On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work, including efforts to combat the opioid crisis and to further implement the 21st Century Cures Act. The Roadmap identifies four key policy areas, each with accompanying goals and actions:
- Reduce the burden of addiction crises that are threatening American families.
- Leverage innovation and competition to improve health care, broaden access, and advance public health goals.
- Empower consumers to make better and more informed decisions about their diets and health and expand the opportunities to use nutrition to reduce morbidity and mortality from disease.
- Strengthen FDA’s scientific workforce and its tools for efficient risk management.
Although the Roadmap is not particularly revelatory, it does show an increased emphasis on newer areas, such as nicotine addiction, and new approaches for digital health products. The plan does not include proposed timelines for any of the actions, many of which are likely to span multiple years.
The FDA intends to continue its multi-pronged approach to addressing the opioid crisis. This includes ongoing efforts to reduce the inappropriate prescribing of opioids and to improve drug development paths for less addictive pain medications. The Roadmap also emphasizes the need to improve treatment for current addicts, specifically by finalizing policies to make the overdose reversal drug naxolone available over the counter and by helping people gain access to medication-assisted treatment (MAT). In a move aligned with other Trump administration views on illegal drugs, the Roadmap includes plans to increase enforcement of unauthorized marketing or distribution of opioids, including illegal importation.
Nicotine & Tobacco
Moving beyond the omnipresent focus on the opioid crisis, the FDA also announced plans to reduce nicotine addiction and drive changes in tobacco use. These include developing an approach to regulating nicotine levels in combustible (traditional) cigarettes with the goal of reducing the national mortality rate of use of these products. Noting that nicotine is not directly responsible for cancer, lung disease, and heart disease, the FDA intends to foster innovation in nicotine products, including e-cigarettes. The agency plans to issue a series of rulemakings and guidance on this topic throughout the year.
Drug Pricing & Competition
Recognizing that there is room for improvement in drug pricing and access, the FDA plans to release multiple draft and final guidance documents to drive competition and streamline requirements for drugmakers. These include:
- Draft guidance on the process for granting waivers for the shared-system risk evaluation and mitigation strategy (REMS) requirement for generic drugmakers. These firms are currently required to adopt a REMS with branded drugmakers to help ensure that the benefits of products outweigh the risks. The FDA hopes that changes to this waiver process will reduce the administrative burden on generic firms — and thus drive competition.
- Final guidance on how drug developers share information about the economic consequences of their products to payers, which the FDA hopes will promote value-based contracting.
- Draft guidance on more efficient processes for handling citizen petitions, also known as 505(q) or “blocking” petitions, which allow individuals or organizations to formally request that the FDA take action on a specific topic. The Roadmap notes that these petitions have rarely delayed the generic drug approval process but can be a burden on FDA review resources.
The agency also announced the upcoming launch of a Biosimilar Innovation Plan that aims to create incentives for the development of these relatively new products, eight of which have been approved to date.
Consumer & Digital Health
Reflecting the increase in readily available health information from products such as wearables and at-home genetic tests, the FDA intends to take a number of steps to increase Americans’ access to reliable health data. On the digital health front, this includes publishing final guidance on the kinds of digital health technologies that do or do not fall within the FDA’s scope of reviews and continuing the Pre-Cert pilot program for the voluntary review of digital health software. The agency will also consider possible approaches for programs for the review of health and genomic diagnostic tests. The FDA aims to make sure Americans have ready access to clear nutrition data through guidance on menu labeling and a public education campaign regarding how to use this information.
In 2018, the FDA plans to continue its ongoing efforts to strengthen its workforce by streamlining hiring practices and leveraging hiring and pay authorities, including those granted by 21st Century Cures. The agency also intends to ramp up its use of technology to create efficiencies in its review process. Technologies referenced in the Roadmap include supercomputing clusters and modeling techniques to support drug development.