James Mazzo, president of Santa Ana-based eye device and contact lens care maker Abbott Medical Optics, is continuing his international advocacy for medical devices as chairman of AdvaMed, an industry trade group.
Mazzo and Stephen Ubl, the Washington, D.C. trade group’s chief executive, recently traveled to Tokyo to meet with Japanese officials as part of long-running attempts to encourage Japan’s government to adopt policies AdvaMed says would improve access to device innovations.
AdvaMed made the trip because Japan is one of the largest international markets for many of its member companies and the trade group is concerned about “policies that inhibit innovation in the medical technology industry for both U.S. and Japanese firms,” Mazzo said in a release.
AdvaMed’s meetings with Japanese officials focused on ways that the country could improve regulatory and reimbursement systems, which the group contends delay by several years access to devices that are available in the U.S. and Europe.
Japan is a longtime priority of AdvaMed. Earlier this year, Mazzo said that the group’s efforts helped address aspects of regulation that it felt were inhibiting access to new medical devices.
“AdvaMed was instrumental in bringing to the attention of the Japanese government and people the ‘device lag’—the delay in introducing new products into the Japanese market compared to the U.S. and Europe,” Mazzo said. “This was the result of an approval process that was not working for Japanese patients the way it was intended.”
AdvaMed and the Japanese government teamed up to look at ways to reduce the lag, which ended with the government creating programs to speed up approvals.
But Ubl said that Japan’s device approval process “is still considered the most burdensome in the world” despite the progress.
Ubl added that it was easy to see why AdvaMed members were “increasingly passing Japan by” in terms of doing business. He cited a combination of the regulatory environment as well as what he called “uncertain reimbursement rules” that are based on price comparisons with unrelated foreign markets instead of the costs of doing business in Japan.
Stimulating Software
NextGen Healthcare Information Systems, a subsidiary of Irvine-based Quality Systems Inc., showcased some of its products at a recent users’ group meeting in Orlando, Fla.
NextGen, which is based in suburban Philadelphia, is Quality’s dominant division, accounting for nearly 80% of its yearly revenue of $292 million.
NextGen specializes in software that doctors use to help manage their practices.
During the meeting, the company showcased software that its clients could use for ambulatory and inpatient settings.
Separately, NextGen said that it signed deals with more than 25 federally designated regional extension centers for its Ambulatory EHR electronic health record software.
The company said those deals would allow more than 50,000 primary care doctors to use the software. That would qualify NextGen and its doctors as meaningful users of electronic medical records and allow them to se-cure federal stimulus money from last year’s American Recovery and Reinvestment Act.
Watson Study Falls Short
Watson Pharmaceuticals Inc., a drug maker located just over the county line in Corona, said earlier this month that Uracyst, a treatment it was developing for inflamed bladders, failed to meet the main goals of a pilot study.
Watson was testing Uracyst for interstitial cystitis, an inflammation of the bladder wall.
The drug maker said it was working with Canada’s Stellar Pharmaceuticals Inc. to evaluate the study.
It also said it didn’t plan to spend any additional resources on further development of Uracyst.
“While regrettable, our decision will permit Watson to strategically refocus development resources on other product candidates in our development portfolio,” said Fred Wilkinson, Watson’s executive vice president of global brands.
Watson’s founder, Allen Chao, is a resident of Anaheim Hills. The Chao family is noted for its philanthropy; a cancer center at the University of California, Irvine bears their name.
Bits and Pieces
Irvine drug developer Cortex Pharmaceuticals Inc. and its French partner, Les Laboratoires Servier, announced plans to move into first-phase clinical studies with a jointly developed Ampakine compound. Cortex said in a release that the compound could be used to treat Alzheimer’s disease and other me-mory and cognitive impairments associated with various neurodegenerative diseases … Orange County Emergency Medical Services said that it would transition to electronic medical records from paper patient care records in the next year. The agency received grants to pay for parts of the project, with the Anaheim/Santa Ana Urban Area Security Initiative and the California Office of Traffic Safety providing money … Steven Collis, a former official of Bergen Brunswig Corp., which was based in Orange, is the new president and chief operating officer of its successor company, Valley Forge, Pa.-based AmerisourceBergen Corp.
