PHARMACY

FDA cracks down on consumer scam involving ‘FDA special agents’

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration is warning consumers about a scam to extort money by callers who falsely identify themselves as “FDA special agents” or other FDA officials.

The agency has received several reports of calls enticing consumers to purchase discounted prescription drugs by wiring money to locations in the Dominican Republic. No medication is delivered, but a subsequent call is received from a phony “FDA special agent” saying that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent legal action.

“Impersonating an FDA official is a violation of federal law,” FDA acting associate commissioner for regulatory affairs Michael Chappell said. “The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business.”

The calls appear to be from numbers in the United States, but are actually from cell phones or voice-over-Internet-protocol numbers.

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FDA raises questions about efficacy of pain medication tamper-proofing

BY Alaric DeArment

NEW YORK Questions have arisen as to whether a pill by Pain Therapeutics and King Pharmaceuticals is resistant to tampering.

A memo by the Food and Drug Administration Monday concerns the drug Remoxy, a formulation of oxycodone that uses liquid capsule drug-delivery technology designed to prevent misuse of the drug. Some people have abused oxycodone tablets by crushing them, dissolving it in water and then injecting it for its opiate-like effects.

The FDA’s memo said that Pain Therapeutics did not sufficiently conduct long-term tests of Remoxy to determine whether the oxycodone could be extracted and diverted, though Pain Therapeutics disputes that claim.

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Titan releases earnings report for Q3 2008

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. Titan Pharmaceuticals has released financial results for third quarter 2008.

Total operating costs for the quarter, which ended Sept. 30, were $6 million, compared with $4.6 million for third quarter 2007, the company said. Net loss for the quarter was $5.9 million, compared to $4.3 million last year; losses in both cases totaled 10 cents a share. The increase in operating costs resulted mostly from an increase in research and development funding related to development of the opiate addiction treatment Probuphine (buprenorphine) and a slight increase in general and administrative costs.

“We have continued to streamline our expenses and focus our resources on the phase 3 clinical development of Probuphine,” Titan president and chief executive Marc Rubin said. “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe, and we are continuing these efforts as we evaluate strategic alternatives for the company.”

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