Friday, December 16, 2011

Senate HELP Committee Hearings on Drug Shortage

Yesterday I was able to watch some of a hearing online that the Senate Health, Education, Labor and Pensions (HELP) Committee held about the drug shortages. It was titled “Prescription Drug Shortages: Examining a Public Health Concern and Potential Solution.”

A couple of points that I got out of the portion that I listened to: 1) there is a drug shortage problem; 2) the FDA has been trying to address drug shortage problem(s) for many years; 3) they are going to continue to address the shortages and communicate with “stakeholders” to “mitigate” the chance of drug shortages in the future.

The above does not make me feel better about the situation and I felt like everyone was talking in circles. I downloaded all of the transcript documents which I am going to read this weekend and I hope that I will read about something actionable that the committee will do other than give the FDA a bunch of mandates.

I had the great opportunity to meet the President of the Illinois Medical Society, Dr. Wayne Polek, at my Rotary meeting on Tuesday. He addressed the club and talked about the Healthcare act in general, but that gave me an open door to ask about the drug shortage and tell him that cancer patients are not getting crucial treatments. He said that the drug shortage problem is very complex, and related to profitability, and the discussion was more than we had time for so I agreed to send him an email and we would correspond. I am interested in knowing what doctors are trying to do about this other than just tell their patients “There is no more medicine available.” Not only is that not very comforting to a cancer patient, it’s downright scary.

There should be more than one manufacturer that has the ability to make Doxil, so if that manufacturer isn’t keeping up with their quality control, then another manufacturer could step in and take over (and take the profits).

So yesterday, the Health and Human Services Department released a statement (as a part of the Senate hearing process I do not know) about President Obama’s Executive Order, and the FDA issuing a rule that will require manufacturers to report interruptions in production of critical drugs. Obama had already issued an executive order in October, so I guess they are just reiterating what they want to do to prevent future shortages. I honestly say that I don’t know if that will help or not, since the FDA hasn’t been able to keep an eye on the drug shortage ball in the last few years anyway.

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