Final standards for evaluating a major statement are not yet published.

Under FDAAA, FDA also has the authority to require a company to disclose a drug’s approval date for up to 2 years after a drug is approved if it “determines that [an] advertisement would otherwise be false or misleading”.13 FDA has declined to require an indication that a drug is new out of concern that “new” will be wrongly interpreted by consumers to imply “new and improved” (FDA, 2009a).


Before the passage of FDAAA, FDA could not require a drug manufacturer to change a label even if FDA became aware of new safety information about a marketed drug. FDA negotiated with the manufacturer about the language of the label, and its recourse was to use a claim of “misbranding” to revoke, or threaten to revoke, approval if a company was not willing to change a drug’s label (Carpenter, 2010). Under FDAAA, FDA can require changes in the label of a drug to reflect new information about its benefit–risk profile. Those changes can include “boxed warnings, contraindications, warnings, precautions, or adverse reactions”.14


In addition to increasing FDA’s postmarketing responsibility and authority, FDAAA specifies that user fees will be “dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarketing drug safety activities”.15 Much of the funding comes from a specific authorization of $225 million over 5 years for “drug safety”.16 The funds are being used by the Center for Drug Evaluation and Review (CDER) and others in FDA to increase the number of staff dedicated to the safety evaluation of marketed medications and to administer CDER’s new safety-related authority under FDAAA, including the implementation of REMSs, postmarketing requirements (PMRs), safety-related labeling changes, and active postmarketing risk identification (such as Sentinel) (FDA, 2009b).


FDAAA requires FDA to improve the availability and transparency of information about the drug-approval process, approved drugs, and, in particular, drug


1321 USC § 353b(e) (2010).

1421 USC § 355(o)(4)(B) (2010).

1521 USC § 379g note (2010).

1621 USC § 379h(b)(4)(B) (2010).

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