KEEPING CURRENT

PHARMACEUTICAL

FDA Seeks Stricter Guidelines For Advisory Approval Panels

The U.S. Food and Drug Administration (FDA) has proposed guidelines intended to reduce conflicts of interest among the people who approve drugs and medical devices.

The new rules would disqualify doctors and scientific researchers from serving on FDA advisory panels if they have received financial benefits exceeding $50,000 from drug and medical device companies over the course of a year. Members of Congress and consumer groups have been pressuring the FDA to curb the drug industry’s influence over drug approvals and product labeling in the wake of media reports of gifts showered on doctors and scientists by drug and medical device makers.

Advisory panels have the power to help potentially life saving products achieve FDA approval, and those approvals, in turn, can lead to billions of dollars in revenue for the companies that manufacture the products. Such panels also advise the FDA on product safety and suggest wording for warning labels on prescriptions.

Generosity from drug and medical device makers to doctors and researchers has come in the form of ski and resort trips, as well as five-figure unrestricted educational grants. The FDA also cited other potential sources of conflict, including stock ownership and consulting arrangements.

In one high profile example, an analysis by the Center for Science in the Public Interest in Washington found in February 2005 that most of the FDA’s advisers who had been partly responsible for keeping Merck & Co.’s Vioxx painkiller on the market two years ago had various financial ties to drug makers.

Merck withdrew the drug in September 2004 because of heart related risks.

Under the FDA’s proposal, only individuals with no potential conflicts of interest would be eligible to fully participate in advisory panel meetings as voting members. Panelists who received gifts worth less than $50,000 from manufacturers could receive waivers from the conflict rules, but only if they have unique qualifications or if it is difficult to find experts without financial ties. Committee members with financial interests exceeding $50,000 could be cleared by the FDA commissioner to participate in limited cases.

“The leadership at the FDA is now acting in the public interest,” said U.S. Rep. Maurice Hinchey, who has been pushing legislation in Congress to curtail FDA advisory panelists’ conflicts of interest.

“By ending the practice of allowing FDA advisory boards to be filled with voting members who have financial conflicts of interest, the agency is taking an important step toward ensuring that the only interest advisory board members have when voting to approve a drug or device is that of the health and safety of American consumers,” Hinchey said.

The FDA says it already screens prospective advisory committee members, but the proposed guidelines would bring consistency to its process.

The Pharmaceutical Research and Manufacturers of America, a drug industry lobby group, said it plans “to respond in depth” to the proposal but has only begun reviewing it.

Consumer group Public Citizen, long a critic of the FDA and its relationship with industry, said the agency’s new draft guidance is an admission that its drug approval process is “tainted,” said Peter Lurie, deputy director of Public Citizen’s health research group.

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TESTING

Faulty Car Seat Tests Prompt Magazine Response

Following a botched report on infant car seats that prompted a public apology, Consumer Reports announced it is changing some internal procedures and policies.

In early January, the magazine released crash test results that said 10 out of 12 infant car safety seats provided inadequate protection in side impacts. Consumer Reports later received information from the federal government’s National Highway Traffic Safety Administration (NHTSA) that called its infant seat tests into question.

On Jan. 18, two weeks after announcing the test results, Consumer Reports said the side impact test had been performed incorrectly. The magazine announced it was suspending ratings on the seats and would conduct a review to find out what had caused the problem.

In a March announcement, Consumer Reports blamed a “series of misjudgments” and “miscommunication with an outside lab.”

In the statement, the magazine said the decision to develop its own side impact test without extensive consultation caused most of the problems. Consumer Reports has had a long-standing policy of limiting contact with industry and government officials as a way to protect the independent judgment of its staff.

From now on, Consumer Reports said, it will confer more regularly with outside experts when developing such complex tests. Representatives from the magazine said they will also refine procedures for working with outside laboratories. While the magazine performs most of its own tests, 11% of the tests it ran last year involved outside labs with special equipment or expertise.

