Janet Woodcock

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It’s an ongoing intellectual challenge. It’s the intersection of science and medicine and law and policy.

— Janet Woodcock, 2018 [6]

Woodcock informs Congress and other government bodies about the FDA and its concerns in order to guide policy recommendations and legislation. [8] She has testified before congress on at least 50 occasions, under six different U. S. presidents. [6] [15] [16] She has been praised for her directness. [8]

“Again, I want it known that I appreciate Dr. Woodcock’s candor,” intoned Mr. Dingell, whose committee has jurisdiction over the FDA. “To her credit, she has stepped forth in the midst of a public health crisis to deal honestly with Congress. How I wish others in the administration showed the same vigor, responsiveness, and leadership.”

— Representative John Dingell (D-Mich.), 2008 [8]

Pharmaceutical Quality for the 21st Century

In 2000 Woodcock introduced the concept of risk management to the FDA's analysis of drug safety. [5] In 2002, she led the Pharmaceutical Quality for the 21st Century Initiative using a risk based approach to modernize pharmaceutical manufacturing and regulation. [17] [18] [7] [19]

Critical Path Initiative

Beginning with the publication of Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products (2004) [20] she has led the US Food and Drug Administration's Critical Path Initiative [5] [3] in an attempt to improve "development processes, the quality of evidence generated during development, and the outcomes of clinical use of these products." [21] Through public-private partnerships and the creation of consortia, the initiative seeks to apply advances in genomics, advanced imaging, and other technologies to the process of modern drug development. [21] [22] The goal is to more rapidly develop new medical discoveries in the laboratory and make them available to patients in need. [23] [5] [24]

Safe Use and Safety First

Woodcock has also worked to improve the quality, effectiveness and safety of drugs through the Safe Use and Safety First initiatives, introduced in 2007–2008. Drug safety is viewed from a life-cycle perspective, examining each stage of the product life cycle. [25] [3] [4]

FDA Adverse Event Reporting System (FAERS)

In 2012, the FDA rolled out the FDA Adverse Event Reporting System (FAERS), replacing the earlier AERS system. FAERS is an online database that is used by the FDA for safety surveillance of all approved drugs and therapeutic biologic products. FAERS helps to track adverse event and medication error reports from health care professionals (physicians, pharmacists, nurses and others) and consumers (patients, family members, lawyers and others). It is used in combination with MedWatch and the Vaccine Adverse Event Reporting System (VAERS) is to identify potential safety concerns. [26] [4]

Sentinel Initiative

Another monitoring system, the Sentinel System, became fully operational in 2016. Woodcock launched the Sentinel Initiative in 2008 in response to passage of the Food and Drug Administration Amendments Act of 2007 ("FDAAA"). The first Annual Sentinel Initiative Public Workshop was held in 2009, with subsequent yearly workshops to bring together possible stakeholders and explore a broad range of perspectives and issues. In 2009, the pilot program Mini‐Sentinel was launched. In 2014, expansion to a full system began. [3] [27] [28] The Sentinel System draws on existing databases of private health care insurers and providers to actively monitor for safety issues as they are developing, rather than relying on later third-hand reports. Woodcock has stated that the approach could “revolutionize” product safety. [29] [30]

Generic drug programs

In 2012 Woodcock oversaw a major reorganization of the generic drug program. [5] The first generic drug user fee program, Generic Drug User Fee Amendments of 2012 (GDUFA), was signed into law on July 9, 2012. [31] GDUFA was designed to build upon the 20-year-old Prescription Drug User Fee Act (PDUFA) and improve the generic drug review and approval process. [32] [3] [27]

21st Century Cures Act

Woodcock has also supported the 21st Century Cures Act. [33] [34]

Controversy

Opioid crisis

On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA. The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history." [35] Examples of improper opioid decisions mentioned in the letter include "approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years old." [35]

Awards

The following are among the awards received by Woodcock:

