Monday, September 24, 2012

The Makena Story


Michelle Oxman has written a blog entry entitled, What Does the Makena Story Tell Us About the Orphan Drug Act?, (September 24, 2012).  The article deals with why prescription drugs are a large portion of health care spending.  The article does a good job of explain the  Orphan Drug Act (ODA) (P.L. 97-414)  and of discussing the K-V v. FDA decision.  To read this article click here.

Saturday, September 22, 2012

Man convicted for role in international counterfeit drug distribution scheme

Man convicted for role in international counterfeit drug distribution scheme
August 9, 2012
Los Angeles, CA

Man convicted for role in international counterfeit drug distribution scheme
Search continues for organization's ringleader


LOS ANGELES — A Puerto Rican man faces up to 10 years in prison after being found guilty by a jury this week on federal charges stemming from his role as a key operative for a drug ring that distributed large quantities of Chinese-made counterfeit pharmaceuticals throughout the United States and worldwide.
Francis Ortiz Gonzalez, 36, was convicted following a six-day trial on one count of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals. His sentencing is set for Nov. 8 before U.S. District Judge George Wu. Ortiz-Gonzalez. His wife, Ideliz Aleman-Valentin, and two other defendants were named in a 30-count indictment handed down by a grand jury in Los Angeles in June 2009. The jury that convicted Ortiz acquitted Aleman-Valentin.
In 2009, special agents with U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) executed a federal search warrant at Ortiz-Gonzalez's residence in Trujillo Alto, Puerto Rico, a suburb of San Juan. Inside the home, investigators found more than 100,000 pills made to resemble a variety of popular prescription medications, including Viagra, Cialis, Valium, Xanax and Lipitor. The ensuing investigation revealed that Ortiz-Gonzalez had packaged and shipped more than 160,000 counterfeit tablets during a six-month period in 2009 while working for the organization. Many of those shipments were mailed to Southern California, which is why the case was brought to Los Angeles.
The burgeoning popularity of e-commerce has led to an explosion in the number of websites offering prescription drugs online," said Claude Arnold, special agent in charge for HSI Los Angeles. "But consumers who are considering purchasing pharmaceutical products over the Internet should heed that old expression 'buyer beware.' Part of what you're paying for when you buy established brands, regardless of the product, is quality control. Imposter drugs like these pose a serious threat to users who mistakenly assume these substances are safe."
The indictment allege that Ortiz-Gonzalez acted as U.S.-based distributor for a criminal enterprise, allegedly headed by Bo Jiang, 34, a Chinese national whose last known residence is New Zealand. In January 2011, Jiang was taken into custody on a provisional arrest warrant by authorities in New Zealand, but fled shortly after being released on bond. He remains a fugitive.
According to the indictment, Jiang advertised the counterfeit medications over the Internet. As part of the scheme, he allegedly recruited individuals from around the world to act as distributors for the products. The U.S.-based distributors, including Ortiz-Gonzalez, were responsible for receiving the parcels of counterfeit pharmaceuticals from China, then repacking and shipping them to fill individual customer's orders throughout the United States.
The probe, which commenced in 2008, involved HIS Los Angeles, the Food and Drug Administration, Office of Criminal Investigations and the U.S. Postal Inspection Service.
The Department of Homeland Security and the Department of Justice are working together to combat intellectual property crimes. In fiscal year 2011, HSI and U.S. Customs and Border Protection made nearly 25,000 seizures involving counterfeited and pirated products, a 24 percent increase compared to fiscal year 2010.
As the largest investigative arm of the Department of Homeland Security, HSI plays a leading role in targeting criminal organizations responsible for producing, smuggling and distributing counterfeit products. HSI focuses not only on keeping counterfeit products off our streets, but also on dismantling the criminal organizations behind such illicit activity.

You may also visit us on Facebook, Twitter and YouTube, or access this news release on your mobile device.
U.S. Immigration and Customs Enforcement (ICE) is the largest investigative arm of the Department of Homeland Security.
ICE is a 21st century law enforcement agency with broad responsibilities for a number of key homeland security priorities. For more information, visit www.ICE.gov. To report suspicious activity, call 1-866-347-2423 or complete our tip form.
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Balancing Immediate-Use CSPs Against Drug Shortages : September 2012 - Pharmacy Purchasing & Products Magazine

Balancing Immediate-Use CSPs Against Drug Shortages : September 2012 - Pharmacy Purchasing & Products Magazine

State Regulations Impact USP 797 Compliance : April 2012 : State of Pharmacy Compounding - Pharmacy Purchasing & Products Magazine

State Regulations Impact USP 797 Compliance : April 2012 : State of Pharmacy Compounding - Pharmacy Purchasing & Products Magazine

Friday, September 21, 2012

K-V v. Cook (Georgia)

On September 10 2012, K-V filed a Motion for Leave to File a Surreply in Opposition to Defendants' Motion to Dismiss with Brief in Support.  To view that motion click here.  On September 18, 2012  Georgia  filed a Response to Motion for Leave to File a Surreply in Opposition to Defendant's Motion to Dismiss.  to view that response click here.

Franck's Answer and Counterclaim in Insurance Litigation

On September 20, 2012, Franck's Lab, Inc., filed an Answer and Affirmative defenses to Complaint and also filed a Counterclaim against the Cincinnati Insurance Company. To view the answer click here.
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K-V v. Keck (SC)

On September 12, 2012, K-V Pharmaceutical Company, Ther-Rx Corporation filed a Supplemental Submission, which was a statement with regard to South Carolina's DHHS's Provider Manual.  To view this supplemental filing, click here.

Settlement Conference Set in K-V v. Hamos (Illinois)

09/19/201225 MINUTE entry before Honorable Susan E. Cox: Case called for status hearing. Status hearing stricken. Settlement discussion held in chambers. Settlement conference set for 10/12/12 at 9:00 a.m. Parties are to review and to comply with this Court's Standing Order Setting Settlement Conference which is available through the Court's web page. Plaintiffs' counsel to submit a written itemization of damages and settlement demand to defendants' counsel with a brief explanation of why such a settlement is appropriate on or before 9/28/12. A courtesy copy of this submission must be sent to the Court at the same time. Defendants' counsel to submit a written offer to plaintiffs' counsel and the Court with a brief explanation of why such a settlement is appropriate on or before 10/05/12. The settlement conference date may only be changed by the granting of a motion. Mailed notice (vkd, ) (Entered: 09/19/2012)

Gary D. Osborn and Apothecure Inc. Sentencing Continued to 10/3/2012

09/14/2012 54 ELECTRONIC ORDER as to Gary D Osborn, Apothecure Inc: Sentencing CONTINUED to 10/3/2012 02:00 PM in US Courthouse, Courtroom 1570, 1100 Commerce St., Dallas, TX 75242-1310 before Judge Barbara M.G. Lynn. (Ordered by Judge Barbara M.G. Lynn on 9/14/2012) (chmb) (Entered: 09/14/2012)