Medical Device Daily Washington Editor

The Government Accountability Office recently published an analysis of FDA's foreign inspection program for pharmaceutical plants and surprised nobody with the conclusion that the agency's foreign inspection program is in need of an upgrade.

According to the Sept. 22 report — which GAO did not publish on its site until Oct. 22 — FDA's databases of foreign drug manufacturing establishments "contain divergent estimates" of the numbers of plants that are subject to inspection. The database listing plants registered to market drugs to the U.S. is said to include "about 3,000" whereas the agency's database of plants that are registered as having actually shipped drugs is more than double that number, about 6,800.

GAO states that "FDA inspected 1,479 foreign drug manufacturing establishments from fiscal years 2002 through 2007," and at the clip at which FDA was inspecting those plants last year, "it would take the agency more than 13 years to inspect these establishments once." Domestic plants, the report notes, are inspected "about once every 2.7 years."

GAO acknowledged that "FDA made progress in fiscal year 2007 in conducting more foreign inspections," but pointed out that those inspections have covered only about 11% of such establishments.

The GAO report also indicates that FDA's follow-up for warning letters to these plants is in need of a boost. Between fiscal years 2002 and 2007, "FDA issued 15 warning letters to foreign establishments," but caught up with only four of them within five years, "generally because these establishments were named in new drug applications." Three of the four had corrected the problems noted in the first inspections, but acquired new GMP problems in the meantime.

Problems arising with surgical mesh

FDA published a public health advisory earlier this week to warn doctors that surveillance data indicate a substantial problem with surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The Oct. 20 advisory states that the agency has received more than 1,000 reports over the past three years involving meshes made by nine manufacturers.

The notice states that the complications, "although rare ... can have serious consequences," including erosion of the mesh through the vaginal epithelium as well as "infection, pain, urinary problems, and recurrence of prolapse and/or incontinence." The notification also states that FDA has received "reports of bowel, bladder, and blood vessel perforation during insertion," which in some instances have necessitated a procedure to remove the mesh, intravenous blood therapy, transfusions and drainage of hematomas and abscesses.

FDA indicated that the data have not revealed "specific characteristics of patients at increased risk for complications," but some of the risk indicators may be the size and shape of the mesh as well as the material of which the mesh is made. Estrogen status is also a possible factor. The agency recommends that doctors "obtain specialized training for each mesh placement technique and be aware of its risks" and to be "vigilant for potential adverse events."

The agency also recommended that providers inform their patients that the surgical mesh "is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication."

AHRQ: Hospital discharges still in need

Patients are said to be spending less time in the hospital nowadays, but the Agency for Healthcare Research & Quality recently published information that suggests that a patient who is done with the hospital is not necessarily done with healthcare for that episode.

According to recent data provided by the Hospital Cost and Utilization Project (HCUP), the rate of patients discharged from hospitals who nonetheless needed home healthcare rose 53% between 1997 and 2006, although the press accounts estimated this increase as a jump from 2 million to 4 million patients. The HCUP report also shows a 30% increase in the rate of patients discharged to nursing homes or rehabilitation facilities over that same period.

Other numbers from the report help explain the increasing need for post-hospital care. The report says "the average length of stay in 2006 was 4.6 days, almost 20% shorter than in 1993, when the average was 5.7 days." However, that entire decline took place before 2000.

The report blended some good news with some bad news. The rate of hospitalization was said to have flattened between 1993 and 2006 at about 132 per 1,000 U.S. residents, the report noted, but the increase in population over that time pushed the total number of hospitalizations from 34.3 million to 39.5 million.

The report informs readers of something that any cardiologist already knows: that circulatory system diseases account for the largest percentage of all hospital admissions at 16%. Coming in second and third are pregnancy/childbirth and neonatal care at 12% and 11% respectively.

The obvious question for a healthcare economist is "where does the money come from?" According to AHRQ, Medicare and Medicaid "assumed fiscal responsibility for 57% of all hospital stays in 2006," (Medicare accounted for 37% and Medicaid, 20%). Private insurance covered another 34%, while other insurers and those who lacked any form of coverage totaled the balance of roughly 9% between the two.

Despite all the noise surrounding deaths in the hospital, the HCUP report also noted that the number of patients "who died while in the hospital fell from 852,000 to 805,000 — a 5% decrease," between 1996 and 2007.

Janet Trunzo, executive VP for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington) said in a statement e-mailed to Medical Device Daily that the association "believes inspections are a core function of FDA and that Congress should provide appropriate funding for the agency to meet inspectional responsibilities."

Trunzo also said that the agency's "current risk-based inspection approach appropriately targets inspectional resources to those products which are expected to have the greatest impact on public health and safety," and that AdvaMed believes FDA should increase its efforts to harmonize its inspectional requirements with those of other developed countries by recognizing the international quality systems standard ISO 13485."

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