Tobacco Documents Online

• • • Times New York, NY Frustration forMedicallnnovators By LAWRENCE M. FISHER Early last year, American Biomed Inc., a small medical equipment com- pany in Woodlands, Tex., filed a Food and Drug Administration application for approval to market a device that would remove cholesterol from clogged arteries by simultaneously grinding up and vacuuming out the fatty deposits. Surgeons who had used it in trials said it worked well. But 18 months later, the company still awaits word on when or even if its product may be sold. It is a limbo familiar to a growing number of makers of medical de- vices, an industry with $40 billion of annual sales and a foreign-trade sur- plus of $4.1 billion. But in their frus- tration, many companies are ship- ping jobs and capital overseas, a re- cent Congressional report states. 'Can't Take It Anymore' "We're having to move out of the United States," said David Summers, chairman and chief scientific officer of American Biomed, a small compa- ny that has other types of medical catheters and vein-clearing devices on the market but sees its future in the cholesterol tool. "We just can't take it anymore." American Biomed has built a man- ufacturing plant in Canada so it can begin shipping its product for clinical trials abroad without waiting for F.D.A. approval. It has also set up a jbTffventure in France to conduct the trials. "The jobs we would have add- ed here will go to Canada and France," Mr. Summers said. The F.D.A., conceding that its regu- latory backlog needs attention, late last week announced new procedures intended to expedite the review and approval process for medical de- vices, a diverse field that includes artificial hips, heart defibrillators, cancer diagnostic tests and surgical tools. The industry considers the measures a good start, but says they do not go far enough. Trying to Set Priorities The agency, however, intent on avoiding future debacles like the faulty Bjork-Shiley artificial heart valves implicated in some 300 deaths, says that the industry will simply have to reconcile itself to a greater Paul Hosefros/The New York Times Dr. Bruce Burlington, director of the F.D.A.'s Center for Devices and Radiological Health, said the public wants closer medical scrutiny of therapeutic devices. He sat next to a model of a new artificial hip joint. degree of scrutiny than in years past. "For a long time, this center fo- cused on making sure we were doing everything to nurture a growing in- dustry," said Dr. Bruce Burlington, who in February was appointed di- rector of the F.D.A.'s Center for De- vices and Radiological Health. But now, he said, well-publicized prob- lems with a few products "have led people to consider that we need a medical component that is an ongoing part of the evaluation of devices." American Biomed is one of scores of American medical-device compa- Continued on Page D5

• S Frustration for Medical Innovators Continued From First Business Page nies that have introduced new prod- ucts abroad. According to a report released earlier this month by the House Subcommittee on Oversight and Investigations, 49 American- made medical devices that remain tied up in F.D.A. review in this coun- try, many of them potentially life- saving products like artificial heart valves and improved cardiac pace- makers, have been approved for sale in Europe, Japan and elsewhere. Not only are sales and jobs being lost to overseas markets, the report says, but many of the small compa- nies that populate the industry may be driven out of business altogether by regulatory delays. The process also means that Americans are de- nied health-care options that could be safer, more effective or less costly than those on the market today. "Doctors and patients in the United States face the daunting prospect of either having to travel to a foreign land to have access to the latest medi- cal technology," the report stated, "or having to accept a less effective and/or a higher-risk treatment for their illness in the United States." Consuming More Time At issue are two types of approval. One is for devices that the makers describe as basically equivalent to products already on the market; if the F.D.A. agrees with the manufac- turer's assessment, the device can quickly enter the market. In each of the last three years, the F.D.A. has received at least 5,700 applications of this type. Traditionally, such review has taken 90 days or less, and at the beginning of 1992 only a handful of applications took longer. But now, about 1,400 of these applications have been pending for more than 90 days. The second type of approval that is A regulatory pendulum swings between speed and caution. drawing criticism involves triuly new devices unlike anything already in medical use. These, submitted at the rate of 60 or 70 a year, face much greater scrutiny that can include clin- ical trials on human patients. In the 1990 fiscal year, 47 devices received F.D.A. approval. In the 1992 fiscal year, which ended last September, only 12 products were authorized. Industry executives say the F.D:A. has grown much more cautious after the problems with the Bjork-Shiley heart valve, the widespread reports of autoimmune diseases in women who received silicone breast im- plants, and the generic drug scandal of the late 1980's, in which some F.D.A. reviewers were found to have colluded with drug manufacturers in fraudulent applications. But the executives and some con- sumer health-care advocates say that under a get-tough policy imposed by David Kessler, the Commissioner of the F.D.A.,the agency has placed so much emphasis on stringent review that it has forgotten that part of its charter is to approve new devices. 'Like a Wrecking Ball' "The pendulum may swing back eventually, but the pendulum at F.D.A. is more like a wrecking ball," said Kshitij Mohan, vice president, scientific affairs, for Baxter Interna- tional's Hospital Business Group, and a former F.D.A. official. "To the pa- tient, the impact may be the same if you deny good technology as if you allow bad technology on the market." At the F.D.A., Dr. Burlington said he was establishing a program to speed review of critical devices. Beginning this week, the F.D.A. is putting in place a sort of four-step weeding-out process that follows sev- eraL of the House subcommittee's recommendations. First, devices that offer new options to patients and phy- sicians will get expedited review, with potentially life-saving devices moved to the head of the line. In the second step, devices will be given priority on the basis of perceived risk; high-risk devices will get more staff attention, while low-risk devices will get less. The third step is to reject applica- tions judged to be incomplete or pro- cedurally troublesome, rather than letting the F.D.A. staff nurse them along, as has been the practice in the past. And finally,yfor any device un- der review for more than 90 days, the maker can request a status report that must be sent within three days. Despite the streamlining, Dr. Bur- lington said the agency would not back away from its stringent stand- ard of review, which he said included judging the medical effectiveness and safety of new products. Types of Testing But device makers fault the medi- cal component of the review process because they say it requires a type of clinical trial more suited to new drugs. Drugs are typically tested in "randomized" trials with thousands of patients; some get the test drug, others a placebo. But manufacturers say such trials are impractical for most devices and impossible for many, like heart pacemakers that require surgical procedures that most physicians would be reluctant to perform on a placebo basis. "They're trying to take a pharma-

