Wednesday, October 17, 2012

Compounding pharmacies need FDA oversight

Will Congress step in, to help the FDA?

Compounding pharmacies need FDA oversight - The Washington Post:

. . . Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation. . .

"The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time."

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Tuesday, October 16, 2012

FDA Statement on NECC Fungal Meningitis Outbreak: Additional Patient Notification Advised

Fda
Fda (Photo credit: Wikipedia)

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised:

"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), "

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Monday, October 15, 2012

Ensuring high-quality dietary supplements with 'quality-by-design' - QbD

The U.S. Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, rather than drugs.

Ensuring high-quality dietary supplements with 'quality-by-design':

"They concluded that a QbD approach — ensuring the quality of a product from its very inception — is the best strategy. One key step in applying QbD to dietary supplements, for instance, would involve verifying the identities of the raw materials — the plants — used to make supplements. “It is clear that only a systematic designed approach can provide the required solution for complete botanical characterization, authentication and safety evaluation,” they say."

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Sunday, October 14, 2012

Drugs May Last Past The Expiration Date

What Expiration? Your Drugs May Last A Long Time // Pharmalot:

"Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.

To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine"

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For more information (link to the original Arch Intern Med article):
Stability of Active Ingredients in Long-Expired Prescription Medications

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Top counterfeit drug events in 2012

The article provides links to the related drug event stories.

Top counterfeit drug events in 2012 - FiercePharma:

"This report points to some of the most significant events in the effort to address counterfeiting this year. Maybe you know of others not mentioned. It would be great if the report could start a public discussion of which steps need to be emphasized next. There is little question that more needs to be done, and it is best if it is done with some forethought. -- Eric Palmer"

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Friday, October 12, 2012

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens, 'Bloomberg Markets' Finds:

"The U.S. federal government has been fighting foodborne illness for a century, ever since Upton Sinclair terrified the country with The Jungle, his expose of the Chicago meatpacking industry. Many think these measures have been successful. House Republicans, for example, recently voted to cut the FDA's budget for food safety, using the argument that our food system is "99 percent safe."

Widely-touted statistics about the prevalence of food poisoning cast some serious aspersions on that idea. In 2011, 48.7 million Americans contracted a foodborne illness. Of those, 127,839 were hospitalized and 3,037 died."

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Wednesday, October 10, 2012

FDA seeks to reargue cigarette-warning label rules

My gut sense is that the proposed cigarette-warning labels would be effective. When I look at them, they make me feel uneasy.

FDA seeks to reargue cigarette-warning label rules:

"The agency in a filing today in the U.S Court of Appeals in Washington said the court's 2-1 ruling finding the regulations violated the free speech rights of tobacco companies under the First Amendment of the U.S. Constitution was wrong and conflicts with a ruling by a federal appeals court in Cincinnati.
The majority on the three-judge panel said in August that the government failed to present any data showing the warnings would cut smoking rates.

"The First Amendment does not require statistical proof of the extent to which the decline in smoking rates resulted 'directly' from the new health warnings," the FDA said in today's filing."

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Friday, October 5, 2012

FDA Shuts Down Thousands Of Illegal Internet Pharmacies

FDA Shuts Down Thousands Of Illegal Internet Pharmacies:

"The U.S. Food and Drug Administration has taken charge of a dangerous upturn in illegal online pharmacies that sell dangerous, unapproved medications to consumers.

In collaboration with international regulatory and law enforcement agencies, the FDA took legal action against more than 4,100 internet pharmacies via criminal charges, seizure of illegal products, and removal of websites.

This noteworthy bulletin comes directly in the midst of the 5th annual International Week of Action (IIWA), a joint venture to tackle the online sale and distribution of phony and illegal drugs."

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FDA unveils new device that detects counterfeit drugs

This CNN article has a great close-up photo of the device.

FDA unveils new device that detects counterfeit drugs – The Chart - CNN.com Blogs:

"CD3 is currently being used in 50 FDA field laboratories, as well as border crossings and import centers. It's also used in a number of international mail facilities including those in San Francisco, Los Angeles and Chicago and other points of entry, where inspectors screen drug ingredients, finished products and dietary supplements to identify counterfeit, falsified and unapproved drugs, cosmetics, foods, medical devices and cigarettes.

The battery-operated LED machine emits 10 different wavelengths of light like ultraviolet and infrared imaging and can be used on tablets and capsules, powders, and packaging (inks, papers and covert markings). It can also detect products that have been tampered with, re-labeled or re-glued. The CD3 has been used to analyze nearly 100 counterfeit products including drugs like Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singulair, Plavix and Wellbutrin."

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Wednesday, October 3, 2012

Sequestration: What Does it Mean for Pharma?

Sequestration: What Does it Mean for Pharma?:

"Overview
So let’s step back and take a look at all of this for a moment. Unless Congress gets it act together “H.R. 5872: The Sequestration Transparency Act of 2012” will go into effect on January 2, 2013. The impact of $110 billion being cut from the federal budget could no doubt lead to major losses in public and private employment, and a likely reduction of industrial capacity in many areas of the economy. All dire, and all very serious, especially at this time. But from the standpoint of the Rx industry, think about a few of the variables floating around this issue, too."

... would suggest it definitely could be tough sledding for the Rx business if the Sequester comes on line. For every employee of the Rx industry, it bears careful study.

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