How safe are generic drugs?
Generic. For people of a “certain age,” it conjures images of black and white packaging on products of questionable quality. But today, when it comes to prescription and over-the-counter (OTC) drugs, many American’s have come to accept generics and appreciate them for the substantial savings they represent. In fact, according to CNN, generic drugs account for an estimated 80 percent of all prescriptions.
But what are we getting when we choose a generic version of a prescription or OTC drug? Is it really the same? FDA guidelines require that pharmaceutical companies show that their generic product has exactly the same active ingredients, works as well as the brand-name, and has the same labeling. (More on this below.)
While the products are essentially the same, there are key differences.
Ingredients
Branded and generic drugs can contain different inactive ingredients that may alter their look and taste. For example, if you’re allergic or sensitive to lactose or gluten-which may be used to fill and bind pills-ask your pharmacist to verify the ingredients in the product you receive.
Manufacturing and testing standards
New brand-name drugs are subjected to more stringent testing standards. Prior to FDA approval, pharmaceutical companies must first submit reports of independent clinical trials proving the drug’s safety and efficacy. They must also provide detailed manufacturing specifications, proposed labeling, and a discussion of why the benefits of the medicine outweigh any risks.
Makers of generic drugs have an easier time. They submit what is known as an “Abbreviated New Drug Application.” They are not required to provide independent evidence of safety or efficacy. They must only show that the drug is the “pharmaceutical equivalent” (has the same active ingredients) and the “bioequivalent” (same rate and extent of absorption). They must also use the same labeling as the name-brand drug.
Different legal liability?
A manufacturer of a brand-name drug can be sued if packaging does not adequately warn consumers of the risks associated with taking the medication. However, a recent court case indicates that liability for “failure to warn” does not generally extend to pharmaceutical companies that make generic drugs. In Pliva v. Mensing, 131 S. Ct. 2567 (2011), the Court held that “… federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state claims.” Simply put, this ruling means manufactures of generic drugs cannot be sued for failure to warn because they are bound by federal law to use the same labeling as the brand-name drug and cannot unilaterally change their own packaging.
The United State Supreme Court recently heard oral arguments in Mutual Pharmaceutical Co. V. Bartlett (12-142). The drug company is attempting to have a multi-million dollar judgment set aside by arguing that a “design defect” is covered under the same federal law which prevents generic drug manufacturers from changing the product or the label. A ruling is expected this summer.
Quality Control
The New York Times reported earlier this month that generic drug maker Ranbaxy pleaded guilty to federal drug safety violations. The company admitted to manufacturing lapses at plants in India and the U.S.; selling subpar drugs; making false statements to the FDA; and other infractions. Ranbaxy has been assessed $500 million in fines, the largest in history involving generic drugs.
Whistle-blower groups worry that this may be the tip of the iceberg due to minimal federal drug safety oversight of plants outside of the U.S. On its website, the FDA indicates that it currently inspects foreign generic manufacturing plants about once in every 7 to 13 years, versus once every two years for domestic. However new legislation enacted last year will provide more funding to the FDA. The Generic Drug User Fee Amendments of 2012 (GDUFA), seeks to improve access, quality and transparency. Curiously, the act is funded in part by… you guessed it: The generic drug industry.