Bush Backs Changes On Medical Devices
Tuesday, July 16, 2002
By Marc Kaufman
Washington Post Staff Writer
The Bush administration has embraced controversial legislation that would allow makers of medical devices to hire private companies to inspect their plants and review some of their more complicated applications -- work now done by the Food and Drug Administration.
As part of the same proposal, the companies would provide millions in "user fees" to pay for salaries, computers and operations at the cash-starved FDA center that regulates medical devices and diagnostic equipment.
The administration is promoting the industry fees and regulatory changes as reforms needed to speed FDA review of the products of the fast-growing medical device and diagnostic industries and to bring cutting-edge technologies to patients more quickly. Medical devices are a $78 billion-a-year business whose products include hip replacements, breast implants, diagnostic cameras that can be swallowed, electronics implanted to control blood pressure by computer, telemedicine and DNA-based tests.
The administration and congressional supporters liken their proposals to a bill passed overwhelmingly by Congress in May that raises millions of dollars from industry to speed FDA reviews of new drugs.
But the separate proposal for user fees has become far more contentious, largely because the industry is demanding that its willingness to pay millions in user fees be accompanied by unprecedented concessions by the FDA.
To some critics, including key lawmakers, allowing the outside reviews and inspections that the industry wants would undermine essential FDA authority. Critics worry that outside reviewers and inspectors would be inclined to give more weight to company needs for fast action than to protecting the health and safety of patients. More generally, they see the move as part of a Bush administration effort to reduce the power of government agencies and to help the businesses they regulate.
Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Committee on Health, Education, Labor and Pensions, played a key role in blocking efforts last month to include the medical device proposals in the prescription-drug user-fee bill that passed. Although he supports the proposal for medical device user fees, Kennedy opposes efforts to give companies the right to hire private companies to do what has been FDA work.
"Senator Kennedy is very concerned about the idea of a regulated industry choosing its inspectors and third-party reviewers," said Kennedy's news secretary, Jim Manley. "It's an inherent conflict of interest that could lead to a potential tragedy."
But the proposal has quickly returned -- along with dire predictions of what will happen at the FDA device center if the user fees and other "reforms" are not passed -- and officials said it is being actively negotiated now in the House and Senate. There appears to be strong support in both houses for approving some type of medical-device user-fee program.
Health and Human Services Secretary Tommy G. Thompson announced the administration's support when he told officers of the Advanced Medical Technology Association (AdvaMed) on June 20 that he considered proposals for outside inspections to be "reasonable," and that the third-party review system should be "strengthened."
"At a minimum, a pilot program . . . would vindicate the benefits of third-party inspection while lying to rest the criticisms from some of our Democratic friends that third-party inspections would not be unbiased or scientifically sound," Thompson said.
Under the bills being discussed, the FDA would provide a list of approved private inspection and review firms that medical device and diagnostic companies could select to perform certain duties now handled by the agency. While the companies would directly pay the outside experts for their work, the FDA would retain some authority to oversee the process and overturn the conclusions. The agency has allowed some outside review before on changes to existing medical and diagnostic technologies, but it has never allowed outside firms to do inspections or to review more complex and novel technologies.
Lester Crawford, deputy commissioner of the FDA, acknowledged earlier this month that there is active debate now over expanded third-party reviews and inspections and whether they are "ethical and consistent with the dictates" of the law that created the FDA. But he said there is a "good possibility" that both will pass in some form this summer, along with new user fees. Republican and Democratic staffers in Congress agree that efforts to negotiate a bill are ongoing.
All medical devices and testing technology must be approved by the FDA before they can be sold, and the length of the review process is crucial in getting products to market and convincing banks and venture capitalists to invest.
But according to David Feigal, director of the FDA Center for Devices and Radiological Health, the department has gone from 998 employees in 1996 to 888 today.
Since the number of applications remains high, the length of time between the submission of an application and a final decision to approve or reject has climbed to 411 days for new technologies. He also said that manufacturing plants for makers of medical devices and diagnostic tests are now inspected on average once every five years, rather than the once every two years as required by regulation. Foreign makers are inspected only once a decade, he said.
"We have already gotten rid of the inefficiencies we had," Feigal said. "Without new resources, we won't have much choice but to do less with less."
The financial troubles at Feigal's center are hardly unique at the FDA. Congressional appropriations for the agency are set in agriculture-dominated subcommittees -- where FDA funding has not been a high priority -- and that reluctance has led to industry fee programs to keep the agency adequately staffed.
While there has been some disagreement within the medical device and diagnostics industries about whether to support user fees, they reached a general -- though still evolving -- consensus last month to provide the FDA with $150 million over the next five years.
But according to Stephen Ubl, an executive vice president of the 1,100-member AdvaMed, the main group negotiating with the FDA on the issue, the industry is unlikely to agree to the user fees unless there is regulatory reform as well.
He said that the device industry has generally agreed it is essential to raise funds for the FDA so applications for new products can be promptly reviewed, but he has also concluded that this is the time for agency reforms as well.
"We feel the user fees and third-party reviews and inspections have to be part of the same package," Ubl said. "They complement each other and need to be seen as two sides of a basic reform."
As Ubl and others explain it, the FDA should accept private inspection of some manufacturing sites because the agency doesn't have the manpower to do it. They also say that companies already host a time-consuming parade of private inspectors to meet a range of standards, including requirements by foreign governments that import medical products. In some cases, they say, European plants that make medical products for the U.S. market are already being inspected for the FDA by private European firms.
Third-party reviews of product applications began several years ago but have been limited to uncomplicated revisions of existing technology. The review proposals, first introduced by Reps. James C. Greenwood (R-Pa.) and Anna G. Eshoo (D-Calif.), would significantly expand that list to more cutting-edge products. Increasingly, the job of the FDA would be to oversee the reviews done by the private companies rather than to do the reviews itself.
Some consumer and patient groups that follow the issue say they are alarmed by the proposals, which they say could weaken safety precautions. According to Diana Zuckerman, president of the National Center for Policy Research for Women & Families, the willingness of the FDA to entertain the proposal shows "they don't know a conflict of interest when it hits them on the head."
"These review and inspection companies know that they have to do a certain kind of job to be selected again," she said. "If they reject an application or find problems during an inspection, it's unlikely they'll get chosen the next time, so they have real incentive to overlook a company's problems."
But if opposition to regulatory reform derails the device user-fee bill,
some predict the Center for Devices and Radiological Health will be seriously
harmed. "It's pretty clear now that [FDA] centers without user fees are
languishing," said Pamela Bailey, president of AdvaMed. Without the proposed
reforms and new funds from industry, she said, it will "just fall further
and further behind."
© 2002 The Washington Post Company