Friday, October 12, 2007

Generic Drugs

I was on my way to the office this morning when I heard this NPR story "Study: Generic Anti-Depressant Ineffective by Joanne Silberner".

It is extremely rare that I don't mark the box --allow generic substitute -- on the prescriptions I write. When I am the patient, I ask for generics. So this news report gave me pause. According to the FDA, the definition of a generic drug is:

"A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price."

The same FDA page goes on to reassure:

"Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products"

I am like "Cheryl" in the NPR story, I am a fan of generics. Still if you (and your doctor) do not feel that you are getting the benefits expected from your prescription, you may want to try the "name" brand.

1 comment:

Anonymous said...

Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present, cure the disease, as with the case regarding antibiotics, or the provider may prescribe medications to delay the progression of a disease that may exist with their patient.
The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:
More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate. Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned. Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.
Generic medications are copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost
Why aren’t generic medications prescribed all the time, then? The branded drugs have representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result. Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.
Around 4 billion prescriptions filled every year, so cost savings is rather important. Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market. However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.
With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs. Finally, about half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.
Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible. This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications. Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.
Not long ago, generic drugs 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 clinical trial protocols as branded meds.
Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA. This reduced cost of generic manufacturing and approval allowed for more of these meds 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 altering their existing branded medication by combining it with another generic drug from another class of medications. This tactic is referred to as evergreening, and the tactic extends the patent life of their branded drug of concern.
Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication they wish to continue to promote.
The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs.
Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access into a market they believe to own. Recently, branded pharmaceutical companies have either purchased smaller generic drug companies, or have started to produce generic medications on their own. This is due to the progressive impact generic drugs are having on the business of branded drug companies.
Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.
Newer drugs at times are not a desirable choice of treatment for patients because of understandable concerns by the prescriber, such as safety that has not fully established with a new medication. The familiarity of the generic drug accessible to them after the patent expiration of a branded medication the prescriber has utilized often in the past with treatment success for their patients allows the prescriber to utilize the generic equivalent not that it is available often.

Many clinical studies have proven that generics are as effective compared with branded medications for particular disease states.
The cardiovascular disease trial called the ALLHAT trial showed this. In this trial, with surprise to many, the old class of drugs called diuretics showed equivalence if not superiority over the branded medication utilized in this trial. This comparative effectiveness trial lasted over four years, and was funded mostly by the NIH.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter drugs. This may discourage the use of branded equivalent drugs at a greater amount with generic samples available with this method. In addition, and in some cases, doctors can order generic samples from the manufacturers directly. Both mechanisms for obtaining samples of generic drugs by a health care provider remain quite rare, however.
Then there are some health care providers who insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic medications. This misconception is a fallacy, as both are bioequivalent, since the generic drug has to show this in order for the drug to be authorized for use by prescribers. I’m sure it’s possible others have encouraged such doctors to take such a stance that is absent of evidence. However, there may be some truth to decreased efficacy of generic drugs over their previously branded equivalents, yet not to the point where it is a clinical concern.
In the U.S. Health Care System, cost is a rather large concern for members of the public health, and those who attempt to restore their health as it needs to be at times. Generic medications provide financial relief for patients in need of drugs to improve their health. And both the health care provider as well as the patient can be assured that a generic drug prescribed to, and taken by, a patient will provide the efficacy needed to address the medical problems of the patient. More importantly, the patient saves money, without compromising their safety,

Dan Abshear