Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA).[2] She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.[3]
Woodcock has overseen the modernization and streamlining of CDER and FDA, introducing new initiatives to improve the timeliness and transparency of FDA procedures, and the safety, quality and effectiveness of drugs. She informs the United States Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation.
In 2015, Woodcock received a Lifetime Achievement Award from the Institute for Safe Medication Practices in recognition of “a significant career history of making ongoing contributions to patient safety.”[4]
She has also received the 2019 Biotechnology Heritage Award.[5]
Woodcock joined the U.S. Food and Drug Administration (FDA) in 1986, as the Director of the Division of Biological Investigational New Drugs in the Center for Biologics Evaluation and Research (CBER). As of September, 1990, she became Acting Deputy Director of CBER. She became Acting Director of the Office of Therapeutics Research and Review (part of CBER) as of November 1992, and was confirmed as Director of the Office of Therapeutics Research and Review as of November 1993.[3]
From April 2004 to July 2005, Woodcock was Acting Deputy Commissioner for Operations at the FDA.
From July 2005 to January 2007, she served as Deputy Commissioner for Operations and Chief Operating Officer of the FDA.
From January 2007 to March 2008, she served as Deputy Commissioner and Chief Medical Officer of the FDA.[3][9]
Center for Drug Evaluation and Research
From October 2007 to March 2008, Woodcock also served as Acting Director of the Center for Drug Evaluation and Research (CDER). As of March, 2008, she became Director of CDER, a position which she held until April 12, 2021.[10][11][8]
In addition to being the Director of CDER, she has concurrently served as Acting Director of the Office of Product Quality from October 2014 to September 2015; and as Acting Director of the Office of New Drugs from January 2017 to December 2018.[3]
On April 12, 2021, Woodcock transitioned from her role as Director of CDER to Principal Medical Advisor to the Commissioner, while continuing to serve as Acting Commissioner.
Contributions
As Director of the Office of Therapeutics Research and Review (1992–1994), Woodcock covered the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.[3]
As Director of CDER, beginning in 1994, Woodcock oversaw the modernization of CDER and FDA, streamlining review processes and standards, transitioning to electronic formats for submissions and decision-making processes, and making regulatory procedures, policies, and decisions publicly available. She has supported the development of systems which encourage a high degree of participation by consumers, patients, and their advocates.[3][5][12][13][14]
It’s an ongoing intellectual challenge. It’s the intersection of science and medicine and law and policy.
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.”
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]
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:
2017, inaugural Leadership Award, Reagan-Udall Foundation, for "lifetime contributions and service to the field of regulatory science and public health."[37]
2015, Lifetime Achievement Award, Institute for Safe Medication Practices, given to “an individual who has had a significant career history of making ongoing contributions to patient safety and has had a major impact on safe medication practices.”[4]
2021, included in a list of ten scientists who had had important roles in scientific developments in 2021 compiled by the scientific journal Nature.[41]
^ abcdefghijkl"Janet Woodcock". The National Academies of Sciences, Engineering and Medicine. Archived from the original on 6 March 2019. Retrieved 5 March 2019.
^Romero, K; de Mars, M; Frank, D; Anthony, M; Neville, J; Kirby, L; Smith, K; Woosley, R L (October 2009). "The Coalition Against Major Diseases: Developing Tools for an Integrated Drug Development Process for Alzheimer's and Parkinson's Diseases". Clinical Pharmacology & Therapeutics. 86 (4): 365–367. doi:10.1038/clpt.2009.165. PMID19763117. S2CID28813390.
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