio, Camp, Conyers, Kildee, Levin and Rogers, and Sens. Stabenow and Levin. BIO President and CEO James Greenwood, BIO Board Chair Rachel King, and other board members joined the Michigan group in a substantive meeting with Rep. Upton regarding his innovation pipeline initiative among other issues. 

Topics covered throughout the day included proposed cuts to Medicare Part B and Part D, patent reform, Fostering Innovation Act, Small Cap Liquidity Act, and FDA and NIH funding. All in all, it was a very busy day but hallmarked by good discourse and mostly sympathetic ears. 

States Plan Congressional Briefing on NIH
A group of regional life science trade associations including MichBio will conduct Congressional briefings on "NIH, the Life Sciences and Global Health: The Public-Private Partnership." Two briefings are planned, one each for the House and Senate, on May 20. Guest speakers will include representatives from NIH, academia, industry (BD's Accuri Cytometer will be featured), and patient advocacy. The sessions are meant to educate staff and elected officials about the benefits of partnership with NIH and the positive outcomes that public funding for life science research mean to patients.

Draft Guidance on Expedited Access for Premarket Approval of Medical Devices
The FDA announced the availability of a draft guidance document entitled, "Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions." This guidance is intended to outline FDA's proposal for a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA). 

Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to discuss their products. FDA already has a fast-track program for medical devices that are well-established, such as wheelchairs and hip implants. The agency's new proposal is intended to accelerate approval for high-risk devices, generally those that support or sustain life. Devices moving through the new review path would have to be medical breakthroughs or treatments for conditions that have no other treatments.

For more information, please visit the FDA's website.

Submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Docket Number: FDA-2014-D-0363.

Draft Guidance on Balancing Premarket and Postmarket Data Collection for Devices
A draft guidance, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval" was recently posted by the FDA. This draft guidance clarifies current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.  

For more information, please visit the FDA's website

Submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Docket Number: FDA 2014-D-0090.  

FDA-Medicare Concurrent Review Pilot Program for Medical Devices 
This program has been extended and is designed to hypothetically reduce the time between FDA marketing approval or clearance decisions and Medicare coverage determinations. This is done by allowing concurrent or parallel review by these two agencies prior to the product's FDA clearance or approval. Currently, the FDA and CMS approval processes are done in a serial fashion and are handled by different staff.

Medicare is one of the largest payers for medical devices. For new and emerging medical devices, having Medicare coverage approval in place prior to commencing U.S. sales can help to reduce market adoption risk and for privately held companies, may help to substantiate their valuation estimates. 

FDA Transparency and Public Access
FDA announced the availability of a report entitled, "Food and Drug Administration Transparency Initiative:  Increasing Public Access to the Food and Drug Administration's Compliance and Enforcement Data." This report is intended to summarize findings and recommendations from eight FDA working groups established to enhance the transparency and public accessibility of the Agency's compliance and enforcement data.

For more information, please visit the FDA's website.

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