GLG News by Cardiothoracic Surgeons (US)

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

IOM Report on the FDA 510k process

August 5, 2011

Analysis of:FDA Reaction to IOM report on the 510k process | www.fda.gov

The long awaited IOM report on the 510k process has created upset in the medical device industry and FDA. The report is a lighting rod in an already tenuous debate over the 510k process. It is not certain the impact this report with have on the FDAs reform of this program.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

More Drug and Device firms partner in research

April 27, 2011

Analysis of:Lilly, Medtronic team up on Parkinson's stragegy | www.reuters.com

For a number of reasons drug and device companies are joining forces to combine their respective technologies to develop new products and new medical treatments. This trend will continue and will require a new kind of regulatory and clinical expertise to successfully commercialize products.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

More drug and device firms partner in research

April 27, 2011

Analysis of:Lilly, Medtronic team up on Parkinson's stragegy | www.reuters.com

For a number of reasons drug and device companies are joining forces to combine thier respective technologies to develop new products and new medical treatments. This trend will continue and will require a new kind of regulatory and clinical expertise to successfully commercialize products.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

FDA over regulation and poor execution

April 14, 2011

Analysis of:High-Risk Medical Devices Fail to Get Adequate U.S. Scrutiny, GAO Reports | www.bloomberg.com

It is no secret that the FDA has upset the medical device review and approval process both in the 510k and PMA pathways. This has resulted in a material disruption in the medical technology sector from VC investments to approval of IDEs and products. This can be attributed to the political quagmire that FDA exists in. The agency is a puppet to the whims of the administration in place and has lacked consistent and qualified leadership for 2 decades.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

JNJ looses control of paradise island

April 3, 2011

Analysis of:UPDATE 1-J&J recalling more Tylenol from closed plant | www.reuters.com

JNJ problems in Puerto Rico operations in the McNeil unit are a clear indication that the management was not paying attention to the importance of FDA compliance and the value of the brand.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

Lilly should merge and focus on combination products

March 24, 2011

Analysis of:Eli Lilly "very much opposed" to merger - CEO | www.reuters.com

WIth the large number of drug companies and less money to pay for healthcare and lower reimbursement rates it makes sense for drug companies to partner with complimentary offerings and when done right will ensure continued grow for both companies in the future.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

STERIS customers get another six months to transition from System 1

March 23, 2011

Analysis of:STERIS customers get another six months to transition from System 1 | www.medcitynews.com

STERIS has been battling issues related to its flagship System 1 device since December 2009, when the FDA issued a safety alert warning that the device could be harmful to patients. System 1 is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

Steris FDA Warning Letter

March 14, 2011

Analysis of:Steris recieved FDA warning letter | www.medcitynews.com

Steris a large sterilization contractor has encountered several compliance issues with FDA who is a key regulator of the companies operations and approvals to market services.Several events over the past year or so have likely strained the relationship between Steris and the FDA — behind closed doors, at least. Most significantly, Steris is still operating in the shadow of events brought on by a December 2009 federal safety alert about its flagship System 1 sterilization device. The FDA warned that the system could cause harm to patients. The company has been working to transition customers to its new System 1E product, but recently downgraded its full-year sales projection due to apparent delays in FDA clearance of an accessory part.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

Med Device Contact Mfg and Contract Sterilization services

March 11, 2011

What is the value proposition for OEMs to use contract mfrs (CMs) and Contract Sterilization (CS) services? The global medical device market is $350 Billion. The Contract Mfg/Outsoucing market is $60 Billion representing about 18%.

Mac McKeenFaculty Director, College of Continuing EducationUNIVERSITY OF MINNESOTA

FDA, Justice Department take action against McNeil-PPC Inc.

March 11, 2011

Analysis of:FDA, Justice Department take action against McNeil-PPC Inc. | www.fda.gov

Charged with manufacturing and distributing OTC drugs in violation of federal law The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs said, "This FDA drug safety enforcement action is aimed at protecting the public health."“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.Manufacturing deficiencies at McNeil’s facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.

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