Pharmaceutical Commerce - March/April 2012 - (Page 1)

MARCH/APRIL 2012 Brand Marketing & Communications Legal & Regulatory Adding rigor to the adverse event reporting process As FDA makes progress on an active surveillance system, drug manufacturers and third-party drug safety vendors navigate their own set of challenges By Lena Anthony Manufacturers are reviving their serialization plans The pioneering firms that installed serialization and track-and-trace systems are being joined by a fast follower crowd, but an industry-wide commitment is still in the future By Nicholas Basta The widely accepted statistic is that only about 10% of all adverse events (AEs) are reported to FDA. In 2010, that 10% equaled about 750,000 reports, which was an almost 31% increase over 2009 and the biggest year-over-year increase (as a percentage) in the last decade. The estimates for 2011 aren’t due for another couple of months (per FDA), but they’re expected to continue the upward trend. Pharmacovigilance experts agree that one of the main drivers of recent growth in AE reporting rates is, quite simply, increased awareness of drug safety and adverse event reporting among pharma companies, as well as healthcare providers and consumers. But new developments in pharmacovigilance will likely drive those rates higher, while others will help pharma companies manage the increasing volume. Besides the long-standing FDA requirement for post-marketing monitoring of the adverse events associated with a drug, and acknowledging the greater emphasis that FDA is putting on all aspects of drug safety these days, manufacturers have an additional reason to pay close attention to AE reporting: A year ago, the Supreme Court ruled unanimously that even a number of AEs not “statistically significant” might need to be reported to stockholders of the company as a “material” financial event. The case, Matrixx Initiatives, Inc. vs. Siracusano (Case 09-1156) was brought by investors after a Matrixx product, an OTC cold remedy called Zicam, was found to have side effects that ultimately led to the product’s recall. Trends in outsourcing As the volume of AERs increases, the number of resources needed to process and analyze them rises as well. Instead of handling pharmacovigilance activities in-house, many pharma companies outsource the process, either wholesale, as in the case of small manufacturers, or as partners (see Pharmaceutical Commerce, Jan/ Feb 2011, p. 1). Some companies in the outsourced AER business are reporting double- and even triple-digit growth: Elizabeth Garrard, chief safety officer of Drug Safety Alliance (Research Triangle Park, NC) estimates her continued on page 18 Veterans of the pharma serialization wars of the past eight years are starting to smile again: business activity is picking up in companies announcing projects, releasing RFPs and renewing debates over how best to proceed. After California postponed its serialization track-and-trace mandate in 2008 (pushing it off to 2015 at the earliest, and practically pleading for the feds to step in), the rising tide of project work hit a wall, and things haven’t been the same since. Activity did not come to a dead stop; and in the meantime, similar efforts in the European Union, and pharmaconcentrated countries like India, Brazil and China had taken some steps themselves. The GS1 organization has steadily moved forward with planning workshops, implementation guides and standards development. Companies that were bidding for serialization business pre-2008 have been dusting off and updating their technical specifications; and new players are entering the fray. “There have been some lean years for a lot of us since 2008,” says Greg Cathcart, president of Excellis Health Care (New Hope, PA; www., an IT consulting firm focused on life sciences supply chain. “Now there are some fast-moving companies preparing for the national and international mandates, and we’re already seeing a continued on page 32 Manufacturing & Packaging Temperature-sensing options multiply for cold-chain shipments Dataloggers, chemical and electronic indicators, and ‘hybrid’ devices are now available to meet growing industry requirements By F.J. Quinn The number of pharmaceutical companies utilizing temperature monitoring devices for refrigerated drug shipments continues to climb, a reflection of heightened industry and global regulatory concern over maintaining safe transportation conditions. As a result, vendors of coldchain sensors, packaging, and transportation services are expanding the range of technologies and capabilities they offer to manage these deliveries. By 2016, eight of the top 10 pharma products are projected to require constant temperature monitoring, according to an industry study. In most cases, cold-chain products are shipped in an insulated container which uses ice, gel packs and other materials that help maintain the required temperature. In addition to shipping containers, cold-chain management requires a wide range of other factors drug makers must take into consideration, such as distribution carriers to be contracted, refrigeration or humidity control equipment (if required), environmental conditions at each location along the supply chain, and length and time of the distribution route. continued on page 29 March | April 2012 1 MENDOTA, IL PERMIT 232 PRSRT STD US POSTAGE PAID

Table of Contents for the Digital Edition of Pharmaceutical Commerce - March/April 2012

Pharmaceutical Commerce - March/April 2012
Top News
Brand Marketing & Communications
Supply Chain/Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatory
Executive Development
Meetings and Editorial Index

Pharmaceutical Commerce - March/April 2012