E-DRUG: 7 year rule for prescription of new drugs (5)
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Dear E-druggers,
Most new drugs are in the market when patent is about to expire or when 5 to 7 years only are available for them to recover R&D costs.
This is especially true for life saving innovative drugs or even for modified drugs with better efficacy. Most of the present innovative drugs are in category of biopharmaceuticals.
On one hand we want more innovation, more investment in R&D and on the other hand we are creating artificial barriers for prescribing new drugs.
The answer would be only to have stronger regulatory mechanism regarding pharmacovigilance in all countries.
regards
CK Aiyer,
Professor Pharma management
chandrarobert@yahoo.com.au
E-DRUG: 7 year rule for prescription of new drugs (6)
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Dear E-druggers,
We find a corollary of the so-called 5-year or 7-year rule for (extra
vigilant) prescribing of new drugs, in the essential medicines concept and
list of different countries. Developing such a list is based on not only
evidence of efficacy and safety of the candidate drug (as available from
well-conducted RCTs) but its tolerability, effectiveness and utility also
(that are not usually available from statutory pre-marketing, regulatory
RCTs).
The last named criteria are not available until the drug managed to
exist a few years in general use. That is the reason why we find most of
the drugs in any EML, if not almost all, are patent-expired.
The key message that emerges from this 7-year rule is robust post marketing
monitoring as well as careful vigilant prescribing and a constant and
dynamic cross-talk between these two activities.
regards
Dr Santanu K Tripathi, MD, DM
Professor & Head
Department of Clinical & Experimental Pharmacology
Calcutta School of Tropical Medicine
Kolkata 700073
Email: tripathi.santanu@gmail.com
Phone: +91-9230566771
Dear E-druggers,
What specific "artificial barriers" are we creating? They need to be examined one by one in terms of rewarding companies for developing clinically superior drugs against hard end points after there are 3-4 choices within a therapeutic class. What evidence documents how a given measure serves as a "barrier"?
Current regulatory policies strongly reward companies to develop primarily minor variations that are undertested for risks of harm. Companies have been flooding the market with scores of new, minor variations for years and then spending billions to persuade doctors to prescribe them. These minor variations consume about 80 percent of all increased costs, not the 10-15% of therapeutic advances approved. See the article in the August 11 issue of BMJ by Light & Lexchin, and its references, at pharmamyths.net.
There's plenty of R&D now but largely focused on quicker, cheaper, and less risky minor variations that then command patent-protected prices. Of course, another way to encourage real innovation is to decide, as Germany, Australia, and other are doing, to only pay more for clinically superior drugs.
Don Light
PS It's also a misleading myth that market exclusion from normal price competition ends in 5-7 years. That may be true for the first patent, but does not count the many ways market protections are extended well past then.
Donald W. Light
Cell: +1-609-216-0071
Professor, UMDNJ-SOM
Visiting Researcher, Center for Migration & Development, Princeton University
Resident Fellow, Edmond J. Safra Center for Ethics, Harvard University
Senior Fellow, Center for Bioethics, University of Pennsylvania