Dr. Margaret Hamburg, FDA Commissioner, delivering the keynote address at the 2012 Interchange. Image courtesy of C-SPAN. Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines

.S. FDA Commissioner Hamburg Urges Physicians, Patients to Only Purchase Medicines from Reliable Sources to Better Protect Against Fake Drugs
Washington, D.C. (September 28, 2012) – The Partnership for Safe Medicines (PSM) today convened leading domestic and international stakeholders in the fight against counterfeit and substandard medicines, making a renewed commitment to work together and implement new solutions to protect patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg, in a keynote to the conference, highlighted new efforts her agency is undertaking to reduce the threat and pledged the FDA’s ongoing support to ensure a safe U.S. drug supply.
"The American people have every right to expect that the medicines they rely on are exactly what the package and label say they are – and that the medicines have been carefully evaluated by FDA for safety, efficacy, and quality," said FDA Commissioner Margaret A. Hamburg, M.D. "Our success in addressing this global challenge will depend on collaborating with public health and regulatory partners here in the United States and around the world."

PSM Executive Director Scott LaGanga.
Image courtesy of C-SPAN.

The event brought together more than 140 participants, representing government, health care, law enforcement and patient advocacy. This is the third year that PSM has hosted a global Interchange event in Washington, D.C.
“This year’s Interchange was our boldest, most ambitious effort to date,” said PSM President Dr. Marvin D. Shepherd. “By bringing together stakeholders from as far away as India and Great Britain to share information and ideas on how to win the war on counterfeit medicines, we are sending a message to counterfeiters worldwide: the noose is tightening, and you can’t hide forever. As regulators and law enforcement agencies in the U.S. and abroad come to grips with the great public health risk of fake drugs, our efforts and successes will only intensify in the future.”  To read more click here

New FDA hand-held scanner sheds light on counterfeits Agency might sell its patented device to other regulators September 27, 2012 | By Eric Palmer Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qKoVCa Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

Agency might sell its patented device to other regulators

September 27, 2012 | By Eric Palmer

Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qSCJAx
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Drug giants fined $11bn for criminal wrongdoing; Fines are not enough to reform drug industry, warn lawyers

The Independent has an article entitled Drug Giants Fined $11bn for Criminal Wrongdoing, written by Jeremy Laurance and published September 20, 2012.  To read this article click here.

Washington State Board of Pharmacy: Ther-Rx Corp Letter

The Washington State Board of Pharmacy had on its September 27, 2012 agenda to discuss:

3.10 Correspondence. The board may discuss any correspondence received or distributed. Information/Action.
a) Ther-Rx Corp. letter re: Compounding of Hydroxyprogesterone Caproate

Once the minutes to the meeting are posted, I will update you on what position the Washington State Board of Pharmacy has taken.

Another FDA lawsuit over Exclusivity

FDA Law blog is reporting  that there is another  Orphan Drug Battle in that Depomed has Sued the FDA Over GRALISE Orphan Drug Exclusivity.  The complaint and post can be read here.