Attendees at last month's annual meeting of the Medical Device Manufacturers Association (MDMA; Washington) were told that FDA staff has done an "outstanding job" of working with industry to create the "least burdensome" draft guidance document the agency released for comment at the beginning of the month. David Link, vice president of ExperTech Associates (Concord Massachusetts), made that comment, adding that, while he has criticized past actions of the agency's Center for Devices and Radiological Health (CDRH), the center is "changing substantially."
A panelist during an MDMA/FDA Tutorial session at the MDMA gathering, Link strongly urged manufacturer input into the draft. "The more support that comes from industry, the easier it is [for CDRH management] to push it to the operating level," he said, a point that drew nods from CDRH officials present at the session.
Building on Link's comments that the "least burdensome" concept "is not well-defined in the statutes." Fellow panelist Joanne Less, PhD, director of investigational device exemption and humanitarian device exemption programs in the CDRH's Office of Device Evaluation, said the guidance document is meant to remedy that.
The FDA Modernization Act was "one of the most sweeping pieces of legislation in the device world," Less said, noting that the law expressed "Congress's goal of increasing access to new technology." Through the least burdensome amendments, injected into the existing law at Section 513, "Congress was telling us to focus on working with the 510(k) and PMA [premarket approval] applications, but there was no change in the statutory thresholds for clearance," that is, no change in "substantial equivalence" or "safety and effectiveness" requirements, she said.
CDRH was initially directed to develop least burdensome guidance without industry collaboration and the first draft, issued in the fall of 1999, "was not well-received," Less said. As a result, "we agreed to work with industry, and a joint working group was established February 2000."
Less said CDRH has taken a potentially narrow least burdensome legal directive and interpreted it as applying to all review activities and to the development of any guidance or regulation. "We are saying it will apply in all our thinking," she noted.
Both Less and fellow panelist Phil Phillips, deputy director for science and regulatory policies in the Office of Device Evaluation, emphasized the importance of having a final least burdensome document in hand before further training of agency staff and panel members. The document calls for FDA and industry alike to take "all reasonable measures to lessen review times," Less observed. In practice, this means, among other things, that FDA staff will "use the phone, use the fax," and resort to writing letters only when the company hasn't responded.
"Unrelated" regulatory business is one of the first items addressed in the new draft, which says that "FDA should generally avoid anything not pertinent to the immediate business at hand during review." That means "not dealing with OSHA requirements, for example," Less said, noting that one FDA reviewer was told, "Companies have to pay their taxes too, but we don't enforce IRS regulations."
When it comes to applying least burdensome concepts to PMAs, the guidance "was changed by senior management," Less said. While the older guidance said that nonclinical data and bench testing could be "considered" during review, the new approach is this: "Where clinical outcome can be predicted from nonclinical data, well-designed bench and/or animal testing can serve as the basis for approval." Here, Less advised, "it helps us [and you] if you use standardized tests rather than making up your own tests. Use a protocol that's well-defined."
She emphasized, "We want to convey that there are lots of options out there" in addition to random controlled trials. In particular, she noted, CDRH director David Feigal Jr., MD, wants to emphasize that "information from earlier versions of a device or marketing experience from similar devices may be used to reduce data requirements" in PMAs, both originals and supplements. He is stressing that "there's a lot of information in the literature and in the public domain that can be used," she told the MDMA attendees.
"We do need to hear from you," she noted, pointing out that comments on the draft document are due by Aug. 1. "Not working with the industry has gone by the boards." To that, Phillips added: "Particularly with least burdensome, it doesn't make any sense." Asked by Link to clarify, given previous FDA resistance and a first draft done by FDA alone, Phillips said, "There is no reason why we can't come together" now.
Help 'fix' HIPAA regulations
The medical technology industry speaking out also was the theme of another session at the MDMA meeting – this one dealing with the privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA). The problem for many in the medical device sector who are working against a 23-month clock to comply with HIPAA provisions is determining whether the rule really does apply to them, said Jeffrey Boothe, partner with the law firm Holland & Knight (Washington).
