Last Friday I attended the first annual Partnership For Safe Medicines (PSM)Interchange 2010 event. PSM is a coalition of organizations that are committed to the safety of prescription drugs and protecting consumers against unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines. PSM was started a few years ago to help educate healthcare professionals and the public about the dangers of counterfeit and other illegitimate drugs. It is based in Vienna, VA but focuses on the problem globally. The membership is made up of professional organizations from industry, universities and government.
PSM is led by a distinguished panel of leaders and directors. The leaders are:
- Marvin Shepherd, PhD (President) of the University of Texas at Austin, College of Pharmacy,
- Bryan Liang, MD, PhD, JD (Vice President) of California Western School of Law, University of California San Diego School of Medicine, San Diego State University, and Western Michigan University, and
- Thomas Kubic, (Treasurer) of the Pharmaceutical Security Institute (PSI)
To serve as a kind of mission statement, PSM has developed what they call the “International Principles of Drug Safety”. It calls for actions to secure and protect the drug supply chain in all countries, regulate internet drug sellers, and unify the global fight against counterfeit drugs (click here for the details).
One of my favorite things about PSM is their weekly newsletter that contains the latest news related to counterfeit drug incidents and regulatory actions from around the world. You can subscribe to it on their home page.
The Interchange 2010 event was held in Washington D.C. It was attended by about 100 people from industry, universities, government agencies, solution providers and the media. The program was broken down into three panels labeled “Who’s Getting Hurt by Counterfeit Drugs?”, “Who’s Benefiting From Unsafe Drugs?”, and “Who’s Making Progress Against Counterfeit Drugs?”.
FDA COMMISSIONER SPEAKS ON COMBATING COUNTERFEIT DRUGS
The keynote address was delivered by Margaret Hamburg, MD, Commissioner of the U.S. Food And Drug Administration (FDA). The text of all of Dr. Hamburg’s speeches are published by the FDA on their website (here), but you’ll have to wait up to a month because that’s seems to be about how long they take to update the website. Here is her speech in video form from C-Span. I’m not going to try to provide a complete overview of her comments, but there were several things that stood out to me.
Update, 10-18-2010: PSM has posted the transcript here.
Dr. Hamburg said that one of her chief priorities is to accelerate the transformation of the FDA into a public health agency that is able to meet the challenges of the 21st century. She reiterated that their recent SNI guidance was the first step toward a track and trace and authentication system. She said that the FDA needs new regulatory tools to protect citizens from harmful drugs and medical products and they look forward to working with Congress on new legislation that will give them the authority to do that. She mentioned that FDA has organized a new “Drug Integrity and Security Program” based in the Office of Compliance within the FDA Center for Drug Evaluation and Research (CDER) that will focus on counterfeit drugs, diversion, economically motivated adulteration (EMA), cargo theft and other supply chain threats. She said that FDA is “reconstituting” their internal counterfeit working group to help better coordinate their efforts across the agency. (I didn’t know they had disbanded it.)
Dr. Hamburg emphasized that the FDA cannot work in a vacuum and that global problems like these need international solutions.
Dr. Hamburg also said that the FDA has recently built a list of 1000 pharmaceutical active ingredients that they ranked by their likelihood of being the target of EMA. This is one of the actions in response to the Heparin adulteration case from 2008 and others. The ranking will help them prioritize FDA’s attention in the hopes of catching the next EMA crime before it can reach patients.
One of the more fascinating presentations was given by Rick Roberts, professor at the University of San Francisco, who was a victim of counterfeit drugs back in the early 2000’s. Mr. Roberts was diagnosed with HIV Wasting Syndromeand was prescribed Serostim as the treatment for it. He always bought his medicine from a national chain pharmacy, but about half way through his treatment he noticed that the injection site began to sting—something that had never happened before. When he asked his pharmacist about it he was told to check the lot number because there had been a counterfeit lot introduced into the legitimate supply chain. Turns out, he had taken injections from that counterfeit lot. Hearing Mr. Roberts’ story in his own words was very powerful. Watch him here, starting at minute 10:15.
Another panelist was Pulitzer Prize-winning investigative journalist Walt Bogdanich of the New York Times who spoke about some of his experiences investigating counterfeiting crimes. Watch him here, at minute 25:50.
Other panelists were from the Men’s Health Network, the American Pharmacists Association (APhA), the FDA Office of Criminal Investigations (OCI), the Drug Enforcement Administration (DEA), National Association of Drug Diversion Investigators (NADDI), U.S. Department of Commerce Office of Health & Consumer Goods, U.S. Centers for Disease Control & Prevention, the Irish Medicines Board, the Healthcare Distribution Management Association (HDMA), and the U.S. Immigration & Customs Enforcement (ICE) National Intellectual Property Rights Coordination Center. C-Span covered the entire event so if you are interested in watching any of these speakers, start here.
During the program, Scott LaGanga, executive director of PSM, introduced Mr. Bejon Misra as the interim head of PSM-India, an extension of the organization in India that was finalized only a few weeks ago. Mr. LaGanga noted that PSM is in discussions with people in several other countries about possible PSM affiliates.
WHAT DOES IT ALL MEAN?
PSM’s primary stated goal is one of awareness of the problem of counterfeit and other illegitimate drugs around the world. As a partnership between industry, academia and government, PSM has just begun to fill this important role in the fight against illegitimate drugs in the U.S. and elsewhere. My hope is that it will serve as a source of unbiased information and ideas for engaging in that fight. Until PSM came along, the only sources of this kind of information were GS1, industry organizations and solution providers. In my view, these sources hold too many biases of one kind or another to find the right solutions.
Yet PSM’s “International Principles of Drug Safety” is essentially a list of broad-stroke solutions. Oddly, this first PSM Interchange was short on specifics and short on discussion of any solutions.
And so I have to admit to a couple of slight concerns I have about PSM. Most of the talk at the Interchange was about the problem of illegitimate drugs being sold on the internet, but this was occasionally intertwined with talk of illegitimate drugs in the legitimate U.S. supply chain. Everything seemed to get thrown in together. I fear that there may be a big mis-understanding about the extent of the counterfeit drug problem on the internet compared with the extent of the problem in the legitimate supply chain, at least in the U.S.. I worry that, if not clarified, it will result in proposed solutions that do not match these realities.
I also worry that solutions raised by PSM and others to U.S. supply chain counterfeit drug problems will be based on the supply chain that existed in the early 2000’s rather than the one that exists today. The difference being a significant transformation caused by the transition from a “buy-and-hold” distribution model to a “fee-for-service” model, and the “voluntary” closing of pharmaceutical secondary market trading business units by the major U.S. drug wholesalers. Until we begin to hear specific solution ideas from the PSM, we won’t be able to tell if they recognize the significance of those changes or not.
PSM should strive to provide context as they raise awareness of the problems so that solutions can be targeted squarely on the real problems and not just an alarmist image of them.
These are only slight concerns and I certainly see the potential for positive outcomes. I will continue listening to PSM, and I will continue to hope for the best.