In some situations, outside consultants with special expertise in the subject area in question will be hired to review outside labs’ tests and results, the representives said. Tests will be rerun at a separate lab if deemed necessary, and the magazine will prominently disclose whenever tests are performed by outside laboratories.

Kenneth Digges, a former director of Vehicle Safety Research for NHTSA, and Brian O’Neill, former president of the Insurance Institute for Highway Safety, conducted the review to determine the problems with Consumer Reports’ tests. The two reviewed documents and communications regarding the test and interviewed staff at Con-sumer Reports and the laboratory in which the tests were run.

Consumer Reports said it does not plan to perform further side-impact seat tests until there is greater consensus among experts as to how they should be conducted.

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CAPITAL

Bill Would Ease Baldrige Award Limits

A bill recently introduced in the U.S. House of Representatives would ease restrictions on the number of Malcolm Baldrige National Quality Awards that can be given in a year. Congress-woman Eddie Bernice Johnson is sponsoring the bill.

Currently, a maximum of three awards can be given in each of Baldrige’s six categories: manufacturing, small business, service, healthcare, education and the new nonprofit category. Johnson’s bill proposes a maximum of 15 total awards, without any caps for individual categories.

The number 15 was agreed on by Baldrige program director Harry Hertz and the House Committee on Science and Technology, which helped introduce the bill along with Sellery and Associates, the firm that represents ASQ in Washington. That agreement was made before the nonprofit category was approved. According to Sellery’s Amy Kimball, if the bill moves forward, its proponents plan to increase the number to 18 to account for the nonprofit category.

The reason for the bill, according to Kimball, is that deserving organizations have been denied Baldrige awards because of the category caps. The number of applicants in the healthcare and education categories has seen a significant increase in recent years, and the category caps have led to applicants’ “competing within categories rather than for the award,” she says.

Kimball says there is no word yet on whether the bill will get a hearing.

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ASQ News

MEMBER WINS TAG AWARD Technical advisory group (TAG) 176, the body responsible for writing the ISO 9000 series of standards, has given its outstanding professional achievement award to ASQ member Paul Palmes for his contributions to the group. Palmes is the vice chair of TAG 176. Wayne Voorhees, president of Northern Pipe Products, Palmes’ former employer, received TAG 176’s outstanding sponsor award.

INTERNATIONAL MEMBER EARNS CENTURY CLUB AWARD Evandro G. Lorentz, an ASQ member since 1994, is the latest to join ASQ’s Century Club. ASQ members become part of the Century Club by recruiting 100 new members. He will receive a crystal award. With the addition of Lorentz, the Century Club has 54 members. Lorentz lives in Belo Horizonte, Brazil, and has worked at Usiminas Group, a steel manufacturer, since 1979. For more information about the program, go to www.asq.org/eoro/index.html.

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Short Runs

THE CENTER FOR STUDYING HEALTH SYSTEM CHANGE (HSC) says consumer tolerance for inaccurate physician performance ratings varies widely. However, more than one-third of Americans believe such ratings should be no more than 5% inaccurate. The HSC measured consumer acceptance for measurement error in physician performance ratings for four applications. The study’s findings are detailed in Consumer Tolerance for Inaccuracy in Physician Performance Ratings: One Size Fits None, available at www.hschange.org/CONTENT/921 (case sensitive).

RABQSA HAS REMOVED the witness audit requirements from its four main qualification based auditor certification schemes (environment, quality, food safety and occupational health and safety). The recertification criteria have also been revised to reflect the current three-year cycle. For details, go to www.rabqsa.com.

CONSUMERS ADVANCING PATIENT SAFETY has launched a website, www.patientsafety.org, that allows patients and healthcare providers to share information. The site includes a discussion board to facilitate networking, a shared file repository, articles, reports, a book list, and links to other patient safety organizations.

