GAO reports that FDA still lags in DTC violation warnings
WASHINGTON The Government Accountability Office has released a report stating that the Food and Drug Administration continues to lag in sending warnings or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer advertising rules.
Marcia Crosse, the head of the GAO’s health care division told a House Oversight and Investigations Subcommittee last week that the FDA last year took an average of six months to issue regulatory letter citing “violative” DTC materials. Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review it took less than a month to send such letters according to Crosse.
The FDA has not improved since a 2006 GAO report found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter,” according to the GAO report accompanying Crosse’s testimony. “In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”
Moreover, only two regulatory letters on DTC advertising went out in 2007—one warning letter and one untitled letter—compared with 15 to 25 regulatory letters each year between 1997 and 2001, before the legal review policy. Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” the GAO report said—approximately 6,000 in 1999 as compared with 21,000 in 2007.
AmerisourceBergen reorganizes management
VALLEY FORGE, Pa. Drug distribution and health services giant AmerisourceBergen Corp. today announced a major restructuring of its operations.
The result, said company spokesman Michael Kilpatric, will be a “more streamlined organizational structure designed to drive increased efficiency and effectiveness.”
In line with the changes, Terry Haas, ABC executive vice president and chief integration officer, has left the company “to pursue other interests,” according to the company. ABC president and chief executive officer R. David Yost praised Haas for his “extraordinary contribution to AmerisourceBergen,” as well as the major role he played in the integration of Amerisource and Bergen Brunswig following their merger.
Yost explained the restructuring as follows: “To continue meeting the challenges of an ever changing pharmaceutical environment, AmerisourceBergen needs the infrastructure and cost structure that allows the Company to compete as the most efficient and effective operating company in our industry. It is with that singular focus that we are further integrating our organization.”
The organizational changes are effective immediately. Among the management shifts underway:
- Michael DiCandilo, ABC executive vice president and chief financial officer, expands his duties with the added position of chief operating officer for AmerisourceBergen Drug Corp. (ABDC) and continues to report directly to Yost. The ABDC functions reporting to DiCandilo in his new role include Supply Chain Management; Operations—including the distribution network—and Financial Operations, which previously reported to him. Yost continues to lead ABDC and continues to have the executives leading sales and marketing reporting to him.
- Steven Collis, executive vice president of AmerisourceBergen and president of the ABC Specialty Group, also has an expanded role that now encompasses supervision of PMSI, the company’s workers’ compensation business. “Steve continues his responsibilities for helping shape the policy and strategy of ABC and for more closely integrating [the specialty group] across AmerisourceBergen,” the company noted. He continues to report directly to Yost.
- Thomas Murphy, senior vice president and chief information officer, will also take on additional duties by assuming leadership of Business Transformation, the company’s multi-year process improvement project, which includes design of an ERP (Enterprise Resource Planning) system for ABDC and the corporation. Yost continues his executive leadership of the overall improvement effort, while Murphy continues to report directly to DiCandilo.
FDA sees growing number of counterfeit drugs
NEW YORK According to The Lancet, the Food and Drug Administration saw an eight-fold increase in the number of new counterfeit prescription medications from 2000 until 2006.
What’s worse is that worldwide sales of counterfeit drugs are forecasted to reach $75 billion by 2010. This is, in part, due to weak regulatory systems in developing countries, where around 10 to 30 percent of drugs might be fake, according to the journal.
Counterfeiting may have caused the deaths of at least 81 patients in the U.S. after they were treated with a contaminated batch of heparin, a blood-thinning drug.
Last week the FDA told a congressional hearing it believed a dangerous contaminant found in batches of the heparin may have been deliberately added. The contaminant, traced back to a Chinese supplier, was structurally similar to heparin but 100 times cheaper.
The counterfeit drug trade was becoming more difficult to combat even before the tainted heparin was discovered, as criminals were using more sophisticated techniques to bypass standard laboratory tests. For instance, by adding cheaper substances that mimicked genuine drugs.
Substances used to taint medicines varied from chalk to antibiotics to highly lethal substances, said the editorial.