A Legislative Debate Over Generics In Florida
3 CommentsBy Ed Silverman // June 3rd, 2008 // 9:21 am
A group of drugmakers are lobbying Governor Charlie Crist to veto a proposed study to compare the effectiveness of generics with brand-name meds, The Jacksonville Business Journal reports. The Coalition for Affordable Prescriptions says the study will be “intentionally written to deliver a biased conclusion that will keep FDA-approved, safe, effective and affordable generic prescriptions from Florida consumers.”
The proposed study was added in provisional language to the General Appropriations Act by state rep Ellyn Bogdanoff, a Republican from Fort Lauderdale, requiring the Florida Department of Health to commission a study of the Florida Pharmacy Practice Act, which outlines rules for pharmacies. So far, Crist has not acted on the measure.
Bogdanoff tells the paper she added the provisional language to get more info on the potential for some generics to cause negative reactions in patients suffering from serious conditions, such as organ transplant patients and epileptics. “A minor change in a drug can throw someone into an epileptic seizure if they don’t react well to that particular drug,” she tells the paper.
The provisional language, inserted late in the legislative session, calls for the department to form a panel to conduct the study. The Board of Medicine, the Board of Pharmacy, the Florida Academy of Family Physicians, the Florida Kidney Foundation and the Epilepsy Foundation of Florida will each select one member.
The coalition claims several brand-name drugmakers, which it did not identify, are pushing the study, and contribute heavily to the Florida chapters of the National Kidney Foundation and the Epilepsy Foundation. The coalition believes the the study “really is nothing more than a “smokescreen for particular brand manufacturers looking to monopolize on an otherwise free marketplace.”
“We don’t question the motives of the lawmakers that did it,” coalition spokeswoman Sarah Bascom tells the Journal. “We do question certain brand-name pharmaceutical companies that pushed for it.”
Research similar to that proposed for the health department study was conducted by the Florida Office of Program Policy Analysis and Government Accountability, a special staff unit created by the state Legislature that analyzed the substitution of anti-epileptic drugs, the paper writes.
Bogdanoff says she disagreed with the office’s findings and instead wants to see the department’s findings on the matter from a health-care perspective, the paper continues.
The coalition is satisfied with the findings of the office’s report, and claims the state would relinquish serious savings for Medicaid - about $52 million, according to Florida’s Agency for Health Care Administration - for patients switching from generics to brand-name meds. The coalition also argues there is potential for a market shift from generics to brand-name drugs, the Journal writes.
Florida statutes mandate pharmacists to substitute less expensive, generically equivalent drugs, unless the buyer requests otherwise, the Journal notes.
Many in the fight fear the study will push the state away from buying generics, but Bogdanoff said there is no evidence of that. If anything, the state is causing more competition between competing generics by mandating pharmacists to substitute generics for brand-name drugs. “We are artificially inflating the cost of generic drugs,” she tells the paper.
Dan
The Benefits of Generic Medications: Is the Efficacy There?
More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. 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 med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System. More likely, however, is that samples do, in fact, help out the 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 meds. Fast forward to 1984, 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 included in the approval process. The reduced cost of generic production allowed for more of these meds to saturate the 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 meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. 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. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
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 meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.
“What good fortune for those in power that the people do not think.” — Adolph Hitler
Dan Abshear
Medicaid Pharmacy Director
Close to 80-90% of epileptic medication use is off-label for other conditions such as behavioral health. So its natural that Pharma would seek to end generic substitution in that category. If 100% of epileptic medication was used for its intended purpose, this wouldn’t be an issue. No one wants to see a patient have a bad outcome with their epilepsy.
May payors already allow payment for brand and generic versions of what we call “narrow therapeutic index” drugs. Examples in this epileptic category would include Dilantin and Tegretol. As a rule of thumb, if you draw blood levels to establish efficacy/safety, then a drug could fall into this category and swtiching back and forth between brand/generic has the potential for problematic outcomes.
But in general, even with narrow therapeutic index drugs, use of generics is extremely safe as long as patients (1) don’t bounce between brand/generic version, and (2) make sure that their pharmacies are consistently using product from the same generic manufacturer every time their prescription is refilled.
Jack2
(2) make sure that their pharmacies are consistently using product from the same generic manufacturer every time their prescription is refilled.
I’m not poo-pooing generics. I think they bring great cost-savings for minimal risk. But the typical patient has no control over which generic brand they receive at the pharmacy, so I don’t think what you propose is possible.