FDA Requires Side Effects Statement on Labeling

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration has issued a final rule requiring the addition of a statement and toll-free number to the labeling of certain human drug products.

Rockville, MD (Nov. 6)-The US Food and Drug Administration issued a final rule requiring the addition of a statement and toll-free number to the labeling of certain human drug products. The statement must advise users that the number is to be used to report side effects and should not be used to seek medical advice.

The rule, titled Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, was issued Oct. 28, 2008, and confirms the interim final rule of the same name that was issued Jan. 3, 2008. It applies to drug products approved under section 505 of the Food, Drug, and Cosmetic Act.

This final rule also affirms the addition of the new part 209 to current regulations requiring distribution of the side-effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The new statement must appear in the medication guides of the products, and pharmacies must distribute the statement with all new and refilled prescriptions in one of the following ways:


  • On a sticker attached to the product’s package, vial or container

  • On a preprinted pharmacy prescription vial cap

  • On a separate sheet of paper

  • In consumer medication information

  • By distributing the appropriate FDA-approved Medication Guide.

FDA provided a few estimates for implementing the final rule, which will impact manufacturers, distributors, pharmacies, and regulators. The agency estimates that manufacturers will spend $3000 per shelf-keeping unit (SKU) to modify labeling of a new drug application (NDA) over-the-counter (OTC) product and $1000 per SKU for an abbreviated new drug application (ANDA) OTC product. Revision of medication guides is expected to cost between $4177 to $4500 (in 2007 dollars) for an NDA prescription drug and from $1580 to $1800 for a prescription drug with an ANDA. For private OTC drug distributors and manufacturers, FDA estimates total one-time costs ranging from $38 million to $49.6 million.

The overall estimated cost of implementing the final rule ranges from $16.9 million to $52.2 million with a 3% discount rate and from $17.8 million to $53.4 million with a 7% discount rate. Most of this cost will likely be passed on to consumers, says the rule.

The final rule takes effect Nov. 28, 2008. The compliance date is July 1, 2009. Read the complete rule here. In May, an FDA advisory panel advised that the agency require toll-free numbers on direct-to-consumer television ads for the purposes of reporting side effects, according to a Washington Postarticle. This particular issue is still pending.