• • Status of 1=ood aW Drug Administration apPlkaticrhs for apPrcval of inedical devices in the last thm fiscal years. A Growing Backlog # 1`,i ~a ~ YY f # t. ~ 0 2 4 6 8 10 12 14 .. $O(X~.~FA~d1fYJ!~AUT~110f7 ceutical approach and apply it to de- vices, and it's just not relevant," said Grant Heidrich, a venture capitalist with the Mayfield Fund, who has in- vested in several medical device start-up companies, "We counsel our companies, 'Don't screw around with the F.D.A.; let's move these trials to Europe where there's a reasonable process,' " he said. "That comes up in every board meeting." For those who flee, the idea is not necessarily to forgo the American market altogether - which repre- sents roughly half of the global mar- ket - but to get a start elsewhere, begin selling the product and hope to come back to the United States even- tually to navigate the F.D.A. process. A Question of Motive Dr. Burlington disputed the critics' characterization of the review pro- cess, saying that while the agency is seeking more clinical data, it is not using the same procedures required for drugs. He said that companies might have many reasons to move overseas but that he did not think the F.D.A. was the main one. "If a com- pany says, 'Hey, we've got to move overseas,' well, I just don't see it," he said. The main reason for such moves, he said, might be economic. Not so, said Rob Michiels, presi- dent and chief operating officer of Interventional Technologies Inc., a San Diego-based maker of catheters, which, as with American Biomed's device, are used to clear arteries. "In our case, the manufacturing costs are always higher over there," he said of Europe. "The only consideration is the time delay in regulatory." Interventional's first device was just approved for sale in the United States after two years and two months in review. For its second, a device used in angioplasty, the com- pany got permission to begin clinical trials in Germany within 34 days; the same process took 13 months in the United States. "By the time we're approved in the U.S., that product will have been available in Europe on the free market for three to four years," Mr. Michiels said. Dr. Burlington said morale and ef- The New York Times ficiency had already improved at the agency, noting that it would approve 24 new devices this fiscal year, doubte last year's rate, although still well below the rate in previous years. "I see renewed energy," he said. "I see people being productive." But some industry leaders are more optimistic, too. "My sense right now is that things have changed," said Frank Fischer, president and chief executive of Ventritex Inc., which recently received approval for an implantable electronic device to control overly rapid heart beats. "I'm very encouraged by the words and deeds so far of Bruce Burlington." Alan Magazine, president of the Health Industry Manufacturers Asso=, ciation, the industry's main trade group, says he was concerned that the new weeding-out approach may speed review of a few devices by slowing down others. But he, too, is hopeful that Dr. Burlington can make a difference. "I think he is an honest broker," he said. "He has the luxury of not being part of the past and he i~, realistic about the problems." 0