UNDERWRITERS LABORATORIES (UL) will provide Automotive Industry Action Group (AIAG) gap assessment services to automotive parts and accessories manufacturers in China to facilitate North American market access for these suppliers. In addition to performing gap analysis, UL will provide training in problem solving and heat treatment process control. For more information, go to www.aiag.org.

ACCORDING TO A REPORT BY THE JOINT COMMISSION, U.S. hospitals have significantly improved the quality of care provided for patients suffering from heart attacks, heart failure or pneumonia over the past four years. The report details the performance of accredited hospitals against standardized national performance measures and the Joint Commission’s National Patient Safety Goals. Visit www.jointcommissionreport.org to view Improving America’s Hospitals: A Report on Quality and Safety.

A CAMPAIGN TO REDUCE DEATHS and injuries from medical errors in Canadian hospitals is producing “promising results,” says the campaign’s chair. The Safer Healthcare Now initiative is reducing the number of hospital born infections, preventing deaths from heart attacks in hospitals, and lowering hospitals’ overall death rates. The campaign, which centers on saving lives in six medical areas, began two years ago and involves nearly 600 healthcare teams in 180 hospital systems. For more information, go to www.saferhealthcarenow.ca.

THE AMERICAN SOCIETY FOR NONDESTRUCTIVE TESTING (ASNT) has released four new publications related to personnel qualification and certification. The publications cover guidelines for employers to establish in-house certification programs, ASNT’s standard and updated training for certification, and the body of knowledge to be used to train and qualify nondestructive testing personnel. For information, go to www.asnt.org/latestnews/docs2007.htm.

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ASQ

ASQ Team Offers SOX Comments

A team from ASQ’s Sarbanes-Oxley (SOX) Community has responded to calls from the Securities and Exchange Commission (SEC) and the Public Company Accounting Oversight Board (PCAOB) for comments on proposed management guidance rules and accounting standards. The rules and standards cover ways in which public companies are required to exert internal control over financial reporting.

The ASQ team was headed by ASQ Fellow Sandy Liebesman and includes Paul Palmes, John Walz, Donna Spencer and Marty Jaeger.

The proposed SEC rules and PCAOB standards arose from attempts to deal with issues affecting the financial community and U.S. management since passage of the SOX law, which imposed stringent requirements on management for verifying the accuracy of financial reporting.

The requirement that organizations must demonstrate an effective system of control led the ASQ SOX team to research various methods of providing SOX support. After reviewing the Malcolm Baldrige National Quality Award criteria, Six Sigma methodology, ISO 9001 and ISO 14001, the team recommended use of ISO 9000 and ISO 14000.

The structures of ISO 9000 and ISO 14000 are similar to the guidance of the Committee of Sponsoring Organizations of the Treadway Commission (COSO),1 which is used by most organizations to ensure an effective system of internal control. The team also noted that many public companies are registered to ISO 9001, ISO 14001 or both.

SEC and PCAOB are attempting to refocus SOX responses to a risk based, top-down approach, concentrating on the key controls that can indicate the possibility of financial material misstatements. Liebesman says this will reduce the cost of compliance and allow organizations to focus on important business processes. It will also foster the use of quality improvement tools to create more effective operations.

The SOX team looked for ways to build quality methods into the development of financial reports. Review of the SEC and PCAOB guidance publications gave the SOX team an opportunity to specifically include the following key practices of the quality and environmental communities:

• Continual improvement techniques
• The use of data analysis to identify and correct potential risks
• Methodology for ensuring personnel competence
• Controls to manage an organization’s documentation and records
• Clarification of management’s roles and responsibilities

The SEC and PCAOB documents and ASQ’s comments can be viewed at www.asq.org/communities/sarbanes-oxley/abstracts/team-comments.html.

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Note

1. COSO guidance describes five elements of a system of internal control: control environment, information and communication, risk assessment, monitoring and control activities. For the relationship between the COSO guidance and ISO 9001 and ISO 14001 see Sandford Liebesman, “Mitigate SOX Risk with ISO 9001 and 14001,” Quality Progress, September 2005, 91-93.