What are Generic Drugs?
Generic drugs are the bioequivalent of name-brand pharmaceuticals offered at a highly discounted rate. The Food and Drug Administration (FDA) requires that all generic products must contain the same active ingredients as their name-brand counterparts, though inactive ingredients may vary to some extent. Required to have the identical dosage form, route of administration, strength of dosage, use indicator, purity, and quality, generic drugs essentially differ in name alone. Generic drugs are still required to undergo approval by the FDA but are not subjected to the same functionality and safety tests.
How do Generic Drugs Come to Market?
Like any manufactured product, pharmaceutical drugs are protected by patent. Name-brand drug ingredients and manufacturing methods remain protected until their first patent expires, at which point the information can be obtained by other drug manufacturers that create the drug in a generic form.
Who uses Generic Drugs?
Nearly 8 of 10 prescriptions are filled with the generic form of a name-brand drug. This number is expected to increase as many drug patents expired in 2015-16. Offered at an 80-85% discounted rate on average, generic forms are preferred by pharmacies and insurance companies alike. Most insurance providers require patients be prescribed generic versions of a drug if the generic form exists. Even if your prescription is written for a name-brand pharmaceutical it is likely that you will receive the generic form.
The Loophole: Why Generic Drug Makers Aren’t Liable for Injuries
In a short time you will find you are saving money on your prescription medicine, but be aware that it comes at a risk – generic drug manufacturers no longer have to warn consumers of newly discovered dangers associated with their drugs. When a consumer is injured by a defective or dangerous product, generally the manufacturer is liable for any defect in that product. In terms of pharmaceuticals, these defects can occur when (1) a side effect is not included in the warning label, (2) the manufacturer advertises the drug for off-label use, (3) or the warning label is unclear. However, in a 2011 case “Pliva v Mensing,” a judicial ruling found that generic drug makers should not be held responsible for injury to consumers. The argument made to find this decision was that product liability cases brought against pharmaceutical manufacturers are tried at the state court level. State laws regarding product liability are much more stringent than federal laws, yet the FDA sets the standards for the federal laws regarding pharmaceutical manufacturing and approves the drugs for market. The generic drug manufacturers argue that federal approvals preempt state laws and they cannot be expected to meet both state and federal regulations because they do not design the drugs, they only recreate the name-brand form. In the case of “Pliva v Mensing” the judge found that the generic drug manufacturer should not be held liable because they were simply recreating an already approved-for-market pharmaceutical. While a manufacturer of a brand-name medication has a duty to warn the public of increased risks associated with the medication, whether those risks are discovered before or after the drug hits the market, generic manufacturers are required only to provide the same warnings and risk information that the brand-name manufacturer provides. In short, if a generic manufacturer learns of a risk that is not accurately or adequately described in the drug’s written warnings, the generic manufacturer has no duty to warn the public unless the brand-name manufacturer does so first.
How does this Affect You?
Where there is a gain for patients, both financially and in overall health, the gain comes at a huge cost: generic drugs are now less safe than the name-brand versions. Although generic medicines are chemically equivalent to the original brand-name drug, they are not treated the same by the FDA. Even if you receive a name-brand prescription, it is likely your insurance provider or pharmacist prefer the cheaper generic version, if one exists. In the case that you were to experience adverse effects from the generic drug, it would be very difficult to prove that the manufacturer is liable for these effects. Because you are not taking the brand-name version of the drug, the manufacturer of the original drug is also not liable for these adverse effects. If you have experienced any adverse effects from using a generic pharmaceutical, contact the office of TorHoerman Law. We can help you find the justice deserve.