FDA Enters Consent Decree Against FL Drug Companies
The U.S. Food and Drug Administration announced today that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc., and Hill Labs, Inc. (collectively referred to as “Hill”), and individuals Jerry S. Roth and Rosario G. Ramirez, from introducing adulterated drugs into interstate commerce. The government’s complaint […]
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US economic woes “leading to risky Rx practices”
Financial pressures are leading more Americans to take potentially dangerous actions with prescription drugs, a new survey has found. At the US Consumers Union, the Consumer Reports’ National Research Center has for the last three years conducted an annual survey asking consumers about their medication and health care use, and this year, the percentage of […]
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Sanofi’s Questionable Allergy Test
Here’s a way to generate consumer interest in your over-the-counter allergy medicine – strike a deal with a supermarket chain that agrees to offer free allergy tests. Results are mailed within three weeks and those who test positive to such common allergens as wheat, egg, cat dander, ragweed or timothy grass get a personalized “Allergy […]
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Researchers Not Making Raw Study Data Available
Medical journals may urge researchers to make raw study data available publicly, but many researchers are still not doing so, according to recent study in PLoS One, which reviewed 351 paper from 50 medical journals that have the highest impact. The review found a wide variation in policies for sharing data and how researchers follow […]
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Merck Pays $1.5M Fine For Pollution Problems
For violating several federal environmental laws at two Pennsylvania plants, Merck has agreed to pay a $1.5 million civil fine and settle charges brought by both the US Environmental Protection Agency and the US Department of Justice. Since the drugmaker has already resolved the violations, though, the feds have filed papers to dismiss their original […]
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Judge questions images for cigarette packages
A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether […]
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Drug Shortages Prompt Legislation to Help FDA Confront Problem
Medicines that are critical to fighting cancer as well as anesthetics, electrolytes for intravenous drips, and emergency drugs are facing severe shortages in the U.S. The American Hospital Association surveyed 820 hospitals this summer and found that at least half experienced shortages with more than 20 drugs, and 75 percent started rationing drugs. [1] The […]
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US generics group’s drug shortage plea
The record number of drug shortages currently ongoing in the US is a result of intensified regulatory inspections, said Paul Bisaro, chairman of the industry trade body Generic Pharmaceutical Association (GPhA) and CEO of Watson Pharmaceuticals. Speaking to the Financial Times, Bisaro said higher costs incurred by generic manufacturers due to heightened inspection efforts from […]
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Why Pharma Stocks Can Rise Before Trial Results
In a conclusion that is unlikely to surprise some investors, a new study has determined that advanced knowledge of Phase III clinical trials of new cancer meds and FDA decisions may affect the publicly traded shares prices of drugmakers. Put another way, shares in drugmakers tend to rise during the run up to reporting positive […]
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India May Cap Foreign Investment In Pharma
Will India place a cap on foreign investment in its pharmaceutical industry? The issue has been simmering ever since the Department of Industrial Policy and Promotion floated a paper more than a year ago suggesting such a move in response to an increasing number of purchases of domestic drugmakers by big pharma based overseas. A […]
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