Go to your bathroom medicine cabinet and pull out one of your prescription drug bottles. It’s probably a complicated-sounding generic version of a drug, the name of which you can barely pronounce, right? You probably also believe that whatever its name, it’s the equivalent of the brand-name version you’d prefer to take but your insurance company won’t pay for. Silly you.
The Wall Street Journal this week ran an article in which they interviewed Stephen Schondelmeyer, professor of pharmaceutical economics at the University of Minnesota College of Pharmacy, who explained that generic drugs can have “A” or “B” ratings (kinda like those sanitary health grades you see on the front doors of New York and LA restaurants.) I generally avoid “B” restaurants. Little did I know that I was do nothing to avoid "B" generic drugs. Says Professor Schondelmeyer:
If the generic doesn’t have the exact bioavailability profile—meaning the drug is absorbed at a faster or slower pace into the bloodstream—then it will be B rated …
Dr. Schondelmeyer suggests that patients ask the first time they fill a certain prescription whether it is the A-rated generic equivalent. It will be 99% of the time. “If it’s B rated, you could ask the pharmacist to check with your doctor to see if it’s OK,” he says. “Usually, even with the B rated it will be fine.”
Except sometimes generics are not "fine".
According to Fortune Magazine, generic companies often use inactive ingredients that are lower in quality:
Those differences can affect what’s called bioavailability – the amount of the drug that could be absorbed into the bloodstream. As the American Heart Association recently noted, “Some additives traditionally thought to be inert, such as alcohol sugars, cyclodextrans, and polysorbate-80, may alter a drug’s dissolution, thereby impacting its bioavailability.”
Differences also occur because generic companies are not told how brand-name drugs are put together so they have to guess. The FDA is aware of this and allows for certain differences. As Fortune Magazine notes, the FDA’s “definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.”
For more differences between brand and generic drugs, see the Center for Justice & Democracy’s report, “America’s Unaccountable Generic Drug Industry: How Legal Immunity Could Be Making You Sick.”
Why unaccountable? Because since 2011, the U.S. Supreme Court said they are. See some of our earlier coverage here. In two recent decisions, the Court ruled that if a drug consumer is harmed or killed by a generic drug due to the drug’s inadequate labeling or defective design, the manufacturer cannot be held accountable in court; the injured patient has no recourse. The same immunity does not apply to the brand-name drug industry. In other words, whether or not you have any legal recourse for injuries caused by an unsafe drug depends entirely on whether you were prescribed a brand-name or generic drug, even though you probably had no choice in the matter.
To help close this safety gap, the FDA has proposed a new rule that will restore parity between brand-name and generic drug companies when it comes to their responsibilities for maintaining safe and up-to-date warning labels. And it would restore your legal rights as a drug consumer.
This rule should have already gone through but the generic drug industry is fighting back hard, delaying its adoption. And now it has joined with big PhRMA (the Pharmaceutical Research and Manufacturers of America) to try to weaken the responsibility and liability of the entire pharmaceutical industry. It is basically forcing the FDA to hold an all day public meeting on Friday to talk about this.
But you don’t have to attend this meeting to express your views. Go here, and let the FDA know you support its proposed rule. Let’s make this happen already!