"Access to Life-Saving Drugs Act."

February 10, 2007 at 11:55 pm

Towards the end of January, I attended a meeting on Capital Hill with a number of consumer-patient organizations, to discuss support for Rep.Henry Waxman’s “Access to Life-Saving Drugs Act.” The bill would establish a process through which the Food and Drug Administration (FDA) will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. Biologics, biopharmaceuticals or biotech products, are drugs that come from living sources as opposed to chemically synthesized drugs. Plasmapharesis and IVIg amoungst many others would obviously fall under Biotech durgs

Currently, there is no statutory framework for the approval of generic alternatives to biotech drugs, even after all patents have expired more than 20 years later. As a result, the manufacturers of these drugs can charge monopoly prices indefinitely. Mr. Waxman’s bill would provide such a statutory framework, which could save patients and our health care system billions of dollars a year in drug costs and provide access to life-saving drugs to those who need them.

There is so much info, and it was an extremely interesting meeting. The whole thing dates back to 1984 when Hatch-Waxman Act ‘came into being’, and legislation was passed creating the competitive generic drug industry for synthetic drugs. Biologics was in its infancy then and was not included.

This bill will only give the FDA [B]authority[/B] to approve generic biologics. So …. this does not mean that if it is passed, that generics will be available immediately. It means that the FDA will be allowed to, legally, approve, under very specific guidelines, generic biotech drugs. I think they said that the FDA would be able to approve a generic on a product by product basis,. It could very well take many, many years before guidelines are established for biotech generics. Also, it should be noted that because biotech products are so complex etc, that there will not be tons of competitors as in the synthetic market. If there is one competitor for a generic bio drug, the savings would only be between 15 and 20% (or so), not the up to 80% as in the synthetic market. Sooooo …… this will really impact the healthcare providers, insurance co’s etc. and finally filter down to us, in as much as maybe some of our providers will agree to pay for our IVIg etc, if they have not done so in the past (one example is Blue Cross Blue Shield of CA, If i recall correctly, who would not cover IVIg).

There is a lot of interest in this at federal and state level, both for and against the bill. I’m sure you call all think of pro’s and con’s for this as well.
I am so tired at the moment, I just cant think straight. I apologize if I didnt make sense, or muddled up my legal and political terminology. I just wanted you guys to be aware that there are people out there in government, who are fighting to try and get cheaper, life saving drugs approved for us. I thought I needed to let you know since there is this discussion regarding the cost of IVIg.