The U.S. Food and Drug Administration (“FDA”) notified Hemispherx Biopharma, Inc. (AMEX symbol: HEB) (Price: $7.625) in a Notice of Infraction letter dated October 15, 1998 (“Notice”) that its claims of safety and efficacy for Ampligen violate federal drug regulations. The Notice instructed Hemispherx to “immediately discontinue the dissemination of materials that make claims of safety and efficacy for Ampligen.” The Notice also states that the FDA found Hemispherx violated federal drug promotion regulations by claiming Ampligen’s Phase II CFS study showed efficacy and safety.
The Notice cited 22 specific statements published by Hemispherx about Ampligen’s safety and efficacy that violated FDA regulations and were contained in a Hemispherx press release, on its Website and in statements made by Dr. William A. Carter during an investor conference call. The FDA instructed Hemispherx to acknowledge receipt of the Notice by October 29, 1998. In this response, Hemispherx must “describe its plans to discontinue the use of the aforementioned materials and similar violative promotional activities.” Hemispherx must also “indicate the date on which Hemispherx has ceased all violative promotion of Ampligen.”
The Notice states that the FDA has determined “that Hemispherx is promoting Ampligen as a safe and effective drug prior to its approval for marketing. Promoting drugs prior to their approval for marketing violates” federal laws and regulations. The Notice shows that Hemispherx’s claims concerning the results of Ampligen’s Phase II CFS trials and its safety and efficacy are unlawful.
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