GAO Calls for Improved Recall Procedures from the FDA

The U.S. Government Accountability Office (GAO) is demanding that the U.S. Food and Drug Administration (FDA) revise and improve its medical device recall procedures. The GAO, the investigation arm of Congress, released a 57-page report on June 21 stating that the FDA “has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. The FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices.”

The FDA issued seven high-risk device recalls in June. Following the release of the GAO report, the FDA released a written statement claiming it launched a program in November designed to improve recall notification and classification and educate the industry about the process. The agency also is preparing guidance for release later this year that will clarify the factors that determine a recall. In addition, the FDA said it has “long used recall data to identify poorly performing devices and device types, as well as to identify manufacturers that do not reliably produce safe and effective products.”

Specifically, the GAO wants the FDA to better identify risks to patients, clarify its recall procedures and assess whether actions taken are sufficient and preventative in a more timely manner. Neglecting to make these changes may increase the risk of unsafe medical devices remaining on the market, according to the GAO.

According to the report, the medical device industry initiated 3,510 recalls between 2005 and 2009—an average of 700 per year. Forty percent of those recalls were for cardiovascular, radiological or orthopedic devices. Eighty-three percent involved Class II medical devices, representing what the FDA classifies as a moderate health risk to patients, while 14 percent involved high-risk Class III devices such as pacemakers.

“Several gaps in the medical device recall process limited firms’ and the FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective way and timely manner,” the GAO said in the report. “For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.”

As a result of these challenges, FDA officials examining similar situations can reach opposite conclusions regarding recall effectiveness, the report noted.

“We found FDA lacks specific criteria for making decisions about whether recalling firms have adequately completed their recalls—a key oversight activity of the recall process,” the report stated.

The GAO also concluded that on average, the FDA took 192 days to terminate a recall after it was completed, which is more than twice the time outlined in the FDA’s own procedures. For Class I recalls, the average was 250 days.

The GAO further claimed that the FDA could not provide “definitive answers” about the common cause of recalls, trends in the number of recalls over time, the variation in the numbers of recalls by classification levels, the types of devices and medical specialties of devices that account for most recalls, or the length of time firms need or use to complete recalls.

In a hearing before the Senate Special Committee on Aging, the GAO’s healthcare director, Marcia Crosse, claimed the FDA’s oversight of medical products has been on the GAO’s list of high-risk areas since 2009, after the organization discovered the FDA was weak in both premarket review and postmarket surveillance.

MCRA Offers Compliance Hotline for Ortho Clients

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has launched a Compliance and Business Ethics Hotline, which is designed to help clients maintain a corporate culture committed to ethical behavior.

“The availability of a confidentialreporting system is an essential part ofan effective compliance program,” said Christopher Gingras, vice president of healthcare compliance for MCRA. “The Hotline provides additional comfort to employees seeking to do the right thing by raising an issue.”

The hotline allows employees, contractors, suppliers or other key stakeholders of MCRA’s healthcare compliance clients to anonymously raise issues that adversely could affect employees, customers or the organization, and provides a confidential way for MCRA’s clients to obtain information about compliance issues and report instances of suspected non-compliance outside the normal chain of command. MCRA’s compliance hotline is implemented through a secure, customized Web-based reporting solution. Trained support staff will manage the hotline and be available during normal business hours through a toll-free phone number.

“Our goal with this service is simple: to create systems and processes to help our clients reduce compliance risks by identifying and responding to issues in a timely manner,” said David Lown, general manager of the Washington, D.C.-based firm.

FDA Raises Red Flags AboutSurgical Mesh Use in Women

Women who have vaginal surgery to fix a common gynecologic problem, called pelvic organ prolapse (POP), could experience serious problems if mesh is used to repair it, according to a safety communication released by the U.S. Food and Drug Administration (FDA).

The letter urges patients and surgeons to consider other options. The agency will hold an advisory committee meeting in the fall to determine whether to ban the mesh. More than 100,000 women a year with POP are treated with plastic mesh, but in most cases, the agency said, the condition can be treated successfully without mesh.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., MPH, deputy director and chief scientist of the FDA’s Center for Devices and

Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant—complete removal may not be possible and may not result in complete resolution of complications.”

In 2008, the FDA announced that “rare” problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they’ve been lifted back out of the vagina where they descended. Mesh-related problems include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure. Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. Less commonly, the mesh becomes so intertwined with scar tissue that it can’t be removed surgically.

The FDA cited studies showing thatabdominal mesh repair for POP led to vaginal erosion in 4 percent of women within 23 months of surgery.

Even with the FDA’s recent announcement, surgeons still can opt to use the mesh for vaginal POP repair. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

The FDA cleared the first surgical mesh product specifically for use in stress urinary incontinence in 1996 and for POP in 2002.

FDA’s Chief Counsel Leaves Agency

U.S. Food and Drug Administration (FDA) Chief Counsel Ralph Tyler is leaving the position he has held since January 2010. Margaret Hamburg, FDA commissioner, sent an email informing the agency of this development on June 30. Tyler’s last day was Aug. 5.

Prior to joining the FDA, Tyler served as Insurance Commissioner of the State of Maryland, as well as counsel to Maryland’s governor, Baltimore city solicitor and Maryland deputy attorney general. He previously was a partner at Hogan & Hartson, L.L.P. Tyler’s law experience spans more than 35 years, and he has focused primarily on civil litigation and administrative law. Tyler received his bachelor’s degree from the University of Illinois in Urbana, juris doctorate from Case Western Reserve University in Cleveland, Ohio, and his master of laws degree from Harvard University in Cambridge, Mass.

There has not yet been word regarding Tyler’s future plans. When it initially was announced that he had accepted the position of chief counsel in December 2009, he said that doing so allowed him to “return to being a lawyer.”

Elizabeth H. Dickinson, associate chief counsel for drugs in the Office of Chief Counsel, has assumed Tyler’s position until a permanent replacement is found. Her appointment was effective Aug. 7.

Medtronic’s Infuse Comes Under Fire; Senate Investigates

A spine product from the Spinal and Biologics division of Medtronic Inc. is drawing Capitol Hill scrutiny. The company is under investigation for its Infuse bone graft product—recombinant human bone morphogenetic protein-2 (rhBMP-2)—approved by the U.S. Food and Drug Administration (FDA) in 2002 for spinal fusion surgery in the lower back.

The investigation was launched by the U.S. Senate Finance Committee after reports surfaced that physicians with financial ties to Medtronic failed to reveal the complications in company-sponsored research papers about clinical trials between 2000 and 2009.

The complications were published in the Journal of the American Medical Association last year and in the June issue of The Spine Journal.

Members of the Finance Committee contacted Medtronic in June and demanded an extensive list of documents, including financial records and communication between the company and the doctors who received royalties and other payments from Medtronic over the last decade. A letter signed by the committee’s chairman, Sen. Max Baucus (D-Mont.), and senior member Sen. Chuck Grassley (R-Iowa), warned Medtronic against destroying or hindering the accessibility of any documents, data or other related information.

In a prepared response to the committee, Omar Ishrak, Medtronic’s newly appointed chairman and CEO, said: “While The Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold. Based on that data, we believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications.”

According to The Spine Journal, the rate of adverse events associated with the use of the device in spinal fusion ranges from 10 percent to 50 percent, depending on the approach. Additionally, there is a 40 percent greater risk of adverse events with rhBMP-2 compared with controls in the early postoperative period, including life-threatening events after anterior cervical fusion, according to the study.

“For several years Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies, and strive to lead the industry in ethical and transparent business practices,” Ishrak concluded.