The U. S. Food and Drug Administration (FDA) must streamline the medical device approval process as best it can while balancing safety concerns, the agency’s newly appointed chief said in her first interview since assuming the post in May.

Dr. Margaret Hamburg admitted to “some problems” at the Center for Devices and Radiological Health (CDRH), the FDA branch that handles premarket approval of all medical devices. In an interview published in the Wall Street Journal, Hamburg promised to address reported discontent at the CDRH, an organization deemed “dysfunctional” and “in meltdown” mode by former FDA Commissioner David Kessler. The two have talked about the discontent among CDRH employees, the Journal reported.

The device center has been a lightning rod for controversy since a group of FDA scientists pleaded with President-Elect Barack Obama in January to restructure the agency. In a letter they wrote to Obama’s transition team, the scientists accused FDA managers of ordering, intimidating and coercing scientists to “manipulate data” during product reviews. The letter’s authors were not reported.

The scientists claimed that CDRH managers “failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently…corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the center director and director of the Office of Device Evaluation.

Under the banner of regulatory ‘precedent,’ managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions that are not scientifically proven and clinically validated.”

Such claims prompted Hamburg to tell reporters in mid-June that she would take a “hard look” at the decision-making within the CDRH and the 510(k) approval process, a system designed to facilitate the sanction of low- or moderate-risk devices that are similar to those already on the market. FDA scientists have claimed the agency gave 510(k) clearance to devices that needed further scrutiny or did not have adequate safety or efficacy data.

While industry groups such as the Advanced Medical Technology Associ-ation (AdvaMed) laud Hamburg’s intentions to overhaul the FDA, they caution that revisions to approval standards could harm patients and companies by delaying the release of new products.

In a statement he released after a June 18 hearing of the House Energy & Commerce Health Subcommittee on medical device regulation, AdvaMed President and CEO Stephen J. Ubl reminded politicians that the FDA’s current approval system has served the public effectively for more than 30 years. Ubl noted that the FDA’s approval requirements are calibrated so the level of regulation is appropriate to the individual device. He also told the Congressional subcommittee members that premarket approval applications for breakthrough medical technology must be supported by “exhaustive clinical and preclinical data that takes years and millions of dollars to gather.” Lower-risk products are subject to a “stringent regulatory framework,” he added.

“Once a medical technology is allowed to go to market, companies must follow strict manufacturing controls to ensure that the devices continue to be safe and effective,” Ubl’s statement read. “These controls are structured so that quality is built into a medical technology at every phase of a device’s life—from design to pre-production to full-scale production to market commercialization. It is important to remember that millions of Americans benefit from advanced medical technologies each year, and the FDA’s regulatory system should continue to ensure that American patients have timely access to life-sustaining and life-enhancing innovations.”

Balancing the need to protect the public from potentially dangerous devices with the responsibility to streamline the review process is not going to be an easy task. But it is one Hamburg is ready to tackle as she assumes the reins of the FDA.

“We cannot allow all of the opportunities in modern science and technology to fade away because the barriers to drug and new product approvals are too high,” she told Reuters in an interview. “On the other hand, we really have a sacred trust with the American people to assure safety. We have a real responsibility to make sure these devices are being appropriately reviewed. I think a proper balance can be achieved.”

Hamburg also said she would work to establish a “global footprint” that would enable the FDA to work with other governments and industries to improve oversight of overseas manufacturing facilities.

Lawmakers Propose Artificial-Joint Registry

Lawmakers in the U.S. House of Representatives introduced a bill in June proposing the creation of a national database of patients who have received artificial hips and knees. Similar systems have been established in other countries to track patient progress and adverse events, with the intent of reducing unnecessary surgeries and flagging possible product defects.

The bill was co-sponsored by Reps. Bill Pascrell Jr. (D-N.J.) and Lloyd Doggett (D-Texas).

“The simple, practical step of registering knee and hip replacement devices ensures not only that patients get the high-quality care they deserve, but also that financial gain never stands in the way of healthy outcomes and patient safety,” Doggett said. “By registering these devices, we can detect problems much sooner than we previously were able. This, in turn, will give patients the peace of mind to know that their knee or hip replacement procedure will not become part of the estimated $700 billion Americans spend every year on procedures that don’t result in better health outcomes.”

The Knee and Hip Replacement Act of 2009 would establish a national registry to collect and analyze data on patients with hip and knee replacements. The registry would be established within the Agency for Healthcare Research and Quality (AHRQ) at the

U. S. Department of Health and Human Services and require the collection of data begin no later than five years after enactment of the law.

