FDA and Xavier University Team Up for MedCon 2011

On May 3, 2011, FDA and Xavier University in Cincinnati, Ohio will once again team up to hold MedCon.  The goal is to bring together as many members of the global medical device community together to openly dicuss pressing issues facing the industry.  Leading FDA officials and field investigators as well as a number of global industry experts will be in attendance.  MedCon is geared towards medical device companies of all sizes, with a particular eye towards regulatory affairs, quality assurance, research adn development and risk management.

Key speakers include:

  • Bill Maisel, Deputy Director for Science, CDRH
  • Kim Trautman, Medical Device GMP, CDRH
  • Michael Marcarelli (invited), Director of Bioresearch Monitoring, CDRH
  • Christy Foreman, Director oof the Office of Device Evaluation, CDRH
  • Thinh Nguyen, Director of the Office of Combination Products, FDA

Registration is available here.

Lorillard and Reynolds Sue to Halt Regulation Based on Upcoming Report on Menthol Cigarettes

Unsurprisingly, Lorillard, Inc. and Reynolds American, Inc.'s R.J. Reynolds Tobacco Company unit filed suit against FDA regarding an upcoming advisory panel board that will likely recommend a ban on menthol cigarettes.  Lorillard's top seller is the Newport brand and Reynolds sells, among other things, several mentholated versions of its Camel brand cigarettes.  FDA, of course, gained the power to regulate the tobacco industry in 2009 with the passage of the Family Smoking Prevention and Control Act.  Shortly thereafter, on September 22, 2009, FDA banned flavored cigarettes, with a particular eye towards vanilla, chocolate and clove cigarettes.  The ban of the latter raised some interesting WTO issues, but more importantly for our purposes, set the stage for the current controversy.
Although few know exactly what the upcoming Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol cigarettes contains, many expect that the committee will call for an outright ban.  The report is due to be released on March 23, 2011, and in advance of its release, TPSAC will meet twice more in early to mid-March.  Following the report's release, FDA will consider the report and take whatever action it deems appropriate.  With a ban both legally allowable and likely imminent, manufacturers of menthol cigarettes have no choice but to take action to protect their business interests.
In their Complaint, filed in the United States District Court for the District of Columbia, Lorillard and Reynolds have requested the Court to enter declaratory and injunctive relief requiring the defendants to bring TPSAC and the membership of the constituents subcommittee of TPSAC into compliance with the law and to prevent FDA from taking any action based on or influenced by or from making any use of any report provided by TPSAC or the constituents subcommittee as currently constituted.  Specifically, the plaintiffs allege that three of the eight voting members of TPSAC have financial and appearance conflicts of interest and biases that are incompatible with TPSAC's roles as an impartial advisor to FDA.  Substantively, the plaintiffs allege that those three members of TPSAC cannot act objectively because they have all either appeared as paid expert witnesses in litigation against tobacco-product manufacturers or are or have been employed by members of the pharmaceutical industry engaged in the production of nicotine replacement therapy or other smoking cessation products.
While it remains to be seen whether this suit has any merit, at the least, it's sure to impede any further regulation of flavored cigarettes by FDA.  We'll keep our eye on this and do our best to keep you up to date.



Upcoming Meeting and Live Webcast on the Medical Device Innovation Initiative

FDA will hold a meeting on March 15, 2011 in Silver Spring, Maryland about its Medical Device Innovation Initiative.  The purpose of the Medical Device Innovation Initiative is to assure that American patients have timely access to new technologies and next-gen products, while insuring the patient's safety.  This Initiative proposes actions that the Center for Devices and Radiological Health ("CDRH") could take to accelerate and reduce the cost of regulatory evaluation of innovative medical devices.  You may attend, but must register by no later than 5 PM on March 4, 2011.  Alternatively, a live webcast will be available here.


FDA Greenlights Mobile Radiology App

The United States Food and Drug Administration (“FDA”) has recently approved a mobile radiology application for the iPhone, iPad, and iPod touch, all manufactured by Apple, Inc. This application is the first of its kind and is designed to allow physicians to view medical images and make diagnosis based upon the images viewed on the mobile device.

This new application allows iPhone, iPad, and iPod touch users to receive radiology images taken at a physician’s office or hospital that are compressed and sent using software called Mobile MIM, manufactured by MIM Software, Inc. The iPhone, iPad, or iPod touch user is then able to view the radiology images on his or her mobile device and measure distance on the image. The device user is also able to measure image intensity values, and display measurement lines, annotations, and regions of interest.


The FDA evaluated this application by reviewing performance test results, and reviewing results from demonstration studies with qualified radiologists under different lighting conditions. It concluded that although the display performance of mobile devices can vary significantly, a mobile device using this application is sufficient for diagnostic image interpretation under the recommended lighting conditions.


Mobile MIM should be available soon in the United States Apple Store. This application is already available in many countries, including Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, Australia, Hong Kong, Japan, Malaysia, New Zealand, Philippines, Singapore, India, Saudi Arabia, U.A.E, Costa Rica, Dominican Republic, El Salvador, Guatemala, and Paraguay.