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Update 5/17/2018: The FDA has now launched the website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives. You can view the list here. It includes notable medications, such as Accutane (for acne), Methadone (used for opioid dependency), and Tracleer (to treat high blood pressure in the lungs). The brand name drug makers to be shamed includes big hitters such as Celgene Corp, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, Gilead Sciences Inc, and Actelion Pharmaceuticals Ltd, now a Johnson & Johnson company. Our original story, published May 16, is unedited below.
The Food and Drug Administration plans this week to effectively begin publicly shaming brand-name drug companies that stand in the way of competitors trying to develop cheaper generic drugs.
FDA Commissioner Scott Gottlieb told reporters on Monday and Tuesday that the agency will unveil a website on Thursday, May 17 that names names of such companies. More specifically, the website will publicly reveal the identity of 50 branded drugs and their makers that have blocked generic development. The website will also be updated "on a continuous basis" to list additional names.
In fielding questions from reporters, Gottlieb denied that the effort was a form of public shaming. "I don't think this is publicly shaming," Gottlieb said, according to S&P Global Market Intelligence. "I think this is providing transparency in situations where we see certain obstacles to timely generic entry."
(Score: 0) by Anonymous Coward on Monday May 21 2018, @01:34AM
First I want to clarify something. Latuda and amitryptiline are two different drugs. What MDC is talking about is not a difference of generic vs branded effectiveness.
As for your question, when it comes to treating your condition, there is no real difference between generics and branded. Generics are just as safe and effective as branded drugs in every real sense. The difference comes in two places. The first is when the drug reaches dosing level in your blood, which can vary depending on the exact formulation and cannot be more than a few percentage points from the branded drug. For standard ingested drugs, the difference is literally seconds. However, that can cause people to have placebo reactions that magnify the actual difference. The second is side effects. Generics can have different side effects from their branded counterparts because the INACTIVE ingredients can be different. Usually they just use cheaper fillers (AKA bulking agents) but other excipients can be changed as well (as long as it doesn't affect the AUC/timing too much). Again, even slight changes in side effects can be magnified by the placebo effect, but if you check the inserts, they are usually minor (think slight indigestion). Really, the only time you need to be extra careful is when you switch between drugs, e.g. branded to generic, generic to generic, or generic to branded.
A good video on the subject is here: https://www.youtube.com/watch?v=vqXrfzWgDkE [youtube.com]