FDA 2018 Goals

Some of the FDA’s Major Policy Goals for 2018 To start off the New Year we’re going look at some of the FDA’s major policy goals for 2018. By way of background, twice a year the federal government publishes the "Unified Agenda of Federal Regulatory and Deregulatory Actions" (Unified Agenda), which provides the public insight into regulations under development or review throughout the federal government. According to Scott Gottlieb, M.D., the current FDA Commissioner, “For the U.S. Food and Drug Administration, it [the Unified Agenda] provides an opportunity to outline some efforts to modernize our approach to our work and improve our efficiency, while fulfilling our mandate to protect and promote the public health and uphold FDA's gold standard for regulatory decision-making. While many of FDA's polices are advanced through guidance documents and other proposals, this annual list of proposed regulations provides one element of our policy agenda.”¹ The following are a few of the FDA’s major policy goals and key priorities for 2018. To get more complete information on all of the FDA’s 2018 goals, go to www.fda.gov.

• Addressing the nicotine addiction crisis. To reduce the morbidity and mortality associated with smoking tobacco products, the FDA is proposing meaningful actions to advance their new, comprehensive approach to nicotine and the regulation of cigarettes. These efforts include the FDA issuing an Advance Notice of Proposed Rulemaking that asks critical questions related to the issuance of new regulations that would result in a targeted reduction of the nicotine levels in cigarettes to eliminate or dramatically reduce their addictive value.
• Advancing drug safety. During 2018 the FDA will issue several regulations on drug compounding to help ensure the quality and safety of medicines that patients need and depend on. The goal is to ensure that outsourcing facilities clearly understand which drugs they may compound and allow those firms to adopt more efficient, streamlined manufacturing standards, while still ensuring that they observe all necessary safety and quality measures.
  • When it comes to the safety of prescription drugs, the FDA is also looking at a issuing a rule to establish national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers, as part of the FDA’s current ‘track-and-trace’ requirements. By establishing national standards for all State and Federal licenses issued to key parts of the supply chain, these regulations will allow for the safe, effective and efficient distribution of prescription drugs throughout the U.S.
• Promoting food safety
• Empowering consumers with information
• Providing better information on drugs. The FDA has also included a rulemaking that proposes a new type of patient medication document that would help ensure that patients have access to clear, concise, and useful written information about their prescription drugs or biologics, delivered in a consistent and easily understood format, each time they receive a medication from the pharmacy. The FDA’s goal is to give patients the ability to make high value decisions about the medicines they take, and help them use drugs safely and effectively.
• Broadening access to non-prescription drugs. The FDA is looking into innovative actions in the non-prescription drug area to expand the scope of drug products that can be made available to consumers without a prescription. In 2018 the FDA will be proposing several new, innovative approaches for manufacturers to use to demonstrate that a prescription drug product can be used safely and effectively in a non-prescription setting.

“We hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health. We are committed to advancing this new framework to enable a potentially broader selection of nonprescription products for consumers, empowering them to self-treat more common conditions and chronic conditions. This also could help lower costs by increasing the availability of products that would otherwise be available only by prescription.”²

• Modernizing standards
• Harmonizing global standards
• Modernizing mammography standards
• Embracing electronic submissions
• Removing outdated rules

 “Many of our agenda submissions are part of a broader effort to empower consumers and patients to make more informed and effective health decisions and ensure they have appropriate autonomy over their choices, while continuing to ensure the products they consume and use are safe and effective. Over the next year, we will also tackle many additional priority areas through guidance documents and other policy efforts. These areas will include efforts to reduce the cost of drugs by encouraging competition, spur innovation across medical products, give consumers access to clear and consistent nutrition information, create greater regulatory efficiencies in bringing products to market, and put a dent in the opioid addiction crisis facing our country.”³     1. Blog entry from Scott Gottlieb, M.D. 2. Op. cit. 3. Op. cit.