NABP e-News: December 10, 2009

NABP Symposium Provided Attendees Opportunity to Discuss Medical Marijuana and Public-Private Partnerships
The NABP Symposium held December 3-4 in Tucson, AZ provided approximately 120 attendees with opportunities for education and discussion on the topics of the legalization of medical marijuana and public-private partnership benefits. Speakers on medical marijuana included Kevin Sabet, Office of National Drug Control Policy; Barry D. Dickinson, American Medical Association; and Caren Woodson, Americans for Safe Access. Richard Norment, National Council for Public-Private Partnerships; Janita Gordon, Arizona Community Foundation; and Kim E. Light, University of Arkansas for Medical Sciences College of Pharmacy and Arkansas Pharmacy Support Group headlined the presentations on public-private partnerships. Speaker presentation materials may be accessed on the NABP Web site.

International Spam Network Operators Charged by FTC and Ordered to Pay Millions 
On November 30, 2009, the Federal Trade Commission (FTC) announced the charges and settlements against two individuals behind an expansive international spam network responsible for promoting the fraudulent “Canadian Healthcare” brand name. The ringleader, a New Zealand citizen and Australian resident, admitted in December 2008 his involvement in the spam network, and a federal court has now issued a default judgment against him, his US accomplice, and three affiliated companies. The two men recruited spammers who sent billions of e-mails deceptively marketing prescription drugs in violation of federal law and the CAN-SPAM Act of 2003. The spam advertised FDA-approved drugs sold through licensed US Internet pharmacies with secure credit card processing, but the unapproved drug products were actually sold through unsecure, fraudulent Web sites and shipped from India. A federal judge ordered the ringleader to pay $15.15 million and the two are liable for several million more.

New Phishing Scam Claims Users Must Register for CDC H1N1 Vaccination Program 
On December 1, the Centers for Disease Control and Prevention (CDC) issued a public alert regarding a phishing scam in which fraudulent spam e-mail messages, claiming to be from the CDC, inform recipients that they must register for a statewide, CDC-sponsored H1N1 vaccination program. CDC emphasizes that the agency has not implemented a state vaccination program requiring registration. Further, users clicking on the link provided in the spammed messages are at risk of having malicious code installed on their computer. An example fraudulent e-mail is included in the CDC alert.

NABP Report Highlights Rise in Pharm Spam That Feeds Rogue Internet Industry
Advertisements for cheap prescription medications from so-called Canadian Internet pharmacies make up the majority of unsolicited e-mail messages, ie spam, which serves criminals by luring victims to fraudulent Web sites. Once linked to such sites, victims may reveal their personal and financial information, likely subjecting themselves not only to unapproved and potentially counterfeit medications, but also to credit card fraud and identity theft. Just by opening spam, victims risk inadvertently downloading viruses or malicious software, which enables criminals to use their computer to churn out more spam or to steal personal data, unbeknownst to the victim. NABP discussed these and other cybercrimes often perpetrated by the operators of rogue Internet drug outlets in a November 2009 report to state and federal regulators. Based on its review of nearly 5,000 Web sites selling prescription medications, NABP reports that 95% appear to be out of compliance with pharmacy laws and practice standards. The Internet Pharmacies section of the NABP Web site provides more information.

Discontinued Humulin 50/50 Available Until December 2009
Through the FDA Web site, Eli Lilly and Company has provided updated documents regarding the discontinuation of Humulin 50/50. The company estimates that Humulin 50/50 will be available at pharmacies through December 2009, rather than April 2010 as originally projected. Information for patients can be downloaded from the FDA Web site, and may be helpful to the approximately 3,000 patients currently transitioning to an alternate insulin therapy.

FDA Continues to Review Public and Stakeholder Comments Regarding REMS for Opioid Drugs
FDA continues the process of developing a Risk Evaluation and Mitigation Strategy (REMS) for certain opioid drug products. The agency is reviewing information received from the public and stakeholders over the past year during public meetings and comment periods. An Opioid REMS Steering Committee will review and consider all input, and future opportunities to submit information are as follows:

  • Written comments will be accepted until October 19, 2010. For more information see the Federal Register notice.
  • A public meeting with sponsors of relevant opioids was held on December 4, 2009.
  • An additional opportunity for public input will be provided before the REMS is finalized.

More information can be found in the Opioid Drugs and REMS update.