A Medical Device Daily
If you're going to take a bribe, best not try that in China.
News sources reported this week that China executed former State Food and Drug Administration head Zheng Xiaoyu for his role in that country's widely reported product safety problems.
Zheng was sentenced to death in May for taking bribes to approve an antibiotic blamed for at least 10 deaths, along with other "substandard" medicines.
According to the Associated Press, Xiaoyu's execution death was confirmed by State Food and Drug Administration spokeswoman Yan Jianyang at a news conference held to put the spotlight on China's efforts to improve its track record on food and drug safety.
Such cases "have brought shame to our administration and revealed serious problems," Yan said concerning Zheng's guilt and a separate case involving Cao Wenzhuang, the former pharmaceutical registration department director.
Cao was given a death sentence last month, with a two-year reprieve for accepting bribes and dereliction of duty. The AP said that such suspended death sentences usually are commuted to life in prison if the convict is considered to have reformed.
The news service characterized Zheng's death sentence as "unusually heavy, even for China, [which is] believed to carry out more court-ordered executions than all other nations combined." It said the execution "likely indicates the leadership's determination to confront the country's dire product safety record."
Yan said the Chinese FDA was working to tighten its safety procedures and create a more transparent operating environment. But the government acknowledged that its supervision of food and drug safety is unsatisfactory and that it has been slow to tackle the problem, but vowed to improve.
"As a developing country, China's current food and drug safety situation is not very satisfactory because supervision of food and drug safety started late. Its foundation is weak so the supervision of food and drug safety is not easy," the government said in a statement at the start of the news conference.
China has been under pressure domestically and internationally to improve its quality controls after a series of health scares attributed to substandard Chinese products, including exported tainted food and fake drugs. Officials have said the country faces social unrest and a further tarnished image abroad unless it improves the quality and safety of its food and medicine.
Medtronic launches ICD, CRT-D in Japan
Medtronic (Minneapolis) reported commercial launch in Japan of its latest cardiac resynchronization therapy-defibrillator, the Concerto CRT-D, and its latest implantable cardioverter/defibrillator, the Virtuoso ICD.
The company said the Concerto and Virtuoso are the first devices in Japan with wireless functionality, which reduces time needed for follow-ups and procedures; reduction of anti-tachycardia pacing shocks, which minimizes patient burden; and the OptiVol Fluid Status Monitoring diagnostic feature, which allows physicians earlier access to warning signs of deteriorating heart failure, which can then be used for early treatment of the patient's heart failure.
Steve Mahle, president of Medtronic's Cardiac Rhythm Disease Management business, said, "In the past, Japanese physicians often had to wait extended periods of time before being able to offer their patients the newest device therapies such as wireless telemetry. But in working closely with the Ministry of Health, Law and Welfare, we are able to bring these products to market to benefit thousands of Japanese patients with heart failure and arrhythmias."
Calypte test okayed in India
Rapid HIV diagnostic test manufacturer Calypte Biomedical (Lake Oswego, Oregon) said it has received registration and marketing approval for its Aware HIV 1/2 OMT (oral fluid) rapid test in India from the Drug Control Authority of India (DCAI).
Roger Gale, Calypte chairman and CEO, said, "India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the government and private sectors. A Calypte team has just returned from India, where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years."
Gale termed the DCAI approval "a significant milestone in the advancement of our business; a very exciting time for all of us at the company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests."
He said that in addition to creating a distribution network, Calypte plans to establish both research and manufacturing operations in India. "[It] is a logical center for development of Calypte's new products."
Gale said, "While we will initially enter the Indian market with our HIV 1/2 oral fluid rapid test, we are also considering introducing our Aware HIV 1/2 rapid tests using both blood and urine samples to complement the current oral fluid test."
According to 2006 estimates by the National AIDS Control Organization, India has an estimated 2.5 million HIV infections, ranking third behind South Africa and Nigeria for the highest number of HIV/AIDS-infected people. Naresh Dayal, secretary of health and chairman of the National AIDS Control Board, said, "We cannot be complacent. The steady and slow spread of the HIV infection is a worrying factor."
ClearLab technology, other assets sold
1-800 CONTACTS (Draper, Utah) said it has completed the transactions involving sale of its ClearLab (Singapore) business.
The company sold ClearLab's flat pack technology and certain other intellectual property to Menicon , Japan's largest independent contact lens manufacturer, and sold ClearLab's manufacturing, distribution and customer support operations to Mi Gwang Contact Lens , a contact lens manufacturer based in Korea.
CEO Jonathan Coon said, "We received the expected $32 million in cash and $6.5 million in Mi Gwang's stock upon closing these transactions, which will allow us to pay off all of our outstanding debt and capital lease obligations. In addition, we expect to receive from Menicon deferred cash payments of up to $5 million upon Menicon reaching certain milestones, as well as possible earn-out payments over a minimum 15-year term."