As blogged earlier this week, the Senate Healthcare, Education, Labor, and Pensions committee met this week to discuss the pharma supply chain and Senator Barbara Mikulski (D-MD) had some interesting comments about making supply chain concerns a national security issue. Below are highlights from her remarks, including a Q&A portion with FDA’s Deborah Autor, as sent to PharmTech by the Senator’s press office.
SENATOR MIKULSKI: At this hearing, I have several hats. One of which is as the Senator from Maryland – where FDA is headquartered. We’re so proud of the work you do under difficult circumstances: the limited funding and contradictory requirements that you’re given.
I’m also here as a member of the Intelligence Committee; and as Chairwoman of the Commerce Science Justice Appropriations subcommittee.
I believe that adulterated drugs coming into this country is criminal, it is a form of murder. People can no longer rely on prescription drugs and have any level of certainty that what they are ingesting can be the very thing that saves them from a stroke, a heart attack, or a diabetic coma. Instead, what they’re ingesting could be the very thing that kills them.
We’ve got to get real, we’ve got to get serious and we have to have a sense of urgency. That’s not laying it on the FDA, that’s laying it on us. We throw zillions at the Defense Department to protect the homeland and fight them over there so they don’t kill us here. We’ve got to have that same attitude toward those who are adulterating over there, quite frankly, so that they don’t kill us here.
Now, your [Dr. Deborah Autor, Deputy Commissioner for Global Regulatory Operations & Policy at FDA] background is terrific. You’re a trial lawyer, you worked at the Justice Department and you have an incredible background in working with federal law enforcement.
Here is my question to you. What are we going to do in order to create this sense of alarm – red alert, holding onto the edge of our chair, DEFCON 3 – because this is a growing problem?
This is not exaggerated hyperbole for CNN. This is a compelling need when we take into account the number of people who take prescription drugs, in which we are now so vulnerable and which are usual and customary drugs. Particularly the issue of blood thinners.
So my question to you is are we moving with that sense of urgency? Has this been escalated to a homeland security issue? Is this the top of anyone’s agenda?
This is about protecting our borders, as we do from anything else illegal or threatening coming into our country.
DR. AUTOR: Thank you for that question. I really appreciate, and I really do share your sense of urgency.
I worry about products like this, which frankly, cross our border every day. This is counterfeit Tami flu and counterfeit Lipitor, and you’re welcome to look at it if you like. They look very, very similar and they come into this country.
One important thing that your question gets to, Senator Mikulski, is the fact that the risk to the pharmaceutical supply chain is not simply from people who are out to make a buck. There is a risk from people who have much more malevolent motivations, and I think we need to be made aware of that.
And so I do everything that I can to reach global facilities to change what we’re doing at the agency, to be more proactive, to be more creative, to collaborate. But there are things which are not in the law such as clearly requiring manufacturers to update their test standards to look for vulnerability.
SENATOR MIKULSKI: Especially making them criminal charges. I mean really we have to do some out of the box thinking here. It’s not are you for regulations or against regulations. We’re for smart regulation.
DR. AUTOR: I completely agree and with respect to another crisis like Herapin or something like it — it’s not a matter of if, it’s a matter of when.
SENATOR MIKULSKI: Let’s talk about FDA, Justice and the Department of Homeland Security. Do they feel that this has a sense of heightened urgency? Has this moved up the chain that is looking at the supply chain of counterfeit drugs?
DR. AUTOR: I can’t speak for them. I’m not really sure I could answer that question. Sitting here today, I’d be happy to answer that for you.
SENATOR MIKULSKI: I just want our committee to know this. Senator Whitehouse was on the Intelligence Committee along with Senator Roberts. We see the growing nexus between international organized crime and the corruption of public officials overlooking any other kinds of collaborative enforcement. I don’t want to do complicated foreign policy here but I think we need to look at it.
I had a chance to talk with INTERPOL this summer and have extensive conversations about their digital databases and what they see as a growing problem.
This is an international problem. For any of us, who value safety and efficacy, this has to be elevated to a national security, homeland security and criminal level. I look forward to talking to my colleagues so that we approach it that way so that the American people can know that if they take a prescription drug, they’ll be ok.
The hearing can be watched online. http://mikulski.senate.gov/media/video/9-14-2011-v1.cfm
The full hearing included two panels. The first panel consisted of Dr. Deborah Autor, Deputy Commissioner for Global Regulatory Operations & Policy at FDA. The second panel included Dr. Marcia Cross, Director of Health Care at the US Government Accountability Office (GAO); Dr. Kendra Martello, Assistant General Counsel at PhRMA; Gordon Johnston, Senior Advisor for Regulatory Sciences at Generic Pharmaceutical Association (GpHA); Allan Coukell, BScPharm, Director of Medical Programs at Pew Health Group; and Dr. Martin VanTrieste, Past Chair at Rx-360, the international pharmaceutical supply chain consortium. Various US Senators on the HELP committee participated in the Q&A portion of the hearing.