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SPORICIDIN SIGNS PACT WITH FDA

 SPORICIDIN SIGNS PACT WITH FDA
 ROCKVILLE, Md., May 18 /PRNewswire/ -- On May 15, Sporicidin


International, the maker of several popular hospital/medical disinfectant products, executed a consent decree with the FDA, "without admitting liability" and "before any testimony was taken," according to Dr. Curtis L. Lynch, vice president/medical director of Sporicidin. The agreement ends the agency's five month activity against Sporicidin for failure to obtain FDA 510(k) market clearances for its products.
 It was agreed that "reconditioning" in the form of a product information sheet conforming to FDA guidance would accompany the Sporicidin Disinfectant Towelettes, Sporicidin Disinfectant Sprays and Sporicidin Disinfectant Solution. Within 48 hours, FDA will issue 510(k) market clearances for these three products.
 According to Lynch, "the FDA claims that all hospital disinfectants are 'medical devices' and require FDA 510(k) market approvals. To date, no disinfectant product on the market has received a 510(k) approval from FDA. Despite this, no product, except Sporicidin has been seized nor condemned by FDA, or taken off the market."
 FDA Commissioner David A. Kessler called this "a bellwether case" to warn other germicide manufacturers to take note. To accomplish this, Sporicidin was effectively put out of business on Dec. 13, 1991, without warning and without a hearing.
 Lynch said FDA was simply using the Sporicidin Company as an example to exert regulatory control against similar firms. The issues raised by the FDA during these actions will affect all companies regulated by the agency.
 Sporicidin has been registered by the EPA since 1976. On Dec. 12, 1991, the day before the seizure, EPA issued a notarized letter stating that Sporicidin is registered with EPA and performs according to the label claims. Ironically, on Dec. 13, the next day, EPA seized Sporicidin products claiming mislabeling.
 On Dec. 13, 1991, in a press release on the day of the seizure, Centers for Disease Control (CDC) stated that there has not been a single case of nosocomial (hospital) infection attributed to Sporicidin in the 14 years it has been marketed.
 Sporicidin's sterilizing claims were confirmed in the EPA laboratory in Beltsville, Md., on two separate occasions, before registration. Also, the U.S. Army Institute of Dental Research (USAIDR) at the Walter Reed Army Medical Center conducted studies which confirmed Sporicidin's sterilizing and tuberculocidal claims. Studies at Johns Hopkins University Hospital demonstrated reuse effectiveness after 30 days.
 Today, all Sporicidin products have valid EPA registrations; yet, in an unprecedented move, EPA ordered a stop-sale without a hearing, coincidental with the FDA action.
 During the past five months, FDA did not produce test data which followed the required Good Laboratory Practices (GLP) that could prove that Sporicidin does not perform according to its label and as registered by EPA. Production of this data was requested from FDA by the court.
 To date, Sporicidin has expended well over $2 million in legal fees and expenses associated with the product recall, required by the government action.
 Robert I. Schattner, president of Sporidicin said, "The company signed the consent decree to avoid prolonged litigation which could last many years." He continued, "It is an incredible burden for an individual, or small company, to emotionally and financially sustain a prolonged government onslaught."
 -0- 5/18/92
 /CONTACT: Dr. Curtis L. Lynch of Sporicidin, 301-231-7700/ CO: Sporicidin International ST: Maryland IN: MTC SU:


TW -- DC015 -- 1316 05/18/92 12:07 EDT
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Date:May 18, 1992
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