Enbrel Sales Investigated
The New Jersey Attorney General's office is investigating Amgen for allegedly promoting Enbrel for off-label uses and for violating privacy laws to get access to potential new patients. On Jan. 14, Attorney General Anne Milgram subpoenaed Amgen for all documents relating to the marketing, sale, and prescription of Enbrel (etanercept) since July 2002. The inquiry follows a lawsuit by two former sales representatives who alleged that the company encouraged them to search physicians' records for patients with mild psoriasis who might be potential candidates for Enbrel therapy. The former employees also claimed to have directly contacted insurers to facilitate reimbursement to physicians for the cost of the biologic. An Amgen spokeswoman said that the company will cooperate fully with the investigation and that the employees' claims "are completely without merit." The company expects salespeople to follow the Code of Conduct. "Amgen does not instruct sales representatives to proactively review patient files or promote off-label for any reason," said the spokeswoman.
HHS Resists Ketek Subpoena
The Department of Health and Human Services has refused to comply with a House Energy and Commerce Committee subpoena of documents related to the March 2007 testimony by Food and Drug Administration Commissioner Andrew von Eschenbach on the approval of Ketek (telithromycin). "There appears to be a continued effort to keep secret the documents we have requested," said Rep. Bart Stupak (D-Mich.), chairman of the committee's oversight and investigation subcommittee. Rep. Stupak spoke at a February subcommittee hearing looking into a Ketek safety study by manufacturer Sanofi-Aventis U.S. LLC and a subsequent FDA inquiry into fraud allegations surrounding that trial. Subcommittee members heard testimony from Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and from FDA and independent investigators that agency officials and Sanofi-Aventis executives ignored warnings that the safety study was riddled with fraud. Both the House panel and the Senate Finance Committee want to determine what the FDA and Sanofi-Aventis knew about the alleged fraud and when. Energy and Commerce Chairman John Dingell (D-Mich.) said he would compel HHS to furnish the documents. An FDA spokeswoman said the agency has given the committee "more than 80,000 pages of information on Ketek," and that the agency has "made every effort to be responsive to the committee's requests."
Reloxin Approval Delayed
FDA has refused to accept the biologics license application filed by Medicis Pharmaceutical Corp. for Reloxin (injectable botulinum toxin type A), according to a Securities and Exchange Commission filing by the company. According to the filing, the application was deemed incomplete because it did not "address how Medicis would fulfill its responsibilities as the manufacturer of the product." The company said the agency cited only administrative, not substantive, problems with the application for approval. Medicis, which licensed Reloxin from the Ipsen Group for commercialization in the United States, Canada, and Japan, "intends to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues," according to the filing.
Eyelash Lengthener Sales Halted
Jan Marini Skin Research Inc. has stopped selling its Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes Performance Mascara in the United States. The company cited its involvement in ongoing patent litigation with Allergan Inc. as one reason for ceasing sales. In a statement, CEO Jan Marini said the company had confidence in the products' safety profile. An older, discontinued product, Age Intervention Eyelash, was the subject of an FDA seizure last November. The agency seized $2 million worth of Age Intervention Eyelash, saying that it was misbranded because it contained bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure. However, Jan Marini had discontinued making or selling Age Intervention Eyelash in 2006. Allergan markets bimatoprost under the trade name Lumigan.
More Action Needed on MRSA
U.S. health care facilities are not doing enough to protect patients from methicillin-resistant Staphylococcus aureus (MRSA) infections, according to an online poll conducted by the Association for Professionals in Infection Control. A majority of infection control professionals (59%) responded that their health care facilities have stepped up efforts to curb MRSA in the past 6 months. But half said their facilities were "not doing as much as [they] could or should" to stop the transmission of MRSA. "MRSA could be beaten if the leadership at hospitals moved more aggressively to adopt strategies proven to protect patients from these virulent infections," said Lisa McGiffert, director of Consumers Union's Stop Hospital Infections campaign. "We need to require hospitals to report their infection rates so the public can see if they are achieving results." Consumers Union has worked to help pass laws in 20 states requiring hospitals to report their patient infection rates, and it supports a federal infection reporting law. The Centers for Disease Control and Prevention estimates that nearly 95,000 patients developed MRSA infections in 2005—most of which were acquired in health care facilities—and almost 19,000 people died.