From CDER's email news of today: FDA provides Q&A on the Federal Register Notice on Drugs and Biological Products Deemed to Have A Risk Evaluation and Mitigation Strategy ("REMS"). (1) [re: 3/27/08 Federal Register Notice see (2)] FDA is:
identifying drugs and biological products approved/licensed before the provisions of FDAAA that are deemed to have REMS...sponsors of these drug and biological products must submit a proposed REMS by [9/21/08]. This is the first notice FDA has issued under the new drug safety authorities in FDAAA.
REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS.
Elements to assure safe use include: --Health care providers who prescribe the drug have particular training or experience, or are specially certified; --pharmacies, practitioners, or health care settings that dispense the drug are specially certified; --the drug is dispensed to patients only in certain health care settings, such as hospitals; --the drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results; --each patient using the drug is subject to certain monitoring; or --each patient using the drug is enrolled in a registry (see section 505-1(f)(3) of the Act).
During the approval process, FDA will determine whether a REMS is required to ensure that the benefits of the drug or biological product outweigh the risks. If so, FDA will require the sponsor of the application to submit a proposed REMS and the REMS will be approved when the drug or biological product is approved/licensed. If a product is already approved/licensed and FDA becomes aware of new safety information that suggests a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks, it will require a REMS.
New safety information is: Information derived from a clinical trial, an adverse event report, a postapproval study, or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system…or other scientific data deemed appropriate by the Secretary about a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing information) since the drug was approved, since the REMS was required, or since the last assessment of the approved REMS; or the effectiveness of the approved REMS obtained since the last assessment of the strategy.' (See 505-1(b)(3) of the Act).
FDA "next steps" include an interim Guidance for industry that will describe the content and format of a proposed REMS.
(1) http://www.fda.gov/cder/regulatory/FDAAA/default.htm
(2) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
(3) http://www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm
(see below for their excerpt on FDA’s enforcement authority under this FDAAA provision)
FDA may impose civil monetary penalties for violations of the REMS provisions or the drug or biological product can be deemed misbranded, and FDA could obtain injunctive relief. FDAAA state that the penalties may not exceed $250 thousand per violation, or $1 million for all violations adjudicated in a single proceeding. If a violation continues after the sponsor receives written notice, the penalty is $250 thousand for the first 30-day period (or any portion thereof) that the violation continues, not to exceed $1 million for any 30-day period, and not to exceed $10 million for all violations adjudicated in a single proceeding. FDA may take into consideration whether the company is making efforts to correct the violation when determining the amount of a civil penalty.