The Complete Pharm Exec Guide to PDUFA - Pharmaceutical Executive

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The Complete Pharm Exec Guide to PDUFA
What Congress's grand plans for the "revitalization' of FDA really mean...besides more red tape


Pharmaceutical Executive


As in the past, the bills would largely adopt a prenegotiated user-fee framework in which industry funding pays for product-review activities (not to be confused with approvals!). In turn, FDA has once again committed to specific performance goals relating to the efficiency, speed, and quality of the review process. While PDUFA III limited use of user-fee money for drug risk-management activities to three years following approval, that limitation has been removed, permitting use of user-fee money to address postmarket safety without a time constraint.

PDUFA IV would also establish a new system for FDA review of direct-to-consumer (DTC) TV ads. This program would be voluntary, with companies funding its operations as well as paying a review fee. Such fees would not be trivial—the 2008 limit would be $83,000. However, participants will greatly reduce the likelihood of encountering a later FDA objection to an extremely expensive DTC campaign.

The Senate bill would also require FDA to provide annual PDUFA reports to Congress and to consult with a wide range of stakeholders in the development of PDUFA V. Due to controversy over the number of FDA meetings with industry relative to patient groups in PDUFA IV negotiations, the House bill would further require FDA to make the content of all such meetings available on the fda.gov/ Web site.

2 Medical Devices

The first reauthorization of medical-device user fees, initially adopted in 2002, is also part of both bills. In addition to a fee hike, the legislation would revise the current device-facility inspection program—a voluntary program intended to assist companies in harmonizing global inspections and to allow FDA to prioritize its resources—to expand participation. The current law has largely been neglected as unworkable.

3 REMS in Drug Reviews

The centerpiece of the FDA "revitalization" legislation is, as previously stated, provisions for new FDA funding and oversight of drug safety and risk minimization. The core of the drug safety provisions—a new statutory framework for integrating a Risk Evaluation and Mitigation Strategy, or REMS, into drug applications—is actually an evolution from PDUFA III, which provided funding for FDA risk-management guidance and review of voluntary risk-management plans. Many of the risk-minimization tools provided in the legislation are already in use as part of drug approvals (or for bringing risky drugs back to market), as a result of negotiations between the FDA and drug sponsors. The difference post–PDUFA IV will be that FDA will have explicit authority to seek significant limits on the systemic distribution and use of drugs—and to pursue enforcement against companies that fail to adhere to such requirements.

Both bills would authorize FDA to require that drug sponsors submit a proposed REMS for certain applications. In the House bill, a REMS proposal may be required for new drug applications, abbreviated new drug applications, biologic license applications, and major supplements if FDA "determines such a strategy is necessary to ensure that the benefits of the drug involved outweigh the risks of the drug." The Senate bill provides that an applicant may voluntarily include a proposed REMS "if there is a signal of a serious risk with a drug" and that FDA may require one "if [it] is necessary to assess or mitigate [the signal of a serious risk]." There are a number of differences in how each bill defines REMS. Proposed requirements range from core elements, such as labeling, to monitoring, registries, restrictions on distribution and use, training and certification requirements, preview of certain advertisements, and postapproval research.


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