WASHINGTON _ Centocor Inc. Wednesday praised the FDA forthe way the agency handled its petition to scale back the level ofregulation of in vitro diagnostic (IVD) products including those witha biologics feature. Centocor appeared before the HouseAppropriations Subcommittee on Agriculture, FDA and relatedagencies to comment on the FDA's fiscal 1997 budget request.
The Clinton administration has asked Congress for a $102.2 millionbudget for the agency that features few new initiatives except for alegislative proposal for a device user fee comparable to the onealready levied on drugs and biologics.
Centocor President and CEO David Holvek called his company'sdealings with the agency "a model of how FDA and industry canwork together in a productive and efficient manner."
Centocor, of Malvern, Pa., also made a pitch for a moderate approachto reform the FDA. Recognizing that jurisdiction to write FDAlegislation resided with the Commerce Committee, Holvek urged theappropriations subcommittee members to "use all your significantinfluence to support limited legislative change."
Centocor's request for regulatory relief for its IVD products hasfound a receptive voice in Congress. Legislative languageincorporating its regulatory suggestions have been incorporated intoFDA reform legislation sponsored by Rep. Jon Fox (R-Pa.) and willbe considered by the House Commerce Committee when it takes upFDA reform legislation later this spring.
When Centocor last appeared before Congress it was mired in whatseemed at the time to be intractable negotiations with the FDA overthe appropriate level of IVD regulation. In response to Centocor'spetition to the FDA requesting a classification change, the FDA hasdowngraded tumor market kits from Class III to Class II. The agencyalso has initiated a regulatory proposal to classify analyte-specificreagents as Class I devices.
Centocor's petition is seeking reclassification of its serum tumor kitsused for cancer patient monitoring from the current Class IIIpremarket approval category into Class II called special controls.Class III is generally used by the FDA to regulate new tests andmedical devices which the agency believes raise concerns aboutsafety and effectiveness. Centocor argued in its petition that Class IIIis inappropriate because serum tumor markers have been availablefor 10 to 20 years and have accumulated a good track record of safetyand effectiveness.
Of the 35 IVDs on the worldwide market, six are manufactured byCentocor. Only five of the 35 tests currently are approved formarketing in the U.S. Few manufacturers have applied for FDAclearance because the cost of obtaining regulatory approval is insome cases as high as the revenues the product produces, accordingto Centocor.
Last month the agency published proposed guidelines to regulateanalyte reagents as Class I IVDs that are exempt from 510(k)requirements to demonstrate comparability with products already onthe market. Centocor expects the agency's response to itsreclassification petition will be published in the near future as aproposed rule.
"These changes are consistent with the interests of the FDA, theclinical laboratory and medical professions and patients for whosecare we all share a portion of responsibility," Holvek said.
While Holvek said he was confident that the FDA would act on theproposed rule within 90 days, he urged the subcommittee to prod theagency to give Congress its timetable for implementing its plannedregulatory changes for IVDs and tumor markers. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.