Brand-name drug manufacturers have gone to extraordinary lengths to mislead doctors, pharmacists, and the public into believing that their products are produced to higher standards, and thus are safer and more effective than the same drugs produced by generic companies. These strategies have included setting up sham patient groups to lobby state legislatures to protect their brand-name drugs, and the suppression of scientific research by at least one brand-name company that showed their brand-name product was no better than those of generic companies.

The quality of prescription drugs, brand-name or generic, does not depend solely on the manufacturer but also on a strong and vigilant FDA. Both brand-name and generic drug companies are regulated by the FDA using the same standards for manufacturing facilities, quality and purity, and content of prescription drugs.

The Question of Brand-Name Quality

Many brand-name drug companies such as Warner-Lambert and its subsidiary, Parke-Davis, denigrate the quality of generic drugs in an attempt to hold market share from generics and protect profits. However, the facts about this brand-name manufacturer bear examining.

From 1990 to the end of 1995, there were a total of 64 recalls of Warner-Lambert products as listed in FDA recall reports. In 1990, there were 3 recalls, 1 in 1991, 3 in 1992, 24 in 1993, 13 in 1994, and 20 in 1995. For their brand of phenytoin (DILANTIN) alone—a drug used primarily for treating seizure disorders and one where the amount of drug in the blood is critical—there have been 12 recalls during this period. Nine of these involved problems with dissolving of the drug, which can result in an insufficient amount being absorbed by the body. More than 975,000 bottles (some of which contained 1,000 capsules) and more than 30,000 injectable doses of Dilantin were affected by these recalls.⁴

In this case, Warner-Lambert officials pleaded guilty to criminal charges for withholding important information about sloppy manufacturing practices from the FDA.

FDA Repels Attacks on Generic Drugs

As discussed above, it is in the first seven years after approval—when there is never any generic equivalent available because the patent has not yet expired, that most drugs are found to cause serious problems, not infrequently leading to their removal from the market.

Examples of such disasters, which collectively have killed hundreds of Americans and injured thousands more, have involved the arthritis drugs or painkillers Oraflex, Suprol, and Zomax; the antidepressant Merital; the high blood pressure drug Selacryn; the diet drugs Pondimin, one-half of the once popular “fen/phen” combination, and its close chemical cousin Redux; Posicor, a drug for high blood pressure and chest pain; the diabetes drug Rezulin; and the painkiller Duract. Because of the serious dangers of these 10 drugs, all were taken off the market.

But what about those drugs that have been on the market for a long enough time for the patents to have expired and that are available in both brand-name and generic versions? Which version is safer or more effective? It has always been our position that there is no difference between generic and brand-name drugs as far as the odds that there will be something found wrong with the amount of active ingredient or the purity. Over the years, there have been recalls because of these kinds of problems with both generic and brand-name drugs.

A 1990 study by FDA laboratories from all over the country found that for those classes of prescription drugs that theoretically could be most likely to pose safety or effectiveness problems if they were not manufactured properly, the generic drug met the applicable standards in virtually all cases. The classes of drugs tested included contraceptives, antibiotics, and medications prescribed for asthma, epilepsy, high blood pressure, and abnormal heart rhythms. Of the 429 samples of the 24 different drugs tested, including both brand-name and generic drugs, there were no samples tested that posed a health hazard to patients when examined for potency and, where applicable, dissolution rate and content uniformity.

The reason that these 24 different drugs were chosen is that they all have a narrow therapeutic range. This means that unlike with most kinds of drugs, for which there is a relatively large range of dosages that are both effective and relatively safe, the amount of these drugs that gets into the body must be more tightly controlled. If it is not, the drug may too easily lose its effectiveness (if the dose is too low) or become toxic (if the dose is too high).

The drugs that tested included six asthma drugs, four for treating epilepsy, four high blood pressure drugs, four drugs for treating heart arrhythmias, a birth control pill, one antibiotic, a drug for treating depression, and a so-called blood-thinning drug. In six categories of drugs, both brand-name and generic versions were tested. In the case of the birth control pill, all of the major brand names, but no generic version, were tested.

For 23 of the 24 different drugs, there was no difference between the brand-name and the generic versions in the FDA laboratory tests for purity or quality. For aminophylline, an asthma drug that we do not recommend as a first-line treatment, five batches from two manufacturers failed to meet the FDA standards. Although none of these five batches posed a health hazard, all were recalled.⁵