Today, more than 85 percent of U.S. prescriptions are for generic drugs, compared to 57 percent in 2004. The shift to generics has trimmed hundreds of billions of dollars from the nation’s rising health-care costs by counterbalancing the sky-high prices of new medications.
Insurers and government health plans strongly encourage or require the use of generic drugs. Even if your prescription indicates a brand name, your pharmacist is likely to give you the generic version if one is available—some states even mandate this—unless your doctor specifies “brand only,” “do not substitute,” or “dispense as written.” Some states also allow you to request that the pharmacist not substitute the generic drug. The brand-name drug will almost always cost you more, however.
Generic vs. brand-name: how similar?
As stipulated by the FDA, generics must contain the same active ingredients as the brand-name drug. They can contain different inactive ingredients, such as fillers and preservatives, and look different, but the dose, safety, and strength must be the same. A generic of a time-release drug may employ a different mechanism to gradually release the active ingredient.
For these and other reasons, generics may not be the exact bioequivalent of the originals.
The FDA does allow some leeway for generics (as well as for differences among brand-name drugs). Its reviews of thousands of studies have found that the absorption of generics differs from the brand names by only 3 to 4 percent, on average, comparable to differences among batches of many brand-name drugs. Such a small difference won’t matter for most drugs, but for some it may reduce effectiveness or safety.
Over the years, problems with generics have been reported with antidepressants, notably bupropion XL (brand name Wellbutrin XL), and anti-seizure medications for epilepsy, notably levetiracetam (brand name Keppra).
These isolated problems should not make you doubt generics, however. The vast majority are safe and effective. Some small variations among drugs, generic or brand name, are inevitable. To be on the safe side, keep the following tips in mind:
- If you switch from a medication (brand-name or generic) to a version by another manufacturer, be aware of any changes in your condition or side effects you may experience.
- Watch out, in particular, if you’re taking an extended-release drug for a condition that requires a constant blood level of the active ingredient and you switch to a version from another company.
- Watch for changes if you switch to a generic of a drug that has a narrow therapeutic window (meaning you can get in trouble if your blood level is a little too low or high). That includes thyroid medications, anti-seizure drugs, and the blood thinner warfarin (Coumadin). Ask your health care provider or pharmacist if your medication falls into this category.
Generic price surprises
As a general rule, prices for generic drugs go down over time. Once the patent on a brand-name drug runs out, one generic maker is granted exclusive marketing rights, typically for six months, so the price doesn’t drop that much initially. After that, as other generic makers step in, the price can eventually drop 80 or 90 percent or even more.
But thanks to mergers of manufacturers of generic drugs, various marketing shenanigans (including possible price collusion), and regulations that deter the entry of new competitors, prices of some older drugs have been rising, if not soaring.
Jaw-dropping price spikes for decades-old generics such as doxycycline (an antibiotic) and calcipotriene (for psoriasis) have made headlines. In the most egregious cases, companies like Turing and Valeant purchased old drugs—such as pyrimethamine (to treat toxoplasmosis) and isoproterenol (a heart drug)—that are produced by a single manufacturer and raised prices by up to 5,000 percent.
In 2016, a report by the Government Accountability Office (GAO) looked at nearly 1,400 “established” generic drugs covered by Medicare Part D and found that overall prices declined between 2010 and 2015, but that more than 300 of them had at least one “extraordinary” price increase (100 percent or more). Not surprisingly, competition—or rather, the lack of competition—affects generic drug pricing most, according to the GAO report.
Warnings Shrink or Disappear on OTC Drugs
Unlike ads for their prescription counterparts, direct-to-consumer ads for over-the-counter drugs are not required to present information about their risks—so it's important to read the small print on labels and package inserts.
This article first appeared in the UC Berkeley Wellness Letter.
Also see Buying Drugs Online: What to Know.
Published June 04, 2019