Adverse Event Hotline On Rx Bottles Gets Final Rule; No Enforcement Till 2009

As mandated by the FDA Amendments Act, a rule that requires Rx packaging to contain a toll-free number for reporting adverse events is now in effect, but FDA said it will not likely enforce it until 2009.

The pause will give the agency more time to study how the statement should appear as well as give companies time to come into compliance with the new reg.

FDA issued an ¹ interim final rule on Jan. 3. Under FDAAA, FDA's proposed rule from 2004 became effective on Jan. 1, since FDA had not yet issued a final rule. The only changes from the proposed rule involve the mandate in FDAAA to exclude OTC products which already contain a number, but FDA could make further revisions to the interim rule.

FDA was in the process of analyzing comments and conducting an Internet "labeling comprehension experiment" to determine consumer comprehension of nine potential statements when FDAAA was passed in September (² (Also see "Side Effects? FDA May Require Adverse Event Hotline Even As Surveys Continue" - Pink Sheet, 15 Oct, 2007.), p. 11).

"FDA determined that the research ... to inform the proposed side effects statement could not be completed in time," the interim rule states, "and that this research needed to be completed for the agency to respond fully to the comments" it received in response to it 2004 proposed rule.

It's Time To Study, Not Time To Enforce

FDA told "The Pink Sheet" that the agency hopes to have the Internet experiment results by late February or early March.

Based on the results of the data collected, the agency "will determine whether to finalize this interim final rule as published or to publish a final rule that amends this interim final rule."

Since FDAAA did not address time for compliance, FDA proposed that all "affected entities" be in compliance not more than 1 year after the effective date of the final rule.

"FDA continues to anticipate that affected entities ... will need time to update labeling and systems to comply with the new requirements. Therefore ... the agency intends to exercise its enforcement discretion with regard to these regulations until Jan. 1, 2009."

If an amended final rule is published in the future, it will be designed to minimize the burden of any additional changes on the affected entities, FDA states.

FDA and industry have long been concerned that encouraging patients to call the agency with safety concerns could rob firms of valuable information about their products while burdening FDA with a resource-intensive reporting system of unproven utility (³ (Also see "PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms" - Pink Sheet, 16 Apr, 2007.), p. 14).

However, Congress has over the years pressed the agency to move forward with the program. The 2004 proposed rule for the "side effects statement" was generated in response to instructions in the 2001 Best Pharmaceuticals for Children Act, and apparent dissatisfaction with the pace of FDA's progress lead to requirement of an effective date being include in the 2007 FDAAA legislation.

Many Paths To Compliance

The specific requirements of the new labeling reg place considerable responsibility on pharmacists in many cases. Under the interim rule, the format, content and dispensing requirements include:

The side effects statement must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."

If the side effect statement will be distributed on a sticker or preprinted vial cap, the letter height or type size must be greater than or equal to 6 points (1 point = 0.0138 inch). If distributed by separate sheet of paper, consumer information, or medication guide, the size goes up to 10 points.

The side effects statement must be distributed with each new and refill prescription. The authorized dispenser can choose the method of distribution, but must adhere to the format specifications.

- Becky Jungbauer ([email protected])