USP Faces New Challenges

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting with stakeholders, reviewing the organization’s operations, and examining options for growth and change as part of the agenda for the next USP convention in April 2015.

Piervincenzi comes to USP with training in bioengineering and expertise in management gained at McKinsey & Co., where he worked on multiple projects involving regulatory and medical affairs for many parties involved in USP activities, including manufacturers of drugs, dietary supplements, veterinary medicine, and foods. As the biomedical world has

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FDA Wants You!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and CDER leaders are looking for experienced industry managers to help rebuild its staff.

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Many experienced FDA staffers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment of the agency,” explains Richard Moscicki, deputy director for science operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013 and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

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A New Strategy to Tackle Antibiotic Resistance

VLUU L110  / Samsung L110We all know that the discovery of penicillin by Alexander Fleming was a turning point in medical history, which led to the development of lifesaving antibiotics. But who would have thought that decades down the road, we would be battling antibiotic resistance on a global scale. Data from the European Centre for Disease Prevention and Control (ECDC), released at the end of last year, showed a marked increase in carbapenem-resistant infections across Europe. Mortality rates have increased as well due to the limited options of antibiotics available to treat these infections. According to the European Commission, the widespread prevalence of antibiotic resistance has been estimated to cause approximately 25,000 deaths annually and more than €1.5 billion in healthcare expenses and productivity losses in Europe alone. A June 2013 report by IMS Health, “Avoidable Costs in US Healthcare,” noted that in 2012, there were 900,000 hospital admissions for drug-resistant conditions. According to IMS Health, the avoidable cost from antibiotic misuse ranges between $27 billion to $42 billion. Read more »

Drug-Diagnostic Development Stymied by Payer Concerns

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Obama Administration Halts Attack on Medicare Drug Plans

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. The Centers for Medicare and Medicaid Services (CMS) had issued a proposed rule Jan. 10, 2014 to drop “protected” class status for antidepressants and immunosuppressants in 2015 and antipsychotics in 2016, and to limit the number of Part D plans an insurer can offer in each Medicare region. Insurers and pharmacy benefit managers (PBMs) backed the reduction in protected drug classes as a way to gain leverage in negotiating lower prices from manufacturers.

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Obama Budget Takes a Slap at Pharma

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Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks from drug counterfeiting activities, noted Marcia Crosse, director

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