FDA Outlines Policy Priorities for 2018By
The US Food and Drug Administration (FDA) has announced its 2018 Strategic Policy Roadmap, which highlights the agency’s priorities. Key items on the agency’s agenda are policies for: addressing the opioid addition crisis; leveraging innovation and competition to improve healthcare, broaden access, and advance public health goals, including improving the generic-drug review process; enabling consumers to make better and more informed decisions about their diets and health, including through the use of digital health technology; and strengthening FDA’s scientific workforce and its tools for efficient risk management.
“Our Roadmap is not intended to be a traditional strategic plan; and it is not an exhaustive list of the important policies that FDA will initiate and pursue over the coming year,” said FDA Scott Gottlieb in an agency statement. “In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next two years. Publishing this Roadmap is another way that we aim to provide more transparency about the FDA’s policy undertakings to all our stakeholders.”
The FDA said that the opioid addiction crisis is principal among public health challenges. “We need to take steps to reduce exposure to opioid drugs by helping to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription,” said the FDA in its 2018 Strategic Policy Roadmap.
To further address the crisis, the agency said t it plans to do the following: (1) assist in the conversion of the market toward wider use of opioid drugs with improved formulations that are harder to manipulate and abuse; (2) advance the development of drugs and devices that can treat pain and are less likely to lead to addiction; and (3) create new paths for the development and approval of better treatments for addiction.
FDA also outlined its plans to promote generic drug competition to reduce patient costs. “Among other steps, we will be issuing new draft guidance in the first quarter of 2018 on FDA’s process for determining whether to grant a waiver of the requirement for generic firms to adopt a single, shared-system REMS [Risk Evaluation and Mitigation Strategy] system with branded drug makers,” the FDA said in its policy roadmap. “We will also advance draft guidance on the development of shared-system REMS, to make the process for developing a shared REMS more efficient.”
The FDA also said it would issue new guidance on how it intends to more efficiently handle citizen petitions, including “blocking” petitions that are subject to section 505(q) of the Federal Food, Drug, and Cosmetic (FD&C) Act, which governs petitions requesting that the FDA take any form of action related to a pending application submitted under section 505(b)(2) or 505(j) of the FD&C Act. The agency says it is sometimes argued that these petitions block entries of generic drugs.
In January 2018, the agency denied three such citizen petitions from Novo Nordisk, Allergan, and Amneal Pharmaceuticals, a Paterson, New Jersey-based generic-drug manufacturer. “While the record shows that citizen petitions have rarely delayed specific generic drug approvals, there is no doubt that the deadlines associated with 505(q) petitions can add to resource burdens on the generic-drug review process,” the FDA said in its policy roadmap. “We expect our new guidance will allow for a more efficient approach to 505(q) petitions, and allow us to focus more reviewer resources on the approval of generic drugs.”
The agency also plans to take new steps to make the process for developing and approving biosimilar drugs more efficient. “As part of these efforts, we will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs. These policies will be part of a new Biosimilar Innovation Plan (BIP) that we will advance over the coming year,” the agency said.
The roadmap also included new steps to prioritize digital health technology. The FDA says it plans to adapt its traditional approaches to regulation to better fit the challenges presented by new areas of technology. The agency says its Pre-Certification Pilot Program, part of the implementation of its Digital Health Innovation Action Plan, is one such effort.