Arrests Made in Sale of Counterfeit Diet Pills

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Posted on 30th March 2010 by gjohnson in Uncategorized

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Contaminated heparin imported from China still unknown numbers of people in the United States since 2007. Now counterfeit diet pills from China, which have ingredients that can prompt heart attacks, are hitting the American market. http://online.wsj.com/article/SB10001424052748704094104575144560727634680.html?KEYWORDS=Alli

The U.S. Justice Department has arrested Sengyang Shou, a Chinese national, and Qing Min Hu, a U.S. citizen born in China. The pair are accused of illegally importing diet products, including a knockoff of GlaxoSmithKline’s Alli, that they told buyers were less pricey versions of government-approved medications, according to The Journal.

The counterfeit drugs were being sold on Web sites that claimed they were legal, but less expensive, versions of the diet pills. But when one man took the pills, he started getting chills, headaches and symptoms like those of a heart attack.

The Food and Drug Administration has warned consumers about buying weight-loss products via the Internet. The FDA has tested diet products sold on the Web and discovered they contained sibutramine, an ingredient that is used in some weight-loss pills, but not Alli.

Sibutramine has been barred in some countries and there have been calls for its use to be banned in the United States.

The latest case is being handled not only by the Justice Department but also the \FDA’s Office of Criminal Investigations, the U.S. Postal Inspection Service and U.S. Immigration and Customs Enforcement/

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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Heparin Rival Is In A Pickle Over Patent For Angiomax

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Posted on 19th March 2010 by gjohnson in Uncategorized

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The manufacturer of a rival blood-thinner to the generic heparin is trying to overcome what The New York Times Friday called “one of the costliest blunders in drug industry history.” http://www.nytimes.com/2010/03/19/business/19patent.html

The Times story, headlined “A Company Races to Keep a Drug Patent,” describes the predicament of Parsippany, N.J.-based Medicines Co., which makes the blood thinner Angiomax.

In a clerical error that should have cost someone his or her job, Medicines back in 2001 missed a deadline to apply for a patient extension for Angiomax. So now that patent is set to expire next Tuesday, instead of in December 2014. That means generic versions of the drug will be able to come to market.

The drug maker has filed several appeals with patent officials over its goof, unsuccessfully. But Tuesday a federal judge ruled that the U.S. Patent and Trademark Office must reconsider its denial of Medicines’ 2001 filing.

The Times’ story outlines all of Medicines’ machinations to retain its patent on Angiomax. And that includes a convoluted argument by Medicines’ about its blood thinner versus heparin.

The drug makers has studies that maintain that it would save the health care system billions of dollars over the next two decades if Angiomax retains its patent.

Medicines argues that a continued patent would mean more promotion for Angiomax, and possibly new uses for it, according to The Times. So its use would increase at the expense of its main competitor, generic heparin.

Yet Angiomax is much pricier than heparin, at more than $600 a patient, versus pennies for heparin.

“But Medicines argues that Angiomax is actually cheaper for the health care system overall than heparin, partly because it causes less bleeding, a serious and costly side effect,” The Times writes.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Baxter Having Issues Passing New Heparin-Potency Test

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Posted on 15th March 2010 by gjohnson in Uncategorized

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Baxter International, the maker of the blood thinner heparin, says it’s encountering problems having its drug pass a stricter drug-potency test, according to the magazine Modern Healthcare. http://www.modernhealthcare.com/article/20100315/NEWS/303159895

The update that has Baxter troubled has been devised by U.S. Pharmacopeia (USP), and provides potency reading for heparin that are 10 percent greater than the old test.

“It’s taking us a bit longer than anticipated to meet the requirements of the new test,” Baxter spokeswoman Kellie Hotz told Modern Healthcare.

She added that Baxter has been talking to the Food and Drug Administration about way it can meet the new USP standard.

The heparin that is currently being testing is pre-mixed product, not the concentrated vial product that was investigated by the FDA last year, Hotz told Modern Healthcare.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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FDA Soon To Issue Guides On Tracking/Tracing Drugs

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Posted on 13th March 2010 by gjohnson in Uncategorized

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It may have taken three years since the heparin-contamination tragedy, but the Food and Drug Administration is apparently close to issuing its guidance for the tracking and tracing of medicines. http://www.securingpharma.com/40/articles/403.php

Joshua Sharfstein, FDA deputy commissioner, said Thursday that the guidance will set “a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits.”

He made his remarks before a House Energy and Commerce health subcommittee meeting, which was called “Drug Safety: An Update From The FDA.”

Coming up with a better system of tracking drugs is crucial, especially when about 80 percent of all active pharmaceutical ingredients used by U.S. drug makers come from overseas, according to a 1998 U.S. General Accounting Office study.

During his testimony, Sharfstein claimed that the FDA has made great progress beefing up the oversight of foreign-made drug ingredients that are coming into the United States, For example, it has opened offices in several countries and now has information-sharing deals with foreign regulatory agencies.

Sharfstein also cited the calamity involving Chinese-made heparin, which he said caused the deaths at least 80 Americans, during his comments to the subcommittee.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Group Produces Guide Aimed To Prevent Incidents Like The Heparin Contamination Tragedy

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Posted on 3rd March 2010 by gjohnson in Uncategorized

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It’s too bad this wasn’t around in 2008, when Americans were dying after getting tainted heparin from China: a guide that helps drug makers and their suppliers identify risk in the supply chain.
http://www.securingpharma.com/40/articles/395.php

The Pharmaceutical Quality Group (PQG) has put together the guide, which says that globalization and cost-consciousness has made the pharmaceutical supply chain very complex. And that can “reduce both the knowledge and understanding of the exposure to risk.”

The story on the guide notes that it is being published “in the wake of serious incidents in which the integrity of the pharmaceutical supply chain has been compromised to allow substandard and adulterated ingredients to find their way into medicines.”

The example cited: the contamination of the blood thinner heparin made in China in 2007 and 2008, which lead to the deaths of more than 200 people around the world.

The “how-to” guide goes into detail about techniques for managing supply chain risk, and illustrates how these can be applied in the pharma industry, including in instances like the heparin incident.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney