FDA Stakeholder Update - Friday February 15, 2019

Dear Colleague,

FDA’s Strategic Policy Roadmap, identified four priority areas that help further our commitment to advance public health and over the past few weeks, FDA has had some notable news and statements that are important to highlight. The four key priority areas are:

1. Reduce the burden of addiction crises that are threatening American families
2. Leverage innovation and competition to improve health care, broaden access, and advance public health goals
3. 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
4. Strengthen FDA’s scientific workforce and its tools for efficient risk management

Key Priority #1: Reduce the burden of addiction crises that are threatening American families

• Ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic As FDA continues to take a range of steps to forcefully confront the opioid crisis plaguing our country, most people think first and foremost about the agency’s work to encourage more appropriate prescribing to decrease exposure to opioids and prevent new addiction, as well as our initiatives to advance innovations in both novel pain therapies and better treatments to help those with opioid use disorder. Our efforts to combat this public health emergency, however, extend also to stopping the spread of illicit opioids and further securing all aspects of the supply chain for legitimate medications, including opioids. (02/12/19)
• New data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use The Centers for Disease Control and Prevention (CDC) released additional data from our joint FDA/CDC 2018 National Youth Tobacco Survey. These data are a sobering reminder of the initial results we shared last fallindicating a rampant rise of youth e-cigarette use, which has prompted the FDA to take a series of escalating regulatory actions as part of our Youth Tobacco Prevention Plan. (02/11/19)
• Vaping and e-Cigarettes in Kids- An Unprecedented Epidemic: A Medscape Interview With US Surgeon General Jerome Adams and FDA Commissioner Scott Gottlieb. (01/28/19)

Key Priority #2: Leverage innovation and competition to improve health care, broaden access, and advance public health goals

• New programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs The overall goal of this program is to promote development and appropriate use of consensus standards to help expedite pharmaceutical development and streamline the review of drug product applications. By providing a list of recognized standards on our website, we will provide transparency regarding our thinking on a particular standard, which will help industry compile information for applications, can streamline the FDA’s assessment and allow us to focus our efforts on developing guidance on other quality topics. (2/13/19)
• New steps to strengthen the agency’s process for issuing public warnings and notifications of recalls FDA issues final guidance that outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general time-frame for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. (02/07/19)
• FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines The agency is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain. (02/07/19)
• 2019 efforts to advance the development of complex generics to improve patient access to medicines In 2019, FDA will advance additional policies to promote generic competition for complex drugs. Among other steps, we intend to issue additional guidance documents for developing specific complex generic drugs, as well as address categories of complex drugs that are hard to copy because of their complex formulation or mode of delivery. (01/30/19)

Key Priority #3: 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

• The agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight FDA announced new steps we intend to advance to achieve these goals. These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders. (02/11/19)

 

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