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DRUG MANUFACTURERS MUST IDENTIFY RISKS ON THE LABEL

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By: Carol J. Gibbons, J.D.

Hooray for Congress! Today President Bush signed into law The Prescription Drug User Fee Reauthorization Act (PDUFA), H.R. 3580. According to the American Association for Justice, the Congress passed a new law that creates new federal safety requirements for drug companies, and Congress was very clear that the bill does not change the burden on the drug companies to warn of a drug’s hazards.

Drug companies know more than anyone what the potential risks are of taking their medications. Why don’t they want to inform us of those risks on the label so we will know too? Are they afraid if we make informed decisions that we may not use a particular drug and their sales are negatively affected? We have a right to know the possible side-effects and risks to any medication we put in our bodies! This new law makes it a requirement that all drug manufacturers modify labels as new risk information is known, regardless of whether they have been mandated by the FDA.

When your doctor prescribes a certain medication for you, don’t you want to know the benefits AND the risks of taking the medication? While doctors ethically should warn patients about possible risks and side effects of prescribed medicine, often they don’t know them. And, the reason they don’t is because the drug manufacturers do not disclose them to doctors any more accurately or often then they do to the general public. This law requires accurate and up to date disclosure of drug side effects.

Medications have benefits and risks. Take penicillin for example. Penicillin is a very effective antibiotic and has saved countless lives. However, many people have an allergic reaction to penicillin that could be fatal. Using penicillin is a balancing act; do the potential benefits outweigh the risks?

In order for us to make an informed decision regarding the risk and benefit analysis of using any drug we need full disclosure of the risk information. That is what this law does without eroding your rights to hold negligent or deceitful drug companies accountable, which is what the drug company lobbyists put a lot of effort into accomplishing as additional terms in this new law.

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