WASHINGTON _ A House subcommittee heard testimony onWednesday from representatives of industries regulated by the FDAon how the agency is performing and what level of funding itdeserves.
Centocor Inc. president and CEO David Holveck told members of theHouse Appropriations Committee's subcommittee on Agriculture,Rural Development, FDA and Related Agencies that "a few well-considered, narrowly focused changes" at the FDA could produce"substantial improvements."
FDA Commissioner David Kessler, who was also scheduled to testifyat Wednesday's hearing, has rescheduled his subcommitteeappearance for March 28. President Clinton's proposed budget forthe FDA in fiscal 1996 (Oct. 1, 1995 through Sept. 30, 1996) is $912million, a drop of $9 million from estimated 1995 expenditures.However, expected income from the prescription drug user feeprogram would swell the agency's coffers to slightly more than $1billion for 1996.
Although Republicans have not proposed drastic cuts in FDAfunding, some have been critical of the agency's performance _most notably House Speaker Newt Gingrich (R-Ga.) who has calledthe FDA "the leading job killer in America." Hearings focusing onthe agency's efficiency, or lack thereof, are scheduled for May butthe topic could arise as Republicans ponder the Clinton budgetproposal and question Kessler later this month.
"The FDA is put in a very difficult position and I'm not going to sithere today and bash the FDA," said Holveck on Wednesday. "Theirneed for resources is essential if they are going to keep up withtechnology and do the job they are asked to do."
Holveck praised the FDA for approving his company's drug toprevent blood clotting in high risk angioplasty patients, trade namedReoPro, in less than one year. "I think the process is right," saidHolveck. "The FDA has prioritized and puts important newtechnologies at the head of the line for proper review using expertpeople."
But Holveck, whose company is based in Malvern, Pa., was sharplycritical of the FDA's handling of devices, especially in vitrodiagnostic products. He said that despite spending 10 years and $20million to develop a host of in vitro diagnostics (IVD), Centocor hasobtained FDA approval for only one such product, an assay to detectresidual epithelial ovarian cancer. Meanwhile, the company marketstest kits to monitor (not diagnose) four other types of cancerincluding pancreatic, breast, gastric and lung, overseas.
He said that FDA statutes governing regulation of IVDs are outdated,specifically the rule that IVDs be reviewed under the auspices of apremarket approval application (PMA), used for what are known as"class three" devices. PMAs receive much more scrutiny than classone or two devices, which can be licensed under 510(k) applications.
According to Holveck, the FDA takes an average of 90 days toreview 510(k) applications and an average of "two to three years" toreview PMAs. He urged subcommittee members to consider a set ofspecific legislative action items, including:
* reforming the FDA's premarket review process for IVD productsby reclassifying all IVDs presently deemed class three products asclass one or two products (Holveck argued that class three status isgenerally reserved for products which are internalized, rather thanused outside the body as diagnostic tests are);
* returning to the original statutory requirement for a 90 day reviewperiod for premarket notification;
* changing export regulations to permit manufacturer self-certification and to exempt manufacturers from FDA requirementswhen they export to countries that do not regulate IVDs (such asFrance, Germany and the U.K., to name a few);
* returning to the original statutory definition of "effectiveness" inthe Food, Drug and Cosmetic Act so that premarket review is basedon device "performance" and proposed labeling rather than "vagueconcepts such as clinical utility";
* eliminating joint regulation of IVDs by both Center for BiologicsResearch and Evaluation and the Center for Devices andRadiological Health.
"We obviously have a critical stake in seeing positive, constructiveoutcomes to the ongoing discussion regarding FDA reform,"concluded Holveck. "But rather than contemplating long-term and, insome cases, radical restructuring, we believe that a few well-considered, narrowly focused changes can produce substantialimprovements."
Subcommittee chairman Rep. Joe Skeen (R-N.M.) told Holveck thathis staff would relay Centocor's suggestions to the FDA, elicit aresponse and then organize a meeting with all parties to discussimplementation. "Why should we be shipping products overseaswhen we're in competition with all these folks," said Skeen. n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.