Conference: UNBRANDING MEDICINES: THE POLITICS, PROMISE, AND CHALLENGE OF GENERIC DRUGS

UNBRANDING MEDICINES: THE POLITICS, PROMISE, AND CHALLENGE OF GENERIC DRUGS

Sponsored by the Harvard Interfaculty Initiative on Medications and Society

Thursday, December 11, 5:00 pm -- 7:00 pm, Sever Hall 113, Harvard Yard

Friday, December 12, 8:30 am -- 6:00 pm, Tsai Auditorium, CGIS South S-010, 1730 Cambridge Street

A cross-disciplinary conference that will address the clinical, regulatory, economic, political, and cultural aspects of the generic drugs movement, featuring Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, Richard Crout, former Chief of the FDA Bureau of Drugs, Joshua Boger, founder and CEO of Vertex Pharmaceuticals, patient activist Jamie Love, patent attorney and generic drugs expert Alfred Engelberg, and faculty from Harvard Medical School, Harvard Business School, and the Departments of History of Science and Government of the Faculty of Arts and Sciences, among others.  Sponsored by the Harvard Interfaculty Initiative on Medications and Society.

To register for the conference or for more information please contact info@medsoc.harvard.edu or visit the conference website at:

www.medsoc.harvard.edu/generics

(h/t H-SCI-MED-TECH listserv)

Comments

[Dan]

The Benefits of Generic Medications

More now than in the past, generic medications seem to be selected more by prescribers at a much higher rate than in the past due to the issue of the high cost of branded drugs that many health care providers as well as patients understandably find rather unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such drugs that are provided at a doctor’s office from the sales reps who promote these drugs. Generics typically are not sampled due to lack of funds from the makers of generic medications. Yet generics cost a small fraction compared with branded drugs that are of bioequivalent to the branded drug that a generic copied. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded drug. Delays are experienced with bringing a generic drug to market due to the stalling effects of the makers of the branded med approaching the end of its patent life.
One stimulus for more generic drug prescribing is that certain managed health and prescription providers have been actually paying doctors to initiate switching their patients to generic medications if they are branded medications, if a generic drug actually exists for the branded one a patient may be taking and tolerating well. This may be due to a reaction of the activities of the pharmaceutical companies with branded drugs they promote offering similar inducements to health care providers frequently and often. Both activities are unfortunately legal in most cases, and therefore are allowed to occur. Yet many find the process of providing incentives to prescribers in such ways understandably unethical and inappropriate, as well as possibly having a negative effect on the well being of patients.
Not long ago, generic meds were not prescribed that often, or produced to a great degree, because of the cost of bringing such a med to the market, which at the time required the same protocols as branded drugs to be granted approval by the FDA. Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced, and this Act allowed generic drugs under development to only demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else included in the approval process that is required by branded medications to be completely developed and approved by the FDA was required for generics to be created and made available for patients. This reduced cost of generic production allowed for more of these drugs to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.
Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds through such tactics as reformulation, which is called evergreening, of their promoted drugs, which allows for them to continue the lifespan of their branded medication. Additional tactics implemented by pharmaceutical corporations, such as frivolous patent infringement lawsuits, delays generic availability for a longer period as well. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication.
Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall, it appears. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their availability. In fact, branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics, or have acquired generic pharmaceutical companies entirely to supplement their profits.
Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has been replicated by the generic medication by the prescriber. Newer drugs at times are not a desirable choice of pharmacological therapy for patients because of lack of comfort of the prescriber- with possibly safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known drug creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. And this book should be available to all health care providers for their access.
Most encouraging for even greater use of generic drugs is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded drugs, as now samples of generics may be available to health care providers for their patients. In addition, and in some cases, doctors can order generic samples from the manufacturers of such drugs directly. I consider both methods very beneficial for those patients who require medicinal treatment for the restoration of their health.
Yet some doctors insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic drugs. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as this is required for the approval of generic drugs. I’m sure it’s possible others have encouraged such doctors to take such a stance which is void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents, some have said. Yet most professionals agree the efficacy and safety of generic drugs are similar if not equivalent to branded medications that they have copied
Considering the health care crisis in our country and the over-priced treatment methods in our health care system in need of reform, such as the case with branded pharmaceuticals, generic medications should be considered as a treatment option when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of the aspects of the pharmaceutical system and request generic drugs when being prescribed a drug by their health care provider that may be branded and therefore more expensive, if a generic equivalent exists. As generic medications are an affordable asset to another’s health as needed , at a more reasonable cost to such a patient..
“What good fortune for those in power that the people do not think.” --- Adolph Hitler
Dan Abshear
Authors note: What has been composed above is based upon information and belief