FDA proposal could change generic drug labels

10th July 2013 - Fine Cut

Current legislation that forbids the manufacturers of generic drugs from updating a product's safety label quickly could be set to change, as a result of a recent proposal from the Food and Drug Administration (FDA).

Medical companies could soon require faster access to label-making tools if officials give the plans - allowing producers to make safety information publicly available - the green light.

It comes after watchdog body Public Citizen requested a change in regulations regarding the categorisation of generic drugs almost two years ago. However, it was not until last week (July 3rd) when it emerged the organisation's pleas had been acknowledged.

As part of the proposals, the FDA is aiming to fill a "regulatory gap" that poses a risk to the safety of patients. Campaigners have previously claimed the current rules leave members of the public unaware of potential health risks from the generic drugs they take.

A separate report published by Public Citizen last month revealed after reviewing a period between January 2008 to March 2013, it was discovered that 53 drugs required a "black-box warning calling attention to serious or life-threatening risks". 

Scientists said the findings had highlighted potentially serious safety hazards connected to some medications, which may not be discovered until they had been available to customers for several years.

The researchers concluded that the amount of time a drug has been on the market may not necessarily correlate to its safety.

Dr Sidney Wolfe, founder of the Public Citizen's Health Research Group, said: "When finalised, the revisions will fill a regulatory gap that poses a risk to patient safety.

"The proposed rule is a classic example of harm reduction. When finalised after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

If passed, the new rules could have a significant impact on the generic drugs market, with almost eight in ten US prescriptions containing this type of medication.

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