Indian Hospira Plant Gets Form 483 With 23 Observations

December 27, 2013

The FDA has hit Hospira with a new Form 483 containing 23 observations after a return visit to its Irungattukottai, India, plant. Read More

December 28, 2013 Area attorney applauds fund for meningitis victims BY ANNE STANTON astanton@record-eagle.com

TRAVERSE CITY — A Traverse City attorney who represents dozens of clients who have suffered or died from tainted steroid injections welcomed the announcement of a $100 million-plus fund to compensate victims.

“I am encouraged by how quickly this came out,” said Traverse City attorney Mark Dancer.

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Must Read! Trends in FDA cGMP Violations: Department of Justice announced that compliance with current good manufacturing practices (cGMPs) will be one of the agency's "top areas of focus

We have previously written that one of the new trends in enforcement in the life sciences industry is the focus the federal government is having on compliance with current good manufacturing practices (cGMP).

For instance, we noted back in February of this year that the U.S. Department of Justice announced that compliance with current good manufacturing practices (cGMPs) will be one of the agency's "top areas of focus" in the coming year." Additionally, we recently noted that DOJ has been probing international pharmaceutical manufacturing, investigating several companies and their manufacturing practices over the last several months.

Most recently, DOJ filed a lawsuit on behalf of the FDA against Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger, as reported by FiercePharmaManufacturing. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops, including a lacking of procedures to protect against microbiological contamination. Among other issues, a 2011 FDA warning letter said the company had released several batches of sterile ophthalmic eye drops without adequately validating aseptic processes, and wasn't testing the water used to make the drops.

- See more at: http://www.policymed.com/2013/12/trends-in-fda-cgmp-violations.html#sthash.denFL6W0.dpuf

The Discrediting OTC Ads – Articles Include Potentially Misleading Claims

A recent study published in the Journal of General Internal Medicine found that as many as "six out of 10 pharmaceutical ads" contain "potentially misleading claims." The objective of the study was to compare claims in direct-to-consumer (DTC) television advertising with the FDA approved labeling in order to evaluate the frequency of false or misleading ads.

The United States is one of the only countries in the world that allows drug companies to directly advertised to patients or consumers through basically any medium—television, magazine, newspaper, etc. However, we recently reported that advertisements online and through social media have been a difficult and uncertain area for companies to advertise due to the lack of guidance and clarity from FDA on the issue.

To conduct the study, the authors analyzed a cross-section of TV ads for prescription and nonprescription drugs aired from 2008 through 2010 on ABC, CBS, NBC and CNN broadcasts. The researchers looked only at ads between 6:30 and 7:00 pm EST.

It should be noted that advertisements of any kind for nonprescription drugs (e.g., over-the-counter) are regulated by the Federal Trade Commission (FTC) not the FDA—however, FDA and FTC have a close working agreement to determine whether a nonprescription drug ad may be making an improper claim.

- See more at: http://www.policymed.com/#sthash.xMIQLeoH.dpuf