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SPORICIDIN ENFORCEMENT ACTIONS: FDA "ACTED CORRECTLY

This article was originally published in The Gray Sheet

Executive Summary

SPORICIDIN ENFORCEMENT ACTIONS: FDA "ACTED CORRECTLY in halting the sale of Sporicidin Cold Sterilizing Solution and disinfectants," the General Accounting Office says in a June 14 report on hospital sterilants. GAO prepared the report at the request of former Rep. Frank Horton (R-N.Y), who asked that the office review regulatory actions against Sporicidin taken by FDA, the Environmental Protection Agency and the Federal Trade Commission. FDA seized the Sporicidin sterilants and disinfectants in December 1991 on the grounds that the products were adulterated and misbranded based on their ineffectiveness and lack of premarket clearance from the agency ("The Gray Sheet" Dec. 16, 1991, I&W-8). Although some Sporicidin products have since been allowed back on the market under a consent decree with FDA, two others remain under seizure. Sporicidin has argued that it has been unfairly singled out for enforcement by FDA. While GAO is generally critical of FDA's regulation of hospital sterilants and disinfectants (see related story, above), the office says that FDA "took proper action against Sporicidin International for not complying with pertinent laws and regulation." "These products were designed to protect patients from serious infections that can result when unsterile instruments are used to treat them," GAO states. "However, Sporicidin Cold Sterilizing Solution did not effectively sterilize medical instruments, and the company had been marketing its products without FDA's prior authorization and failed to register its products, as required by law. Also, FDA inspectors found there were significant violations of good manufacturing practices regarding cleanliness and recordkeeping." In a March 15 response to GAO's draft of the report, included as an appendix in the final document, Sporicidin disputes GAO's finding and characterizes FDA's enforcement actions as "selective" and "arbitrary," claiming that "no other hospital disinfectant was taken off the market even though their products" did not have 510(k) clearance. The report rebuts most of Sporicidin's complaints at some length. For example, the company claims that some of the data used by FDA to determine the effectiveness of the company's products was "faulty." Specifically, Sporicidin questions FDA and EPA reliance on an Association of Official Analytical Chemists (AOAC) sporicidal test, citing an EPA Federal Register notice listing external questions raised about the test, as well as a U.S. District Court judge's commentary in Metrex v. EPA, a dispute involving another germicide manufacturer. GAO, however, found that the Federal Register notice was soliciting research proposals to assess rather than endorse allegations of problems with the AOAC test. In addition, GAO says, "the judge's comments applied only to the performance of a particular test on a specific product and not to the validity of the AOAC test in general." Sporicidin also noted that its products have been registered with EPA since 1976. The GAO report replies that "the registration is not a substitute for FDA's premarket authorization for hospital sterilants because each agency's requirements differ." FDA, for example, requires demonstrations of safety and efficacy "under conditions that simulate actual use," GAO says. On the other hand, "EPA's efficacy requirements can be met with tests that are performed under laboratory conditions." Sporicidin also faults GAO for "[making] an issue about alleged lack of good manufacturing practices," saying that the issue was not included in FDA's original complaint. FDA considered including GMP issues in its basis for sanctions, according to the GAO report, but found sufficient cause from efficacy tests and the germicides' 510(k) status. While the company further notes that EPA inspected its facilities, GAO responds that EPA officials did not conduct manufacturing facilities inspections, nor do they have such authority. Finally, Sporicidin argues that the firm took corrective steps in response to the FDA inspections. However, FDA inspection followup showed that the firm had not corrected all deficiencies cited by the agency, GAO says. Under the consent decree, signed in May 1992 ("The Gray Sheet" May 18, 1992), Sporicidin is prohibited from making claims for its product without supporting scientific data. In February, three products received final clearance as "intermediate disinfectants," which means they are tuberculocidins ("The Gray Sheet" Feb. 15, In Brief). The Cold Sterilizing Solution and Sporicidin HD remain under seizure pending clearance. Currently, according to the GAO report, FDA has not "authorized any Sporicidin products for use as a sterilant." Sporicidin also has settled with FTC that it will not make claims without valid scientific evidence ("The Gray Sheet" Feb. 8, In Brief).
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