Drug makers are mixed on the effect of user fees paid to the Food and Drug Administration, according to a survey by PriceWaterhouseCoopers International Ltd.
Forty-six percent of respondents don’t think that user fees paid by companies to the FDA have accelerated the review process as touted.
And the FDA hasn’t been clear about the intended purpose of user fees or how they are applied, according to 48% of respondents.
About a third of respondents said they felt user fees were excessive compared to the time FDA staff spends on reviews.
The survey got feedback from 50 makers of traditional drugs, biotechnology drugs, medical devices and diagnostic products.
One of the report’s questions centered on industry perceptions of the Prescription Drug User Fee Act, which was enacted in 1997 and allows the FDA to collect fees from drug makers to help fund and speed up product reviews.
Under the law, regulators can collect as much as $1.25 million per drug application from drug makers.
The current authorization for collecting user fees is set to expire in 2012, unless Congress renews it.
“Clearly, there is a need for better communication between FDA and the industry over the intended use and effectiveness of user fees,” said Joseph Panetta, chief executive of Biocom, a San Diego-based trade group.
Biocom helped develop the survey and distribute it to members.
Other responses included:
• Thirty-eight percent of respondents said they felt that the overall working relationship with FDA has improved in the past two years. Eighty percent said the agency was providing better guidance about its expectations.
• Meeting with the FDA makes a difference—64% of respondents said meeting with regulators before submitting review materials improved the quality of their applications.
• Six in 10 companies expressed frustration that the FDA changed its position during a review. Four in 10 felt some products were denied approvals because of what they termed the FDA’s “inadequate review resources.”
• Companies also feel that the agency’s not doing enough to keep up with advancing technology. Only 8% of drug and device makers thought that the FDA was doing enough to advance personalized medicine, which seeks to use personal details to tailor treatments.
Orange Coast Eye Center
Orange Coast Memorial Medical Center in Fountain Valley signed a partnership deal with the Doheny Eye Institute, which is affiliated with University of Southern California’s Keck School of Medicine.
Doheny is set to open a facility at Orange Coast. The eye center is set to include eight examination rooms and a procedure room for non-invasive treatment. Eye surgeries are slated to be performed in a surgery center that’s in Orange Coast’s patient care pavilion.
Conditions such as glaucoma, cataracts, corneal disease, ocular surface disease, orbital tumors and Graves’ disease are set to be treated by the Doheny Eye Center’s doctors, who are board-certified subspecialists and members of USC’s medical school faculty.
Orange Coast is part of Fountain Valley-based nonprofit MemorialCare Health Systems. MemorialCare also operates hospitals in Laguna Hills, San Clemente and Long Beach.
Quality Systems Executive
Quality Systems Inc., an Irvine maker of software that doctors and dentists use to manage their practices, named James Sullivan as its executive vice president, general counsel and secretary. Sullivan started last month.
He comes to Quality from TriZetto Group Inc., a healthcare information technology company that moved its headquarters from Newport Beach to Colorado last year. Sullivan was TriZetto’s senior vice president, general counsel and secretary.
His background also includes serving as senior vice president, general counsel and secretary of Long Beach Financial Corp., a mortgage lender headquartered in Orange. Sullivan holds degrees from USC and Loyola Law School.
Sullivan’s general counsel role is newly created. He replaces Paul Holt as Quality’s secretary. Holt will continue to serve as the company’s executive vice president and chief financial officer.
Bits and Pieces:
Ista Pharmaceuticals Inc., an Irvine eye drug maker, moved to a new address at 50 Technology Drive in the Irvine Spectrum. The company said that it had outgrown its previous space, which was made up of five facilities and two suites on nearby Alton Parkway. Ista leased its new headquarters for seven years from Irvine Company … Irvine-based ChromaDex Corp. signed a deal with Norway’s Kappa Bioscience AS to supply quality control and analytical testing services for Kappa’s compounds. ChromaDex makes research chemicals and other products for makers of dietary supplements and the food and beverage industry … Newport-Mesa Audiology, Balance and Ear Institute in Newport Beach said that it started a program to treat dizziness, vertigo and balance disorders. It uses Epley Omniax, a device made by Portland, Ore.-based Vesticon Inc.