AHRQ would work in consultation with the Center for Medicare and Medicaid Services, the U.S. Food and Drug Administration, the National Institutes of Health and the Office of the National Coordinator for Health I.T. to develop policies and procedures for the registry, according to the lawmakers. In order for Congress to adequately oversee the registry’s progress, the Government Accountability Office would be required to submit a report to Congress every other year.

“The Knee and Hip Replacement Act would help ensure that only the best and most effective medical devices are made available to American patients,” Pascrell said. He predicted such legislation would save the taxpayers “billions of dollars.” According to Pascrell’s figures, as many as 18 percent of hip and knee replacements require costly revision surgeries to repair or replace failed devices.

“If America is to be a leader in the medical technology field, it is critical that we take a hard, honest look at how patients are faring and identify any issues that may affect future patients,” he added, noting that he wanted the registry included as part of any healthcare reform legislation.

Patient registries in areas such as orthopedics are expected to play an important role in comparative effectiveness reviews that the Obama Admin-istration hopes will help identify the most effective medical technologies and guide payment decisions for Medicare and Medicaid in an attempt to reduce overall healthcare costs. Industry claims that long-term data for many types of medical devices are difficult and impractical to gather for comparative effectiveness research because medical devices evolve so quickly compared to pharmaceutical treatments.

Implant manufacturers and orthopedic surgeons support the idea of a registry, but are working to create one outside of government and argue that it could be more effective than the legislative proposal.

Pascrell acknowledged the industry’s effort but suggested that the orthopedic industry wouldn’t have the resources to maintain a registry as in depth and broad as the one he has proposed.

The United States is the largest consumer of artificial hips and knees in the world, but it has lagged behind other countries such as Sweden and the United Kingdom in its use of joint registries. Proponents of such registries say that the lack of one in the United States has resulted in an untold number of unnecessary surgeries and the waste of hundreds of millions of dollars.

In a letter sent to Pascrell, the American Academy of Orthopaedic Surgeons (AAOS) said it preferred a privately run registry that would include both Medicare and non-Medicare patients. According to AAOS, non-Medicare patients (younger than 65 years of age) are a large and ever-increasing demographic of hip and knee implant recipients. In the past, AAOS has tried and failed to set up such an independent registry, in part, because orthopedic device manufacturers have been slow to finance it.

CEO Predicts Continued Slowdown of Ortho Market

The slowdown affecting the orthopedic devices market will most likely continue for another few months because people with bum joints are still not financially secure enough to schedule replacement procedures, according to the top official at Smith & Nephew.

Lost health insurance, hefty co-payments and concerns about recovery time (translation: forced time off from work) have slowed growth in hip and knee replacement procedures in the United States so far this year. Overall, the industry is forecasting 2009 growth to be a few percentage points below the typical pace of market expansion, which usually hovers in the high single digits. “That’s pretty much what we’ve seen,” David Illingworth, Smith & Nephew’s CEO, said in an interview with Dow Jones Newswires. “I think we’re going to see a few more quarters of pressure on volumes. I don’t think it’s played out yet.”

What also hasn’t played out yet is people’s attitudes toward their own health. Illingworth believes that candidates for joint replacement procedures will not abandon their quest for new hips or knees. The problems and pain associated with deteriorating joints typically worsen over time, a factor Illingworth claims will enable companies such as Smith & Nephew to recapture many of those postponed procedures.

“I really don’t think that we’re ultimately going to lose those procedures,” Illingworth told Dow Jones. “I think it’s people saying ‘look, there’s uncertainty in my life and this is not the time to be going and taking three months off of work and getting a knee replaced.”

Illingworth’s assessment of the slowdown in the orthopedic devices market is a stark contrast to a report released by Global Markets Direct that forecast an annual 9 percent growth rate in the global joint replacement market through 2012. “The demand for hip and knee replacement procedures is increasing with a rise in the aging population and a growing number of younger patients going for joint arthroplasty procedures,” stated the report, released in December 2008.

“New product innovations, newer procedure techniques and positive clinical outcomes of products introduced in the past four years are some of the key growth drivers in this sector.” While product innovations are certainly key drivers of growth, ground-breaking devices also tend to be expensive, a factor that could work against companies as economic uncertainty lingers andU. S. lawmakers push for healthcare reform. In such a cost-conscious environment, orthopedic manufacturers will have to show that high-priced products also yield premium results, Illingworth said.