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References

  1. ↑ Javers, Eamon (Mar 31, 2010). "Drug firm investigated FDA officials". Pittsburgh Post-Gazette. Retrieved 6 March 2019.
  2. ↑ "FDA Alumni Association". U.S. Food and Drug Administration AlumnI Association. June 2, 2022.
  3. 1 2 3 4 5 6 7 8 9 10 11 12 "Janet Woodcock". The National Academies of Sciences, Engineering and Medicine. Archived from the original on 6 March 2019. Retrieved 5 March 2019.
  4. 1 2 3 4 "FDA's Janet Woodcock, MD, Receives Lifetime Achievement Award From the Institute for Safe Medication Practices". The ASCO Post. January 25, 2015. Retrieved 5 March 2019.
  5. 1 2 3 4 5 6 7 8 "Biotechnology Heritage Award". Science History Institute. 2016-05-31. Retrieved 1 February 2018.
  6. 1 2 3 Kuehn, Bridget M. (2018). "Modernizing medicines: FDA Stalwart Janet Woodcocklooks to the future of drug making and regulation" (PDF). Northwestern Medicine. FALL: 30–31. Retrieved 7 March 2019.
  7. 1 2 Center for Drug Evaluation and Research. "About the Center for Drug Evaluation and Research - Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research". www.fda.gov. FDA. Retrieved 22 February 2017.
  8. 1 2 3 4 5 Barlas, Stephen (July 2008). "FDA's Janet Woodcock Riding High: CDER Director Wins "Wows" Amid Agency Woes". Pharmacy and Therapeutics. 33 (7): 396–7. PMC   2740944 . PMID   19750117.
  9. ↑ Woodcock, Janet (September 2010). "Interview with Janet Woodcock". Bioanalysis. 2 (9): 1535–1538. doi:10.4155/bio.10.113. PMID   21083281.
  10. ↑ "FDA Names Permanent Director for Center for Drug Evaluation and Research". Fierce Biotech. March 11, 2008. Retrieved 7 March 2019.
  11. ↑ Dixon, Kim (March 12, 2008). "US FDA Veteran Woodcock to Lead Drugs Division". Reuters. Retrieved 6 March 2019.
  12. ↑ Norris, Sheena M. Posey; Strauss, Evelyn; DeFeo, Christopher; Stroud, Clare (2015). Financial incentives to encourage development of therapies that address unmet medical needs for nervous system disorders : workshop summary (Preprint) (PDF). Washington, D.C: National Academies Press. ISBN   978-0-309-37323-4. OCLC   927362841.
  13. ↑ Brennan, Zachary (3 August 2018). "An Interview With CDER Director Janet Woodcock". Regulatory Focus. Retrieved 6 March 2019.
  14. ↑ Institute of Medicine; Board on Health Care Services; National Cancer Policy Forum (2010). Patlak, Margie; Murphy, Sharon (eds.). A Foundation for Evidence-Driven Practice: A Rapid Learning System for Cancer Care: Workshop. National Academies Press. pp. 108–109. ISBN   9780309157476 . Retrieved 7 March 2019.{{cite book}}: |author3= has generic name (help)
  15. ↑ "S. HRG. 114–730 GENERIC DRUG USER FEE AMENDMENTS: ACCELERATING PATIENT ACCESS TO GENERIC DRUGS HEARING OF THECOMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED FOURTEENTH CONGRESS SECOND SESSION ONEXAMINING GENERIC DRUG USER FEE AMENDMENTS, FOCUSING ON ACCELERATING PATIENT ACCESS TO GENERIC DRUGS" (PDF). .S. GOVERNMENT PUBLISHING OFFICE. Printed for the use of the Committee on Health, Education, Labor, and Pensions. January 28, 2016. Retrieved 6 March 2019.
  16. ↑ "Implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) Testimony of Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration Before the Senate Committee on Health, Education, Labor, and Pensions January 28, 2016". Food and Drug Administration (FDA). 2019-02-08. Retrieved 6 March 2019.
  17. ↑ Wechsler, Jill (January 1, 2013). "Drug Quality at Center Stage for FDA and Manufacturers Shortages spur efforts to overhaul manufacturing oversight". BioPharm International. 26 (1). Retrieved 7 March 2019.
