A regular topic of discussion for Orange County medical device executives—the speed of Food and Drug Administration regulatory reviews—was the subject of a congressional hearing earlier this month.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told lawmakers that the agency needs more funding to discourage staff turnover and to speed up reviews.
Shuren told members of the House Energy and Commerce Committee that the FDA’s device reviewers are stretched thin with a heavy workload and increasingly complex technologies to evaluate.
“We need to find (the) means to handle an ever-increasing workload and reduce staff and manager turnover,” Shuren told the subcommittee, according to a Reuters report.
It’s unlikely Congress will come up with more funding, Republican lawmaker John Shimkus of Illinois told Shuren.
Other lawmakers asked Shuren to streamline FDA reviewing to help spur venture capital funding and to create jobs.
Industry critics contend that the FDA discourages venture capital investment and threatens jobs with what they consider to be unpredictable and unreasonable demands on companies.
Dissatisfaction with the FDA review process also came up in a February report.
A survey done as part of the California Biomedical Industry Report showed 84% of respondents said the FDA’s regulatory approval process has slowed the growth of their companies.
The report was produced by PriceWaterhouseCoopers, Northern California trade group BayBio and San Diego-based California Healthcare Institute. The survey was done in November and targeted 100 companies.
After a series of high-profile product safety issues, the FDA “has tended to discount benefits compared to risks in ways that discourage innovation,” the report said.
It also said there is evidence that FDA reviewers “have requested increasing amounts of clinical data and have grown more guarded and less communicative in their dealings with industry.”
“Uncertainty and unpredictability” with the FDA has “reached serious proportions” and, among other things, has resulted in a shift of product introductions to Europe, according to the report.
Jim Mazzo, president of Santa Ana-based Abbott Medical Optics Inc. and chairman of Washington, D.C.-based trade group Advanced Medical Technology Association, recently told the Business Journal his company debuts products in Europe first because of quicker approval times there.
Ensign’s Deal Making
Ensign Group Inc., a Mission Viejo-based nursing home operator, has targeted the western U.S. for growth on its own and through acquisitions.
The company’s buying and integration practices were looked at in a recent article on Forbes Media’s Investopedia website.
Author Will Ashworth said Ensign’s business plan is “a good one” because the company buys a mix of well-run and underperforming nursing homes and integrates them before going on another buying spree.
“That’s smart because finding acquisitions is expensive—not to mention time consuming,” Ashworth said. “While acquisitions are an important part of the business, the operations are why they do the deals in the first place.”
Ashworth predicted that Ensign, which has 85 facilities in California and six other states, will add seven facilities this year and 14 next year.
Ensign’s already bought two continuing care retirement campuses this year and said it plans to focus on growing on its own and improving operations.
Questcor Joins Index
Anaheim-based Questcor Pharmaceuticals Inc. recently was added to Standard & Poor’s SmallCap 600 stock index.
Questcor, a maker of drugs for nervous system and inflammatory disorders, is replacing Sonic Solutions, a Northern California maker of DVD-burning software.
Sonic is being bought by Rovi Corp. of Santa Clara.
Questcor, which had a recent market value of about $880 million, makes H.P. Acthar Gel, an injectable drug that’s approved by the FDA for the treatment of 19 diseases.
The drug primarily is used for treating multiple sclerosis in adults and infantile spasms in children younger than two.
Questcor moved to Anaheim from the Bay Area last fall to be closer to the Yorba Linda home of Chief Executive Don Bailey.
Shares of Questcor got a bump earlier this month after S&P’s announcement. Stocks that are added to major indexes generally rise on the news because portfolio managers who track the indexes buy shares.
Bits and Pieces
Irvine medical device maker Endologix Inc. said results from an initial clinical trial for a surgical device used for repairing ballooning blood vessels showed 100% repair was achieved, with no major side effects observed … Renaissance Surgical Arts at Newport Harbor, a Costa Mesa outpatient surgery center, said it began offering intraoperative therapy for women with early-stage breast cancer. Renaissance uses the Intrabeam device, which is made by a unit of Germany’s Carl Zeiss AG.
