Source: http://www.fdalawblog.net/2012/02/fda-flexes-new-enforcement-muscle-issues-warning-letter-for-failure-to-meet-required-postmarketing-s/
Timestamp: 2019-04-23 02:50:20+00:00

Document:
Among the Warning Letters FDA posted on its website this week, one in particular caught our attention – a February 17, 2012 Warning Letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violatation of FDC Act § 505(o)(3). FDA’s enforcement action against Merck appears to be the first of its kind citing the new authority Congress granted FDA under the FDA Amendments Act of 2007 (“FDAAA”).
FDC Act § 505(o)(3) states that FDA may “require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs.” A PMR is intended to “assess a known serious risk related to the use of the drug involved,” “assess signals of serious risk related to the use of the drug,” and “identify an unexpected serious risk when available data indicates the potential for a serious risk.” FDC Act § 505(o)(3)(E)(ii) requires sponsors to periodically report to FDA on the status of a PMR. A violation of FDC Act § 505(o) is a basis for misbranding under FDC Act § 502(z), and may result in civil monetary penalties under FDC Act § 303(f)(4) of $250,000 per violation, with the potential for significant additional penalties for a continuing violation. In April 2011, FDA issued guidance on the Agency’s implementation of FDC Act § 505(o)(3).
Under section 502(z) of the Act [21 U.S.C. 352(z)], your product is considered misbranded because you are in violation of a [PMR] established under section 505(o)(3) of the Act. You have failed to comply with the approved timetable and periodic report submissions of section 505(o)(3)(E)(ii) of the Act and failed to show good cause for not conducting the additional testing required to further assess whether a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with the use of sitagliptin, represents a public health risk.
Failure to promptly correct this violation may result in regulatory actions by the FDA without further notice. These actions include, but are not limited to, civil money penalties. Other federal agencies may take this Warning Letter into account when considering the award of contracts. In addition, civil money penalties under section 303(f)(4) of the Act [21 U.S.C. 333(f)(4)] could be levied for a maximum of $250,000 per violation, with the possibility of additional penalties if the violation continues uncorrected.

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