Biologic drugs need strict oversight

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Many people in Augusta live with serious diseases every day, including cancer, diabetes, HIV/AIDS and arthritis. They depend on pharmaceuticals, particularly biologics, to live a better quality of life. As a patient battling lupus, I know that biologics are helping many people, and we need to make sure it stays that way. Biologics especially hold a lot of promise for patients with lupus since there have not been any pharmaceuticals introduced in the past 40 years designated to treat lupus.

Even though they hold promise, they are complicated because they are made up of living organisms and are typically injected. The process of creating a biologic is very complex and hard to replicate. Because it is nearly impossible to replicate the manufacturing process, a follow-on biologic (for comparison's sake, a "generic" biologic) will not be the same as an original biologic. Without proper testing, they pose a threat to people who depend on them.

Current scientific methods are unable to establish that biologic products made by two different manufacturers are identical. Any legislation establishing a regulatory approval pathway for follow-on biologics should require clinical trials to demonstrate that the follow-on product is safe and effective, rather than allowing an abbreviated approval process similar to generic medications.

With hope on the horizon for those of us with lupus -- a hope that we have not realized in 40 years -- I would hate to have a generic "equivalent" compromise my safety and others' because of inferior testing requirements.

Vera Butler, Augusta

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Bizarro
13
Points
Bizarro 08/21/08 - 06:49 am
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Congress and the FDA are both

Congress and the FDA are both dealing with the issue of "biologic" pharmaceuticals (mononclonal antibodies, and proteins often recombinant). The rise in generics is due to approval of new biologics in recent years and the ever increasing list of biologics losing patent protection. The generics will be held to the same high standards as brand, and for that reason there will likely be no great savings in costs. The nature of product is that whether brand or generic there is slight differences in batch to batch although the methods are reproducible and likely the same whether brand or generic.

deekster
24
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deekster 08/21/08 - 10:19 am
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Hold onto your socks. China

Hold onto your socks. China is the number one suppler of raw materials for drug manufacturing in the USA. Soon it will be our food as well. In 1960 we could feed the world, clothe and manufacture most of the world needs. No more. We have become a nation of consumers for the rest of the world. Look for more wars in the "interest of US security."

deramian@ctiseattle.com
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deramian@ctiseattle.com 08/21/08 - 10:37 am
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Will the author of this

Will the author of this letter please tell the readers which industry trade group she was approached by to write this letter, the local Georgia trade group or the national one in Washington DC.?

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