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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019. As expected, parts of CDER were affected by the government shutdown, which has caused a delay in the development of some of the Center’s policy activities and accomplishments to start the year. However, despite the delay, Dr. Woodcock provided updates on several initiatives coming up in 2019. Below is a summary of the major initiatives to expect in 2019. Overall, it looks like CDER is gearing up for a busy and productive year. Industry stakeholders should be on the lookout for many new developments coming out of the Center.

  • New Drug/Biologic Regulatory Program Modernization: New drug and biologic license applicants will begin to see a lot of changes in 2019 as CDER begins to implement its new review process for NDAs and BLAs. In the coming year, CDER plans to reorganize the office with multiple changes within the Office of New Drugs.
  • Drug Shortages: CDER has recently held a series of public meetings to address the issue or drug shortages and how to deal with them in the long run. Currently, CDER is requesting that manufacturers provide the Center early notification of shortages.
  • Compounding: CDER will continue to make pharmacy compounding a high priority. CDER’s inspection of outsourcing facilities will likely continue going forward. CDER is also working on a regulatory framework for working with states on traditional pharmacy compounding and how it plans to regulate 503B outsourcing facilities. The Center further plans to continue issuing guidance documents and hosting meetings to address outstanding compounding issues. It also is working with outside organizations, such as the National Academy of Medicine, on specific compounding issues.
  • OTC Monograph User Fee Program: FDA is very interested in reforming the OTC monograph process. As noted by Dr. Woodcock, there are significant limitations to the existing monograph process. OTC drug manufacturers should continue to monitor the pending legislation and can read more about the proposed legislation in our LawFlash.  
  • Opioid Crisis: FDA will continue to expand its efforts in addressing the opioid crisis, including encouraging the development of new modalities to both treat opioid-use disorders as well as alternative analgesics. In 2019, the Center will begin implementing some of the provisions and authorities it was given in 2018 pursuant to the SUPPORT Act (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act), which was signed into law in October. Manufacturers should be on the lookout for additional guidance from FDA on how it plans to implement its authority.