WASHINGTON _ The FDA's Division of Drug Marketing,Advertising and Communications (DDMAC) has initiated aninvestigation of Genentech Inc. for possible violations of federalregulations in promoting off-label use of its recombinant humangrowth hormone, Protropin.The agency's action was revealed Monday in a letter written by FDAAssociate Commissioner for Legislative Affairs Diane Thompson onAug. 12 and addressed to Rep. Ron Wyden (D-Ore.), chairman of theHouse Small Business Committee's Subcommittee on Regulation,Business Opportunities and Energy. Wyden requested that the FDAreview Genentech's activities after reading an article in TheWashington Post on March 15 that analyzed physicians' prescribingpractices of Protropin and certain other promotional activities of SouthSan Francisco-based Genentech.FDA spokesman Jim O'Hara told BioWorld that the Post articlebrought to light "new information" which sparked the agency to initiatean investigation, but he declined to specify which specific informationin the lengthy article was cause for concern. An earlier FDAinvestigation of Genentech's off-label promotional activities conductedin March of 1992 did not produce any evidence of wrongdoing.Protropin is approved by the FDA to treat children suffering fromhypopituitary dwarfism and chronic renal insufficiency. However,some have argued that the drug is being used extensively to treatchildren who are merely short even though there is no clinical evidencethat Protropin can make normal children taller. An ongoing NationalInstitutes of Health study is comparing the effects of a placebo andProtropin in short children to test that hypothesis. It will be completedin about 10 years.It is not illegal for doctors to prescribe Protropin for short children, butit is illegal for Genentech sales representatives or any other "agent" ofthe company to promote the practice. In order to prosecute Genentechfor violation of the Federal Food Drug and Cosmetic Act, the FDAmust prove that the company or its agent promoted the drug in thismanner.DDMAC joins a number of federal agencies currently scrutinizingvarious Genentech marketing and promotional activities. Governmentagencies are looking into three types of allegations surroundingGenentech's activities: participation in illegal kickback schemes toinduce physicians to prescribe Protropin, promotion of Protropin fornon-FDA-approved uses and use of a non-profit educational foundationas a marketing tool. So far, the scrutiny has resulted in one federalgrand jury indictment naming a top Genentech executive (but not thecompany itself).A `Bad Model' For IndustryWyden's subcommittee is also investigating the activities of thecompany. Subcommittee staff director Steve Jenning said that hearingswill probably be scheduled before the end of the year. "Taken together,these (government) investigations are national in scope," Jenning toldBioWorld. "If these allegations prove true, it sets up a bad model forthe rest of the biotechnology industry."The company maintains that it has engaged in no improper activities."Genentech's marketing and educational efforts help medicalprofessionals bring the benefits of our pharmaceuticals to their patientswho need them and fall within accepted industry guidelines set forth bythe AMA (American Medical Association), the PMA (PharmaceuticalManufacturers Association) and the FDA," said Genentech CEO KirkRaab in a prepared statement.Recent developments surrounding these and otheractions include:u Wyden on Monday requested that the Federal Trade Commission(FTC) inquire into whether a non-profit, charitable entity, the HumanGrowth Foundation (HGF), was being used improperly by Genentechor rival human growth hormone maker Eli Lilly & Co. to promote salesof the drug. Genentech and Lilly both make corporate contributions toHGF, which conducts screening programs in schools to identify shortchildren who might need growth hormone treatment.Wyden charges that HGF "may have become part of veiled marketingand patient recruitment efforts" by Genentech and Lilly. The FTC isresponsible for protecting consumers from false or deceptiveadvertising, marketing and promotion."It is evident that in many cases, parents of children not afflicted withdwarfism are being strongly encouraged to demand this drug (humangrowth hormone) from physicians so that children who are merelybelow average height may grow to average or above-average height,"Wyden wrote to the FTC. "It is apparent that the Human GrowthFoundation has played a significant, encouraging role." Jenning toldBioWorld that subcommittee staff have been in close communicationwith the FTC's Consumer Protection Bureau in recent weeks. As aresult, he believes that Wyden's letter will result in a formal FTCinquiry or investigation."We will continue to support patient advocacy groups like the HumanGrowth Foundation because they play an integral role in improving thelives of patients," said Raab.u On Aug. 4, a federal grand jury handed down a 51-count indictmentalleging that a Minneapolis doctor, a top Genentech executive andProtropin's sole U.S. distributor, Caremark Inc., participated in anillegal scheme involving $1.1 million in kickbacks paid to the doctorby Genentech and Caremark. (See BioWorld Today, Aug. 8, 1994, p.1.) Edmon Jennings, Genentech's vice president of sales andmarketing, was indicted on three counts. He has denied all allegations.The indictment was the result of an ongoing nationwide investigationof Medicare and Medicaid fraud conducted by The Department ofHealth and Human Services' Inspector General in collaboration withthe Federal Bureau of Investigation and the Department of Justice.Sources said the investigation could yield more indictments.u On Aug. 5, the Foundation on Economic Trends, Jeremy Rifkin'sconsumer watchdog group, filed a formal petition with the DrugEnforcement Agency (DEA) to schedule human growth hormone as acontrolled substance (schedule III drug). Schedule III drugs are subjectto strict regulation due to the fact they are considered "highlyabusable," DEA deputy chief counsel Bob Richardson told BioWorld.Richardson said the DEA will review the petition to decide whether ornot to hold a hearing on the petition. Petitions can be rejected if theyare deemed "blatantly frivolous" or if they have already beenconsidered and no new information is presented in the petition."This drug is out of control and the FDA can't control its use with thesystem currently in place," Rifkin told BioWorld. "The FDA will not,cannot and has not shown any inclination to regulate this drugproperly. This is the first glamour product of biotech and the WhiteHouse and the FDA have every intention of looking away. The DEA iswhere it belongs."Genentech has argued that it has voluntarily imposed controls on itsdistribution of Protropin that eliminate the vast majority of abuse. Inaddition, federal and state laws with "very strict criminal penalties"prohibit distribution of the drug for non-medical uses, such as athleticenhancement, according to Genentech. n
-- Lisa Piercey Washington Editor
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