Congress Requires Action on FDA’s Proposed Toll-Free Number Adverse Event Reporting Labeling Rule

October 19, 2007

Buried in Title V of the recently-enacted FDA Amendments Act ("FDAAA") is a provision requiring FDA, with certain limitations, to either publish final regulations to provide for the addition of a toll-free number to product labeling to report adverse events, or to make the Agency’s proposed regulations effective beginning on January 1, 2008.

When the Best Pharmaceuticals for Children Act ("BPCA") was enacted in January 2002, Congress required FDA to promulgate regulations to add to product labeling a toll-free number to report adverse events.  Specifically, BPCA § 17(a) states:

Not later than [January 4, 2003, FDA] shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under [FDC Act § 505] (regardless of the date on which approved) include the toll-free number maintained by [FDA] for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule: 

(1) The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience. 

(2) In promulgating the rule, [FDA] shall seek to minimize the cost of the rule on the pharmacy profession. 

(3) The rule shall take effect not later than 60 days after the date on which the rule is promulgated.

On April 22, 2004, FDA published proposed regulations in the Federal Register.  In the preamble to FDA’s proposed regulations, the Agency explained that:

the MedWatch system should be used to fulfill the requirements of the BPCA for providing a toll-free number for the purpose of receiving adverse event reports regarding drug products.  FDA is proposing that the side effects statement be distributed with each prescription drug product, both new prescriptions and refills, approved under [FDC Act § 505] and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting. FDA is proposing a number of options/alternatives to meet this proposed requirement.  FDA also is proposing to require the side effects statement in two categories of drug product labeling: (1) FDA-approved Medication Guides for drugs approved under [FDC Act § 505], and (2) the labeling for OTC drug products approved under [FDC Act § 505].

Although FDA received relatively few comments on the proposed rule, the Agency has not yet published final regulations.  According to an October 11, 2007 Federal Register notice and Supporting Statement submitted by FDA, "[a]fter the publication of the proposed rule and based on the comments received, it was decided to delay the issuance of the final rule in order to conduct research to study the wording of the proposed side effects statements."

Apparently frustrated with FDA’s failure to make sufficient progress to issue final regulations, Congress included the following provisions in FDAAA § 502(f) (Title V reauthorizes the BPCA through Fiscal Year 2012):

(1) IN GENERAL- Notwithstanding [the Administrative Procedure Act] and any other provision of law, [FDA’s April 22, 2004 proposed rule] shall take effect on January 1, 2008, unless [FDA] issues the final rule before such date.

(2) LIMITATION- The proposed [or final] rule that takes effect under [BPCA § 17(a) (2002)] shall, notwithstanding [BPCA § 17(a) (2002)], not apply to a drug —

(A) for which an application is approved under [FDC Act § 505];

(B) that is not described under [FDC Act § 503(b)(1)]; and

(C) the packaging of which includes a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug.

FDAAA § 502(f)(2) therefore limits the application of FDA’s proposed regulations (if they go into effect in January 2008) or any final regulations issued before January 1, 2008 to exclude OTC drugs approved under a marketing application if certain labeling requirements are met.  The limitation to prescription drugs is presumably intended to clarify Congress’ original intent in BPCA § 17(a).  Indeed, at least one comment submitted in response to FDA’s April 2004 proposed rule noted that OTC drugs were not the intended target of BPCA § 17(a).

It is unclear at this time whether FDA will be able to meet the January 1, 2008 deadline when the Agency’s proposed regulations are scheduled to go into effect.  Given FDA’s recent activity as noted in the Federal Register, however, the Agency appears to be moving ahead with its plans to finalize the proposed rule. 

Categories: Drug Development