Why are so many of us Overpaying for our Prescription Medicines?
Give Us Generic Drugs For Our MS Treatment!
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The first therapy for MS (Interferon beta-1b) was made available to us nearly 20-years-ago now. It was followed, in relatively rapid succession (over the next ten years) by two other interferon therapies and Glatiramer acetate. Most recently, a monoclonal antibody has been added to our MS arsenal.
These are all compounds known as biologic drugs, meaning that they are grown, not synthesized. They must be grown from living cell cultures in a controlled environment with great care and at great cost. These drugs are not the “0 Million for the first pill, $.05 for the rest.”
A cost which is, as we know, passed along to the consumer...us.
Like all drugs, they are patent protected so that the proprietary company can recoup research and development expenses and return a profit to shareholders. Sounds like a free market system, right?
Biologic drugs, however, are not treated the same as other drugs. Their patents are much longer than other drugs (as the cost of development and productions are higher, there is more to recover). Some, myself included, think that these patents are excessively long; but that isn’t the only issue.
There is currently no statutory pathway for the Food and Drug Administration (FDA) to approve safe, lower-costing generic (known as follow-on in the biologic drug world) versions of these drugs.
In other words: Science is so far ahead of the law (and remember, this issue is over 20-years-old now) that congress has not given FDA the legal authority to review /or approve follow-on biologics!
If it can be proven that comparable biologic drugs can be, on the basis of safety and effectiveness (in addition to whatever additional evidence that FDA scientists determine necessary) that there are no clinically meaningful differences between the two products than, for pity’s sake, let us treat our multiple sclerosis at a reasonable cost!
And no, after nearly two decades, tens of thousands of dollars per year IS NOT REASONABLE!!!
In a meeting with my congressman’s senior staff this week, I was told that the Senate Health Care Reform Bill (which is currently at the Congressional Budget Office – CBO – for review) has a provision to reduce current biologic patents from 20 years but only down to 16 years. And, even after that still excessive period, there still is no mechanism for the FDA to approve follow-on formulas.
We seem to be going backwards!
It’s time, my friends, to take a stand. No matter your opinion on health care reform I think we can mostly agree that the FDA needs to be given authority, under the Public Health Services Act, to review and approve more affordable versions of our MS drugs.
This pathway should promote competition and eliminate unnecessary roadblocks and hurdles. Legislation should also provide a fair period of market exclusivity to the innovators of such drugs to protect their (substantial) investment.
I urge each of you, even if you’ve never called, written or e-mailed your congressional representatives before, to get in touch and let them know your opinion on this issue.
Wishing you and your family the best of health.
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