WASHINGTON _ A federal investigation of FDA oversight ofMonsanto Co.'s promotional activities for bovine somatotropin(BST) concluded that the agency needs to tighten and clarify itsregulations for animal drugs. The report, prepared by theDepartment of Health and Human Services Office of InspectorGeneral (OIG) and released on Monday, was requested by Rep.Bernard Sanders (Independent-Vt.).Federal regulations specifically prohibit a drug sponsor, "or anyother person acting for the sponsor," from claiming that a drug issafe and effective for a given use before receiving FDA approval.But according to the OIG report, the law does not provide criteriadirectly defining pre-approval promotion and allowable activitiesfor animal drugs.The OIG report recommended that the FDA define which pre-approval promotional activities sponsors can conduct in compliancewith federal laws and that it increase the "prominence" of theregulations (by use of a subhead in the statute's text). In addition,the OIG said that the FDA should provide its Center for VeterinaryMedicine's (CVM) surveillance division with criteria, formalguidelines and policies.FDA spokesman Jim O'Hara told BioWorld that the FDA has beenrevising regulations for investigational new animal drugs (21 Codeof Federal Regulations, section 511) since 1990. The FDA's currentworking draft regulation contains a separate subsection on thepromotion and distribution of investigational agents. In addition, thenew draft law provides concrete examples of allowable activities.BST, a recombinant form of bovine growth hormone, was approvedby the FDA in November 1993 after more than a decade ofregulatory review and public controversy. Monsanto did not launchthe product in the marketplace until March 1994.In 1991, an OIG report suggested that materials distributed byMonsanto, other BST sponsors and a veterinary drug trade groupconstituted pre-approval promotional activity and required"corrective action." FDA's CVM concurred. Monday's OIG reportrevisited the issue and examined CVM's scrutiny of Monsanto-sponsored activities between 1991 and 1993.Three Activities ScrutinizedThe nine-month OIG investigation focused on three Monsanto-sponsored activities between March 1991 and October 1993:* In December 1992, a market research consultant contracted byMonsanto conducted focus groups with dairy farmers in California,Washington and Florida. The farmers were paid $100 to discuss aproposed BST product and were given handouts with data showingthat BST did not affect the incidence of udder infections and that itwas effective in increasing milk production. CVM wrote a letter toMonsanto in January 1993 which stated that while "termination [ofthe market research] was not legally required," discontinuation ofthe sessions was "prudent." Monsanto agreed to cancel five plannedmeetings.* A video, "BST and Milk: Issues and Answers," was produced byMonsanto in December 1992 in cooperation with the AmericanMedical Association. The video featured experts and researchersdiscussing the safety and effectiveness of BST and was to be shownon cable television following FDA approval. However, oneunauthorized copy of the video was released prematurely. CVMrecommended that Monsanto better safeguard the video'sdissemination before product approval.* In January 1993, Monsanto representatives spoke at a LouisianaState University (LSU) dairy industry seminar and used slides andliterature about the safety and effectiveness of BST. In this instance,CVM advised Monsanto to examine information disseminationguidelines and to take steps to "preclude further objectionableactivity."The OIG report found that CVM policed Monsanto's pre-approvalactivities appropriately, except in the case of the LSU seminar. OIGargued that "CVM had a legitimate basis for sanctioning Monsanto"and that a formal "warning letter" should have been issued. "Webelieve that [CVM] inappropriately excused violative activitieswhich took place at the LSU seminar," the OIG report concluded."Monsanto was obviously willing to break the law, repeatedly, inorder to push this synthetic hormone onto the market and into ourmilk supply as fast as possible," Rep. Sanders said on Monday. "Itis one more reason not to trust them and it is further proof of howcorporations like Monsanto get away with manipulating the FDAand the public."He also said that while current guidelines make it difficult to punishcompanies for violations of pre-approval promotional regulationsafter a product is approved, "some type of action should bepossible." Sanders has also initiated a General Accounting Officeinvestigation of potential conflicts of interest and bias in the FDA'sreview of BST. Results of that investigation are expected soon.Monsanto spokesman Tom McDermott told BioWorld that FDArules for pre-marketing activities are ill-defined. "The lack of claritywas made worse by the fact that there was an unprecedented levelof interest and debate about our product before it was approved," hesaid. "Our opponents were unrestrained in the information theycould disseminate while we were restrained, but in unclear ways."He added that Monsanto was "under a great deal of pressure to talkabout and defend BST" before it won FDA approval. "Between1991 and 1993, [OIG] found only three instances to cite eventhough there was an unbelievable amount of public discussion ofthe product. Any reasonable person would conclude that we did agood job." n

-- Lisa Piercey Washington Editor

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