The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration. Read more »
At a joint session of the PharmTech Conference and the 4th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight. The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »
The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »
A new report released by OpSec Security, a provider of anticounterfeiting and brand protection services, found an increased amount of illicit behavior in sales of bulk pharmaceuticals and prescription drugs over the Internet. Read more »
One of the International Criminal Police Organization’s (Interpol) six priority crime research areas is drugs and criminal organizations. As reported in the New York Times on July 20, the organization is working with an informal group of researchers and government officials in Africa, Asia, and the US to track counterfeit drugs that claim to treat malaria, a disease that takes nearly 1 million lives a year. Read more »
“Geopolitical environmental scanning” seems to be the new catch phrase in supply chain security. The term came up multiple times during the ISPE conference and during the launch meeting of the Rx-360 consortium, both of which took place in Washington, DC, the first week of June.
IPEC–Americas Chair Janeen Skutnik mentioned geopolitical environmental scanning as a way to detect, in advance, potential weaknesses in or disruptions to the supply chain that could lead to contamination, adulteration, or counterfeiting. Read more »
The buzz around Rx-360, an international pharmaceutical supply chain consortium headed by seven advisory panel members including Martin Van Trieste of Amgen, has been brewing for months. More than 125 people attended the consortium’s launch meeting in Washington, DC, last Friday, June 5—quite a few more than Van Trieste and his team originally expected. Clearly, the turnout demonstrated industry’s interest in working together to help improve supply chain security. Also demonstrating a yearning for cohesion were the results of the meeting’s live polling questions. Using devices to vote from their seats, 100% of meeting participants agreed that Rx-360 was needed. Most also said they would join or are considering joining the consortium. Read more »
Yesterday, Thomas Lavery, 63, of Irvine, California, was sentenced to four years and four months of incarceration to be followed by three years of supervised release by the US District Court in Concord, New Hampshire, for his involvement in a prescription drug diversion case, according to a court release. Read more »
Newly appointed US Food and Drug Administration Commissioner Margaret Hamburg and FDA Principal Deputy Commissioner Joshua Sharfstein provided a broad vision for FDA in a recent New England Journal of Medicine article by asserting that the primary role of FDA should be as a public health agency and stressed the value of building collaborative models with other federal agencies, industry, and other national regulatory bodies in serving that function. Read more »
The winners of this year’s RFID Journal Awards were announced at the annual RFID Journal LIVE! conference and exhibition earlier this week. The winner for Best in Show was ODIN Technologies for its self-inventorying SMART Container, a system that monitors items within a shipping container and then transmits that information to any ERP system via satellite, cellular and active RFID. Read more »
From PharmTech.com