Advocacy: FL generic drugs

The converse of compounded medications.

In June, a Florida appellate court reversed an earlier judge's ruling that a branded drug could be substituted with a generic drug, without consulting the patient or their doctor, even if this drug was not on the original substitution list approved by the FL legislature.

What this means is that patient rights have been protected by not allowing substitutions of drugs that have not been specifically approved by our Legislature (which represents We, the People).

The legal basis for this ruling is that the appellate court felt that it would be unconstitutional for a judge to replace the laws set forth by our Legislature. Several years ago, the Florida Legislature approved a list of generic drugs that could be substituted for branded drugs. This was based on the FDA ratings of the equivalency of these generics to their branded counterparts.

Since the time of the Florida law, there have been many additional generic drugs added to the FDA's list. The original Florida judge simply extended generic drugs allowed for substitution to include those in the current FDA list. The appellate court then overruled this decision, by stating that FL laws approved by the Legislature cannot be trumped by the federal FDA list. if additional drugs are going to be added to the allowed substitution list, the FL Legislature would be doing this, not the FDA.

This decision is important to people with neurological diagnoses especially, since substituion with generic drugs can lead to fluctuations in medication levels. This could have dire consequences in conditions such as, epilepsy. Our aptly name journal, Neurology contains an article about the risks of changing to various generic medications, as opposed to remaining on the branded drug or, even, staying on the same generic drug (made by the same generic manufacturer). The reason for this is that the FDA allows each medications to be within a drug level range. This means that when you are taking a medication and it is switched around, you may not have the same response that you did to the original (either the branded drug or one type of generic).

To sum this issue up, while generics are good because they are less expensive and are similar to the branded drug, there may be more variation when changing from one generic to another to another (as is done by retail pharmacies as their arrangements with the makers of generics change based on pricing deals).

For more on this, see the article from Neurology (used with permission from the publishers):

http://www.neurologique.org/Generic_Topiramate.html

So, let's try for some real advocacy together: patients, carepartners and neurologists.

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org