  18. ↑ Wechsler, Jill (July 2, 2017). "FDA Continues to Promote Quality Drug Production CDER's Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines". Pharmaceutical Technology. 41 (7): 20–26. Retrieved 6 March 2019.
  19. ↑ Center for Drug Evaluation and Research. "FDA Organization - Meet Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research". www.fda.gov. Retrieved 22 February 2017.
  20. ↑ "Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products". U.S. Department of Health and Human Services Food and Drug Administration. March 2004. Archived from the original on 2018-01-25. Retrieved 6 March 2019.
  21. 1 2 Woodcock, Janet; Woosley, Raymond (February 2008). "The FDA Critical Path Initiative and Its Influence on New Drug Development" (PDF). Annual Review of Medicine. 59 (1): 1–12. doi:10.1146/annurev.med.59.090506.155819. PMID   18186700 . Retrieved 6 March 2019.
  22. ↑ "Stagnation vs. Innovation: FDA's Critical Path Initiative". MasterControl. 17 April 2017.
  23. ↑ "Milestones in U.S. Food and Drug Law History". U.S. Food and Drug Administration. Retrieved 6 March 2019.
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  25. ↑ "Drug Safety Priorities 2016: Initiatives and Innovation". U. S. Food and Drug Administration. Retrieved 6 March 2019.
  26. ↑ Labbe, Colleen (2018-11-03). "Transcript: FDA's Adverse Event Reporting System (FAERS)". FDA. Retrieved 7 March 2019.
  27. 1 2 Mezher, Michael (3 February 2016). "Woodcock: Drug Safety Surveillance System Ready for Full Operation". Regulatory Focus. Retrieved 7 March 2019.
  28. ↑ Ball, R; Robb, M; Anderson, SA; Dal Pan, G (March 2016). "The FDA's sentinel initiative-A comprehensive approach to medical product surveillance". Clinical Pharmacology & Therapeutics. 99 (3): 265–268. doi:10.1002/cpt.320. PMID   26667601. S2CID   5129131.
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  30. ↑ Abbott, Ryan (2017). "Chapter 6 - The Sentinel Initiative as a Knowledge Commons". In Strandburg, Katherine J.; Frischmann, Brett M.; Madison, Michael J. (eds.). Governing Medical Knowledge Commons. Cambridge University Press. ISBN   9781316544587 . Retrieved 7 March 2019.
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  32. ↑ "Mylan CEO on EpiPen drug price controversy: "I get the outrage"" . Retrieved 2017-05-01.
  33. ↑ Serebrov, Mari. "PDUFA VI a must-pass enhancement and top priority for 21st Century Cures". BioWorld. Archived from the original on 23 March 2017. Retrieved 7 March 2019.
  34. ↑ "Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II) Testimony of Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Testimony of Peter Marks, M.D., Ph.D. Director, Center for Biologics Evaluation and Research Testimony of Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health Before the United States Senate Committee on Health, Education, Labor and Pensions March 21, 2017". U.S. Food and Drug Administration. March 21, 2017. Retrieved 7 March 2019.
  35. 1 2 "Biden urged not to give top FDA job to official over her role in opioid crisis". the Guardian. 2021-01-28. Retrieved 2022-11-18.
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  37. ↑ "2017 Innovations in Regulatory Science Awards". Reagan-Udall Foundation. 2017. Archived from the original on 8 March 2019. Retrieved 7 March 2019.
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  40. ↑ "22nd Annual Cancer Leadership Awards Reception". Friends of Cancer Research. September 20, 2018. Retrieved 7 March 2019.
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Janet Woodcock
Janet Woodcock (2021).png
Principal Deputy Commissioner of Food and Drugs
Assumed office
February 18, 2022
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