Medical Device Daily Washington Editor
The U.S. Department of Justice is making clear that it wants to vigorously pursue theft of intellectual property, and the latest development in this area is that DoJ is assembling a task force to deal with this perennial problem. The most interesting part of the announcement, however, is that the task force lacks representation from the U.S. Patent and Trademark Office.
According to DoJ's Feb. 12 statement, the task force will emphasize "close coordination with state and local law enforcement partners as well as international partners" to pursue IP crime, with a special emphasis on the role of organized crime. The task force will further "serve as an engine of policy development to address the evolving technological and legal landscape" for IP.
The announcement states that the task force will include a host of members of DoJ, including representatives from the offices of senior DoJ officials as well as the FBI and the Executive Office for U.S. Attorneys. But there appears to be no seat at the table for someone from PTO.
Gene Quinn, founder of the web site at IPWatchdog.com told Medical Device Daily in an e-mail: "I am not sure that leaving out the USPTO is at all strange." He said the DoJ effort "will likely be directed at copyrights and trademarks primarily," with perhaps some secondary emphasis on trade secrets.
Quinn noted that PTO "focuses on granting the rights but really plays no role in enforcing the rights," but also observed that PTO director David Kappos serves as the Undersecretary of Commerce for IP, "so he should at least be involved on some level" inasmuch as "ostensibly he is supposed to be the President's top advisor on IP issues."
Victoria Espinel, the U.S. intellectual property enforcement coordinator at DoJ, said in the DoJ statement that the White House "is committed to ensuring that the value created by American workers and enjoyed by communities around the world is protected," adding that the task force "will play a critical role" in efforts to "protect American intellectual property and the jobs that depend on it."
FDA cites snow days for applications
Local school systems in the metro DC area have burned through their allotment for snow days, thus extending the end of the school year for hundreds of thousands of school children across the region. These children and their teachers have company, however, given the delays experienced at FDA in dealing with drug and device applications.
According to the agency's Feb. 13 statement, FDA's campus in White Oak, Maryland, was shut down for four days, between Feb. 8 and Feb. 11, and that the document room at the Center for Drug Evaluation and Research "was closed for an additional day on Feb. 12 ... due to emergency building maintenance." Hence, the agency states that the application review times will be extended accordingly. Drug applications will be extended for five days while those for devices will be stretched out for an additional four days.
FDA states, however, that not all applications "will be extended," although the time and date stamp for received materials will be affected variously from center to center.
AdvaMed Dx adds three member firms
The new diagnostics division opened late last year by the Advanced Medical Technology Association (AdvaMed; Washington) has recruited three new members, making the division a home to more than 50 firms making a living in the diagnostics business.
According to AdvaMed's Feb. 16 statement, bioMerieux (Marcy l'Etoile, France), maker of instruments and reagents for tests for infectious diseases that typically hit hospital patients, is among the newcomers, as is Gen-Probe (San Diego), which specializes in tests and instruments used to a range of sexually transmitted diseases. Rounding out the list of newcomers is Quidel (San Diego), which makes rapid point-of-care diagnostics for infectious diseases and reproductive health.
Scott Garrett, chairman, president/CEO of Beckman Coulter who also chairs AdvaMed Dx, said in the statement that diagnostics firms "face unique regulatory, reimbursement and policy issues and can find the advocacy effort and support they need in becoming part of AdvaMed Dx." Stephane Bancel, CEO at bioMerieux, also said in the statement that his company "look[s] forward to working hand-in-hand with our peers to advance important policy issues facing our industry to ensure quality, innovative products and services to protect and improve health are available to patients around the world." AdvaMed announced the opening of the new division in December (MDD, Dec. 21, 2009).
EMEA meets on CE research
The European Medicines Agency (EMEA; Brussels, Belgium) held a workshop last week with the European Network for Health Technology Assessment (Copenhagen) as the start of "a new collaboration" toward establishing how European authorities "could make a better contribution to the assessment of relative effectiveness by health technology bodies" in Europe. According to the Feb. 16 statement, last week's session was "the first in a series."
The statement notes that relative effectiveness assessments "are increasingly used in the European member states to help policymakers identify the most valuable medicines" and that this collaboration "is in line with a broader initiative" at EMEA "aimed at facilitating access" to comparative effectiveness information by stakeholders. Although the statement offered no details, EMEA indicates that the two bodies "also agreed to explore other areas of possible collaboration or exchange of information in the future."
Device fraudster gets fine, 51 months
Makers of legitimate medical devices sometimes find themselves in hot water with FDA over various claims, but the claims made by those who hawk fraudulent treatments are nothing short of amazing. This was the case with a James Folsom, who was sentenced last week to 51 months in prison and a fine of $250,000, a sum that pales in comparison to the $8 million he is alleged to have robbed desperately ill people of.
According to a statement published by the Office of the United States Attorney for the Southern District of California, Folsom, 69, was found guilty of conspiring to ship adulterated and misbranded devices into interstate commerce. The devices, said to consist of "a micro-current frequency generator with a digital readout," a pair of stainless steel cylinders and two plates wired to the cylinder, were promoted to treat conditions such as AIDS, strokes, ulcers, diabetes and more. Folsom's run at quackery is said to have extended from 1997 to 2008, during which time Folsom employed the name Jim Anderson. The trade names for the devices were "NatureTronics," "AstroPulse" and others.
During his criminal career, Folsom shipped roughly 9,000 units to distributors for $1,000 or more, and charged individuals as much as $1,995 for the bogus cures. Thomas Emerick of the FDA Office of Criminal Investigations, said in the statement that OCI "is fully committed to investigating and supporting the prosecution of those who may endanger the public's health and safety" by "selling unsafe products to be used on an unsuspecting public."
Mark McCarty, 703-268-5690