Thursday, June 7, 2012

ASCO Drug Shortage Session

First in a series of reports on the sessions I attended at the Annual  ASCO meeting. 

I attended the Drug Shortages:Why is this happening and how can we treat our patients session at ASCO presented by Dr Kantarjian, Mr Neas and Dr Schilsky.

How has the shortage of chemo drugs affected the treatment of patients?
Most generic drugs do not have real alternatives that patients can be given. So this has created problems for the regular treatment of cancer patients and those on clinical trials. Oncologists can delay treatment which increases patients anxiety. Onocologists may also choose to use an alternate drug but that drug may not be as effective nor will the provider necessarily have experience administering the drug or be as familiar with the side effects of the drug. If the patients are switched to the brand-named drug then drug companies may require higher copays or patients may have to pay the cost out of pocket.

If there is a shortage is of a drug being used in a clinical trial the accrual of patients may have to be lowered or the trial might be stopped all together. If the drug is switched that might be a violation of the protocols of the trial and my confound the data.

What about the gray market or counterfeit drugs? 
The gray market is made up of secondary drug distributors. These distributors might hoard drugs and then charge exorbitant prices for the drugs that are in short supply.
As you may know counterfeit Bevacizumab was provided to wholesalers who then sold the drug in the US. This is an international problem not just a problem in the US.

Why can't other pharmaceutical companies just pick up the slack?
It takes 1 and a half years to build a sterile injectable facility. So even if a company decides now they want to produce a drug that is in short supply it will take over a year and a half and FDA site approval before any drug can be manufactured. What if a company already produces other sterile injectable drugs in an FDA approved facility the process must be approved by the FDA before the drug can begin to be manufactured.

What does the future holds?
A recent federal law will require companies to provide a 6 month notification of a shortage or plant shut-down.
Pharmaceutical companies have provided the FDA with $1.5 billion to help shorten the approval process of the manufacturing facilities.

Recommended by the speakers was further FDA approval of foreign manufacturing facilities and
the establishment of a pricing floor for generics.

After listening to the speakers I was pleased to see the active part that ASCO took over the past few months in resolving the drug shortage issues.

Every Day is a Blessing!

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