Industry Concerned About Proposed Drug Label Changes in Australia

Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and for labels to be made and applied so that they cannot be damaged by opening a product.

The changes would require drugmakers to make major modifications to label design, packaging configurations and packaging processes, all of which are unreasonable costs to place on the industry, Medicines Australia says.

The input comes in response to an August 2014 solicitation by the Therapeutic Goods Administration for comments on proposed revisions to the general labeling requirements for drugs.

The central change in the proposal calls for a text size of at least 15-point Arial type on the front of a product package to display the active ingredient name and quantity or proportion, much larger than the current requirement of 1.5 millimeters (roughly 5 points), Bayer says. The company says meeting the new requirement for some label sizes can only be achieved by reducing or removing information such as the drug’s uses.

GlaxoSmithKline says it would need to purchase new equipment to produce labels for some packages, or apply for exemptions to the rule.

Further, Novartis argues that increasing the prominence of the active ingredient name on a label would do little to accomplish the goal of the proposed revision, which is to diminish the risk of misuse or overdose.

A second area of concern in the proposal, which attracted 80 comments overall, is that labels would have to be made so durable that they cannot be damaged by opening the product. GSK says it can put features on labels to make it clear if they have been damaged, but it can’t control the way a consumer opens a package.

GSK also urges the TGA to issue separate requirements for prescription and nonprescription drugs, since doctors can instruct patients when prescribing a medication, while patients using OTC drugs may need to be more involved in understanding how the medication is to be taken.

The Australian Self Medication Industry also supports separate rules for prescription and OTC drugs and says labeling requirements should be vary according to the risk a drug poses.

View all of the comments at http://www.fdanews.com/01-15-TGA-Comments.pdf. — Jonathon Shacat