Ranbaxy’s New Year’s Resolution

Erik Greb PharmTech editorRight now, many of us are thinking of how we could improve ourselves during the new year. Others, such as Ranbaxy, will be forced to improve themselves in 2012. The company signed a consent decree last week, and its management must be eager to put its ugly past behind it. Read more »

Taking Drugs off the Short List

Erik Greb PharmTech editorDrug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Is HHS Using Scientific Standards?

Erik Greb PharmTech editorJust when it seemed that controversy over the Plan B contraceptive was a thing of the past, the drug returned to the headlines. In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius overruled FDA’s decision to allow Teva’s Plan B One-Step to be sold over the counter to girls under the age of 17. In a public statement, Sebelius said that about 10% of girls can bear children by 11.1 years of age. Teva’s “label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” she said. But FDA sees the matter differently. Read more »

Let’s Fight Adulteration with Information

Erik Greb PharmTech editorEconomically motivated adulteration became a major concern after heparin manufactured by Baxter Healthcare was contaminated with oversulfated chondroitin sulfate. FDA told the Government Accountability Office (GAO) that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Companies have been reluctant to share this information, but a GAO report suggests a possible solution. Read more »

Could Ben Venue’s Manufacturing Suspension Have Been Avoided?

Erik Greb PharmTech editorWhen only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »

Accelerated Approvals Could Raise Risks for Patients

Erik Greb PharmTech editorFDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

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Prosperity through Biology

Erik Greb PharmTech editor

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

A Pharma Microcosm for Manufacturing

Patricia Van Arnum PharmTech editor AstraZeneca’s announcement this week that it is investing $200 million in a new manufacturing site in China, the largest investment by the company in a single manufacturing facility, reflects not only the ongoing trend on pharmaceutical industry investment in emerging markets, but also speaks to the larger issue of ways to stimulate manufacturing investment in the United States. As President Barack Obama looks for support for his jobs bill from Congress and the public, a basic question is whether federal policy is on the right track to stimulate business investment in the US. Read more »

Better Quality Could Mean Fewer Drug Shortages

Erik Greb PharmTech editor

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Could Wild Gudgeon Be Canaries in a Coal Mine?

Erik Greb PharmTech editor

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

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