Boothe, along with Alan Mertz, executive vice president of the Healthcare Leadership Council (Washington), spoke during the MDMA session at the Washington Court Hotel on Capitol Hill. They were quick to point out that the HIPAA rules have not been implemented, so the door remains open for some modification.
In a nutshell, the rules mean that doctors, hospitals, pharmacies and health insurers will have to get written consent from patients before transmitting or using medical information. President George Bush delayed his approval of the Clinton administration-drafted rules until April 14. And when the rules were finally approved, Secretary of Health and Human Services Tommy Thompson said some of the consent rules may be relaxed before full implementation in two years.
"We have to look at what can be fixed and what you can do as an industry to help fix it," Mertz told MDMA attendees. Boothe told the audience members to read the rules and determine if they are a "covered entity" and must comply. Covered entities are defined broadly as health care providers, health plans and health care clearinghouses. The rules call a health care provider any persons who furnish health care, such as physicians, nurses, midwives, clinical laboratories, X-ray facilities and so forth; billing personnel, including care services or supplies related to the health of an individual; and preventive, rehabilitative care, counseling services and those selling and dispensing a drug or device.
Before the rule is effective in 23 months, Mertz recommended that anyone opposed to any part of it should write Congress, President Bush or Health and Human Services. Additionally, he recommended remaining active with MDMA and other industry organizations to stay abreast of developments.
Physicians connecting with web
The days of the technologically challenged physician appear to be numbered. Doctors are gradually becoming more Internet-savvy, according to a study released last month by the American Medical Association (AMA; Chicago, Illinois). The perception of the Internet as a useful resource has steadily increased among physicians since 1997 said the study, and this appreciation has translated into a 50% increase in the proportion of online physicians. The new findings come from a 2001 AMA study on physicians' use of the web which involved interviews with just over 1,000 U.S. physicians between June 15 and Sept. 9, 2000. The newly released survey is the third analysis of nationwide patterns of online physicians conducted by the association.
Major findings of the study included the fact that a considerable increase in the use of computers among physicians has been matched by an equally impressive increase in physician use of the Internet. Computer use among doctors has increased 33% from 1997 levels, with 75% of the physicians surveyed saying they are regular computer users. Web use among doctors has increased 50% from 1997 levels, with over 70% of the respondents reporting web use. The percentage of online physicians that consider the web a useful resource for drug information, business and patient education has increased significantly since 1997. Communication, news and information and drug information were cited as the three most important reasons for accessing the web.
The study found that the top five physician activities on the web have remained unchanged since 1997. These activities included: sending and receiving non-patient- related e-mail; medical information sources; collecting travel information; obtaining product information; and professional association communications. Areas of physician use that have made significant inroads in the past four years included collecting conference information; purchasing products/services; shopping; brokerage services; and online banking.
For the first time, the AMA study examined electronic communications between patients and physicians. The study found that 25% of online physicians use e-mail to communicate with patients.
FDA seeks to boost clinical trial inspections
Bernard Schwetz, acting principal deputy commissioner of the FDA, told a U.S. Senate subcommittee last month that the agency intends to increase the number of annual inspections of clinical trials by more than 23%. Schwetz testified before the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development and Related Agencies, about the FDA's proposed $1.4 billion budget, up $123 million over fiscal 2001.
The budget includes an extra $10 million for human subject protection to increase the number of clinical inspections of high-risk trials from 1,200 to 1,475 per year. Trials considered for inspection would include those enrolling vulnerable populations (mentally retarded, pediatric) and sponsor investigators who have a proprietary interest in the product being studied.
Oversight of human subject protection has become more essential than ever because of the proliferation of multisite clinical trials and the emergence of gene therapy and other technologies, according to FDA. Without an effective independent oversight body, participation in clinical trials may be adversely affected by fewer volunteers, thus stunting new product development and depriving consumers of medical advances, Schwetz said.