Improving America’s Health V— a survey of the working relationship between the life sciences industry and the FDA
This month, BIOCOM and PricewaterhouseCoopers (“PwC”) will be launching a 2009 FDA Survey, entitled “Improving America’s Health V—a survey of the working relationship between the life sciences industry and the FDA.”
The report that results from the survey will provide an in-depth understanding of the interaction and communication between the FDA and the life sciences industry, as well as provide recommendations that can be implemented for improvements around the working relationship between the Agency and the industry.
We believe this survey and subsequent report will be highly valuable to the FDA and to the life sciences community as a whole. BIOCOM urges you and your colleagues to get involved and participate. Please send an email to PricewaterhouseCoopers.and.BIOCOM@us.pwc.com with “Life Sciences FDA Survey” in the subject line to obtain more information on how to participate. Thank you.
Senators Launch Inquiry into GPO Practices
Senator Chuck Grassley, Ranking Member of the Senate Finance Committee, Senator Herb Kohl, Chairman of the Senate Aging Committee, and Senator Bill Nelson, a member of the Finance Committee, sent a joint letter to seven group purchasing organizations to inquire about their contracting practices. In the letter, among other requests, the Senators asked for specific information and documentation relating to the GPOs sole-source contracting practices, specific criteria used in determining contract awards, and a description of practices outside of vendor contracting. The Senators have asked for a response to the request by September 8.
Read More
http://www.nytimes.com/2009/08/14/health/policy/14purchasing.html?_r=1&ref=health
CDRH Director Resigns
FDA Centers for Device and Radiological Health (CDRH) Director Dan Schultz announced his resignation this August from the Agency. Accordingly to the FDA, the decision arrived as a result of discussions between Dr. Schultz and FDA Commissioner Margaret Hamburg. The FDA also acknowledged that the decision was not the result of any specific issue related to the device approval process. Dr. Schultz has worked at CDRH for 15 years and has led the division since 2004.
Read More
http://online.wsj.com/article/SB125002014808123517.html
Senate Panel Examines Device Manufacturer Liability
The US Senate Health, Education, Labor and Pensions Committee held a hearing in August to examine the Medical Device Safety Act (MDSA). The bill, introduced by Committee Chairman Edward Kennedy (D-MA), would, in effect, overturn the Supreme Court’s in Riegel v. Medtronic which maintained the FDA’s position as the final arbiter in determining the safety and effectiveness of a PMA class device. The Panel heard from several experts in the field as well as several patients using PMA devices. MDMA will continue to inform members of Congress about the harmful consequences of this legislation including the likely negative effect upon small businesses.
BIOCOM Public Policy Section Provides Regular Updates on Health Reform Progress
The health reform debate is proceeding at a dizzying pace. In an effort to keep our members informed of the very latest developments, BIOCOM has set up a section on its website which will have news articles that help update you on the status of health reform efforts or bring a new insight into the discussions for our members. The health reform section can be found here:
http://www.biocom.org/public_policy/Health%20Care%20Reform/
If you have questions or suggestions for articles to be included that you have come across, please contact Madeleine Baudoin, BIOCOM Associate Director of Public Policy, at mbaudoin@biocom.org.