Supreme Court rulings on 5-4 votes in both Pliva v. Mensing (2010) and Bartlett vs. Mutual Pharmaceuticals (2013) gave generic drug makers virtual carte blanche to injure people at will without having to face the consequences of the drugs they make. The latter ruling overturned a $21 million verdict for Karen Bartlett, who was blinded and disfigured by a generic version of sulindac, an anti-inflammatory drug.
Gross injustice like that in Ms. Bartlett’s case continues. The Supremes’ decision in favor of generic drug makers is a gift to drug companies that keeps on giving. Thanks to the high court, it is now either extremely difficult or virtually impossible for people hurt by the generic version of a drug to have their grievances heard in an American courtroom.
In addition to the fact that generic drugs fail to compare with branded ones in the American court system, there is much evidence to suggest that many generic drugs are not equivalent to brand name drugs from a medical perspective.
Fortune magazine reported in January 2013 on several controversies surrounding brand and generic drug “equivalence.” Katherine Eban wrote a story which detailed how in 2012 the FDA took the rare step of declaring that a generic version of the antidepressant Wellbutrin – which the agency had previously approved – was not in fact “bioequivalent” to the name-brand version. In that case, the FDA withdrew its approval of that generic Wellbutrin.
Teva Pharmaceuticals (which made out like bandits in the Mensing v. Pliva decision over the generic version of Reglan), marketed the Wellbutrin generic in question. Teva was forced to stop selling it. Other drug companies are now testing their versions of Wellbutrin at the FDA’s request. Fortune reported that the episode brought momentum to a movement that was quietly building among many doctors and medical societies increasingly willing to ask whether generic drugs are in fact identical to the brands they try to copy.
Most people tend to think that generic drug versions are the same as their brand-name counterparts. Most people are happy to save some money at the pharmacy counter and not think past their pocketbook as they leave the drug store. Some people may be vaguely aware that generics are often much cheaper because generic drug makers don‘t have to spend as much money as brand-name drug makers to get their drug on the market. Most are likely unaware that the differences between brands and their generic versions can be significant.
The issue is a large one, because a whopping 80 percent of all U.S. prescriptions now dispensed are generic. In 20112 alone, Americans saved $193 billion by buying generic drug versions, according to the Generic Pharmaceutical Association.
Generic drug makers may know some of the declared ingredients of a brand-name drug, but proprietary privilege helps the branders keep their processes secret. The patent that reveals the components does not explain how to make the drug. Consequently, generic drug makers must use reverse engineering to conjure their concoctions, hardly a panacea for perfection. The result is that a generic drug, is at best, an approximate copy, never a clean duplicate; and a generic drug will not behave in the same fashion as the branded drug will.
Though FDA rules acknowledge generic drugs’ duplication problems, the agency is a long way from solving them. The best the FDA can offer is a broad definition of “bioequivalence.” Fortune notes that “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.”
In addition, though the generic must contain the same active ingredient as the original, additional ingredients – excipients – can be different and are often of lower quality. Those differences can affect a drug’s bioavailability. The American Heart Association has noted, “Some additives traditionally thought to be inert (may) alter a drug’s dissolution, thereby impacting its bioavailability.”
Are Generic Drugs really the same as Brand?
FDA standards also don’t regulate how quick medicine reaches peak concentration in the blood, and patients taking time-release drugs can be seriously affected by peak changes. Active ingredients releasing into the blood far more quickly can leave patients dizzy or nauseous.
The FDA is also somewhat hogtied by Chinese producers of generic drugs. The Chinese don’t allow U.S. FDA inspectors inside their plants. Officials from the U.S. can only show up at the plant, wait outside, and then accept (or not) whatever the Chinese generic drug makers give or tell them.
An estimated 80% of active drug ingredients and 40% of finished medications come from overseas, from some plants which the FDA has not inspected. In November 2013, generic Lipitor maker Ranbaxy Pharmaceuticals recalled some 480,000 bottles after tiny shards of glass were found inside pills. India’s largest generics company, Ranbaxy is the same entity for which the FDA granted permission to produce a version of Lipitor. The approval came after a seven-year investigation in which the U.S. Justice Department concluded Ranbaxy had fabricated drug-approval data. Ranbaxy agreed to pay $500 million and entered into a consent decree.
This is hardly the stuff which can help make people feel confident in filling their prescriptions with generic versions of brand-name drugs.