Dr janet woodcock biography

American physician

Janet Woodcock (born Lordly 29, ) is an Indweller physician who served as First Deputy Commissioner of Food post Drugs from February until Feb , having previously served style Acting Commissioner of the U.S. Food and Drug Administration (FDA).^[2] She joined the FDA check , and has held neat as a pin number of senior leadership places or roles there, including terms as character Director of Center for Medication Evaluation and Research (CDER) use up to and to ^[3]

Woodcock has overseen the modernization and streamlining of CDER and FDA, onus new initiatives to improve high-mindedness timeliness and transparency of Bureau procedures, and the safety, figure and effectiveness of drugs. She informs the United States Coitus and other government bodies enquiry the FDA and its affairs, helping to develop policy recommendations and legislation. In , Woodcock received a Lifetime Achievement Accord from the Institute for Mild Medication Practices in recognition be more or less “a significant career history accord making ongoing contributions to untiring safety.”^[4] She has also agreed the Biotechnology Heritage Award.^[5]

Medical training

Woodcock received a Bachelor of Body of knowledge in Chemistry from Bucknell Academia in , and earned arrangement Doctor of Medicine from nobility Feinberg School of Medicine parallel Northwestern University Medical School encompass ^[6][3][5] She worked at significance Hershey Medical Center at University State University () and representation Veterans Administration Medical Center chuck out the University of California, San Francisco (),^[7] earning certifications take back Internal medicine () and Rheumatology ().^[8]

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research

Woodcock joined the U.S. Food become peaceful Drug Administration (FDA) in , as the Director of justness Division of Biological Investigational Pristine Drugs in the Center in favour of Biologics Evaluation and Research (CBER). As of September, , she became Acting Deputy Director attack CBER. She became Acting Superintendent of the Office of Therapeutics Research and Review (part find time for CBER) as of November , and was confirmed as Official of the Office of Therapeutics Research and Review as salary November ^[3]

Center for Drug Assessment and Research

From May to Apr Woodcock served as Director position the Center for Drug Appraisal and Research (CDER) of grandeur FDA.^[3]

Office of the Commissioner

From Apr to July , Woodcock was Acting Deputy Commissioner for Push at the FDA. From July to January , she served as Deputy Commissioner for Electioneer and Chief Operating Officer advice the FDA. From January convey March , she served since Deputy Commissioner and Chief Scrutiny Officer of the FDA.^[3][9]

Center let slip Drug Evaluation and Research

From Oct to March , Woodcock besides served as Acting Director ceremony the Center for Drug Analysis and Research (CDER). As concede March, , she became Leader of CDER, a position which she held until April 12, ^[10][11][8] In addition to duration the Director of CDER, she has concurrently served as Performing Director of the Office put Product Quality from October go up against September ; and as Activity Director of the Office misplace New Drugs from January cause somebody to December ^[3]

On April 12, , Woodcock transitioned from her character as Director of CDER indicate Principal Medical Advisor to interpretation Commissioner, while continuing to keep hold of as Acting Commissioner.

Contributions

As Pretentious of the Office of Therapeutics Research and Review (–), Woodcock covered the approval of authority first biotechnology-based treatments for diverse sclerosis and cystic fibrosis.^[3]

As President of CDER, beginning in , Woodcock oversaw the modernization adequate CDER and FDA, streamlining discussion processes and standards, transitioning difficulty electronic formats for submissions unacceptable decision-making processes, and making overseer procedures, policies, and decisions freely available. She has supported righteousness development of systems which justify a high degree of tell by consumers, patients, and their advocates.^{[3][5][12][13][14]}

It’s an ongoing intellectual unruly. It’s the intersection of skill and medicine and law suggest policy.

—&#;Janet Woodcock, ^[6]

Woodcock informs Hearing and other government bodies development the FDA and its deeds in order to guide game plan recommendations and legislation.^[8] She has testified before congress on condescension least 50 occasions, under shock wave different U. S. presidents.^[6][15][16] She has been praised for bunch up directness.^[8]

“Again, I want it overwhelm that I appreciate Dr. Woodcock’s candor,” intoned Mr. Dingell, whose committee has jurisdiction over blue blood the gentry FDA. “To her credit, she has stepped forth in authority midst of a public infirmity crisis to deal honestly assemble Congress. How I wish leftovers in the administration showed illustriousness same vigor, responsiveness, and leadership.”

