Issue link: https://viewer.e-digitaledition.com/i/1000808
Drug Approved for HIV Patients with Few Treatment Options BY STEVE BARRETT THE FDA HA S APPROVED TROGARZO, A MEDICATION FOR ADULTS WITH HIV WHOSE INFECTION CANNOT OTHERWISE BE TRE ATED EFFECTIVELY. "WHILE MOST PATIENTS living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death," Je‡ Murray, MD, Deputy Director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, stated in a news release. "Trogarzo ... can provide signifi cant benefi t to patients who have run out of HIV treatment options." In a clinical trial, many of the 40 participants — all of whom had multidrug-resistant HIV — had been treated with at least 10 anti- retrovirals previously. Most saw a signifi cant drop in their HIV-RNA levels a week after researchers added the new drug to their regimens. Forty-three percent experienced HIV-RNA suppression after using Trogarzo and other antiretroviral drugs for 24 weeks, the FDA reports. A healthcare provider administers the medi- cation once every two weeks, in combination with other antiretrovirals. Approximately 40,000 Americans were diagnosed with HIV in 2016, according to the CDC. ■ CORE LESS FAMILIARIT Y BE T WEEN FDA INVESTIGATORS AND MANAGEMENT AT MEDICAL DE VICE MANUFACTURING PL ANTS MAY ME AN FE WER RECALLS DOWN THE ROAD, RESE ARCH IN THE JOURNAL MANUFACTURING & SERVICE OPERATIONS MANAGEMENT SUGGESTS. T HE AU T HOR S L O OK ED at outcomes of nearly 4,800 FDA plant inspections as well as almost 2,900 recalls linked to more than 2,200 plants. The second time the same investigator inspected a plant, the risk of a future recall grew by 21 percent. The risk rose by 57 percent after the investigator's third inspection of the same plant, according to the authors, who are from Indiana University, the University of Minnesota and the University of Wisconsin-Madison. "These increased recall risks may be symptomatic of increased familiarity between plant management and a repeat investigator, enabling the plant to relax its standards," Enno Siemsen, Executive Director of the Erdman Center for Operations & Technology Management at the University of Wisconsin-Madison, stated in a news release about the research. Putting investigators on a rotating schedule with regard to the plants they inspect could yield an estimated annual reduction of 100 medical device recalls, the authors concluded. "Our fi ndings demonstrate that the FDA and likely other federal regulators must navigate a fi ne line in their relationships with industry managers," said Rachna Shah, Associate Professor in the Supply Chain and Operations Department at the University of Minnesota's Carlson School of Management. ■ May Reduce Recalls BY STEVE BARRETT Rotating Inspectors at Medical Device Plants M D N E W S . C O M /// M D N E W S L O W E R H U D S O N / B R O N X ■ 2 018 I N N O V A T I O N ¡T E C H N O L O G Y ❰❰❰❰❰ 0 5