FDA Import Crackdown Escalates With DoJ Suit Vs. Canadian Pharmacy Site

FDA is escalating its enforcement against drug reimportation through a Department of Justice suit against a Canadian pharmacy operation.

DoJ filed suit Sept. 11 in the Northern U.S. District Court of Oklahoma seeking an injunction against Rx Depot Inc., Rx Canada, Rx Depot President Carl Moore and Secretary David Peoples to stop importation of prescription drugs.

The states of Oklahoma, Arkansas, and Montana have also taken action against the companies involved.

FDA previously sent a ¹ warning letter to Rx Depot concerning its practices (² (Also see "FDA, Pharmacy Group Discussing Canadian Rxs; NCPA Wants To Ban Ads" - Pink Sheet, 24 Mar, 2003.), p. 8). The Arkansas-based pharmacy was cited for selling Canadian drugs that were mislabeled as "FDA approved" and meeting "FDA standards."

Furthermore, the company's website incorrectly claimed the drugs "are all approved for use by the United States government and are exactly the same as if purchased in the United States."

The companies, which are operated by a father and son, have said that they would continue their activities until ordered by a court to stop.

³ FDA's announcement of the suit said the agency made two undercover purchases of drugs from Rx Depot as part of its investigation of the company. In one case, an investigator placed an order for a 30-day, 60-pill prescription of Bristol's antidepressant Serzone (nefazodone).

The order which arrived "contained 99 pills (and was labeled as containing 100) of a foreign-manufactured version of Serzone, known as APO-nefazodone," DoJ's ⁴ injunction request states.

The excess number of pills was of particular concern, FDA said, because "if the patient took the drug as instructed by the package sent from the Canadian pharmacy, he or she could have an increased risk of liver failure, which might be associated with taking the drug for an excessive period."

FDA's choice of Serzone is noteworthy given the product's regulatory history. Bristol has been in discussions with Canadian regulators over the risk/benefit profile of Serzone and the future of its marketing status there due to increased risk of liver failure and death (⁵ 'The Pink Sheet' Sept. 1, 2003, In Brief). The drug is no longer sold in Europe ("The Pink Sheet" Jan. 13, 2003, p. 23).

The suggestion in FDA's announcement that taking Serzone for more than 30 days without physician consultation could be unsafe appears to go beyond the safety language in the product's labeling.

U.S. Serzone labeling added a "black box" in 2001, and recommended, but did not require, "periodic" monitoring for liver toxicity (⁶ (Also see "Serzone Liver Failure Relabeling Suggests Periodic Testing, Adds Black Box" - Pink Sheet, 10 Dec, 2001.), p. 22).

The other undercover purchase was for Janssen's nail fungal agent Sporanox (itraconazole). That order was apparently dispensed as prescribed, but DoJ's filing notes that the "defendants caused the Sporanox to be shipped back into the United States by a party other than the manufacturer and thereby violated 21 U.S.C. § 381(d)(1)."

FDA has also sent letters recently trying to discourage reimportation activities sponsored by states or municipalities (⁷ (Also see "Public Sector Reimportation Programs Violate FD&C Act, FDA Tells Calif." - Pink Sheet, 1 Sep, 2003.), p. 35).

The agency announcement of the suit includes a list of steps FDA is taking "to help consumers meet their medication needs at an affordable price."

Steps include: (1) reforms to increase the availability of generic drugs; (2) help in using drugs "effectively, and without costly complications," including bar-coding and electronic adverse event collection; (3) reforms in good manufacturing practices; and (4) "assistance in enacting legislation to provide an effective drug benefit in Medicare."

FDA's enforcement push on imports comes as the brand industry is trying to position the reimport debate as a free trade issue, instead of strictly emphasizing safety concerns (see ⁸ (Also see "Rx Pricing Debate Must Be Framed As Trade Issue, Pfizer CEO Says" - Pink Sheet, 15 Sep, 2003.)).

The agency also announced Sept. 9 that it was sending ⁹ warning letters to six firms selling Accutane (isotretinoin) over the Internet. The acne medication, which can potentially cause birth defects, was placed on FDA's import alert risk list in December (¹⁰ (Also see "FDA Puts Accutane On Import Alert Ahead Of Congressional Hearing On Safety" - Pink Sheet, 16 Dec, 2002.), p. 6).