—&#;Representative John Dingell (D-Mich.), ^[8]

Pharmaceutical First-class for the 21st Century

In Woodcock introduced the concept of danger management to the FDA's scrutiny of drug safety.^[5] In , she led the Pharmaceutical Upright for the 21st Century First move using a risk based close to modernize pharmaceutical manufacturing near regulation.^{[17][18][7][19]}

Critical Path Initiative

Beginning with rendering publication of Innovation or Stagnation: Challenges and Opportunity on excellence Critical Path to New Health check Products ()^[20] she has gorgeous the US Food and Treatment Administration's Critical Path Initiative^[5][3] unite an attempt to improve "development processes, the quality of remains generated during development, and distinction outcomes of clinical use manage these products."^[21] Through public-private partnerships and the creation of consortia, the initiative seeks to stick advances in genomics, advanced imagination, and other technologies to rectitude process of modern drug development.^[21][22] The goal is to explain rapidly develop new medical discoveries in the laboratory and regard them available to patients of great magnitude need.^[23][5][24]

Safe Use and Safety First

Woodcock has also worked to fix up the quality, effectiveness and conservation of drugs through the Embarrassed Use and Safety First initiatives, introduced in – Drug cover is viewed from a life-cycle perspective, examining each stage wages the product life cycle.^[25][3][4]

FDA Overt Event Reporting System (FAERS)

In , the FDA rolled out birth FDA Adverse Event Reporting Plan (FAERS), replacing the earlier AERS system. FAERS is an on the internet database that is used alongside the FDA for safety path of all approved drugs at an earlier time therapeutic biologic products. FAERS helps to track adverse event stake medication error reports from on the edge care professionals (physicians, pharmacists, nurses and others) and consumers (patients, family members, lawyers and others). It is used in mix with MedWatch and the Counteractive Adverse Event Reporting System (VAERS) is to identify potential security concerns.^[26][4]

Sentinel Initiative

Another monitoring system, righteousness Sentinel System, became fully effective in Woodcock launched the Watchman beacon Initiative in in response foul passage of the Food dominant Drug Administration Amendments Act well ("FDAAA"). The first Annual Vigil Initiative Public Workshop was booked in , with subsequent every year workshops to bring together conceivable stakeholders and explore a chunky range of perspectives and issues. In , the pilot info Mini‐Sentinel was launched. In , expansion to a full structure began.^[3][27][28] The Sentinel System draws on existing databases of top secret health care insurers and providers to actively monitor for protection issues as they are booming, rather than relying on late third-hand reports. Woodcock has designated that the approach could “revolutionize” product safety.^[29][30]

Generic drug programs

In Woodcock oversaw a major reorganization method the generic drug program.^[5] Position first generic drug user reward program, Generic Drug User Valuation Amendments of (GDUFA), was sign-language into law on July 9, ^[31] GDUFA was designed stumble upon build upon the year-old Remedy Drug User Fee Act (PDUFA) and improve the generic palliative review and approval process.^[32][3][27]

21st Hundred Cures Act

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

Controversy

Opioid crisis

On January 27, a coalescence of 28 public health assortments and opioid crisis organizations hurl a letter to the Biden Administration regarding Woodcock's position significance Acting Commissioner of the Agency. The letter said in end that "as the Director practice the FDA’s Center for Medicine Evaluation and Research (CDER) uncontaminated more than 25 years, Dr. Woodcock presided over one be required of the worst regulatory agency failures in U.S. history."^[35] Examples break into improper opioid decisions mentioned count on the letter include "approving Opana without adequate evidence of cover or long-term efficacy, approving Zohydro despite a vote of bite the bullet approval by a scientific counselling committee, and approving promotion stare OxyContin for children as pubescent as 11 years old."^[35]

Awards

The multitude are among the awards conventional by Woodcock:

• , Biotechnology Estate Award, Biotechnology Innovation Organization contemporary Science History Institute^[5]
• , Health Fanciful Award, Society for Women's Ailment Research ^[36]
• , inaugural Leadership Furnish, Reagan-Udall Foundation, for "lifetime benefaction and service to the specialization of regulatory science and universal health."^[37]
• , Florence Kelley Consumer Mastery Award, National Consumers League^[38]
• , Innovators in Health Awards, NEHI (Network for Excellence in Health Innovation)^[39]
• , Ellen V. Sigal Advocacy Command Award, Friends of Cancer Research^[40]
• , Lifetime Achievement Award, Institute make public Safe Medication Practices, given join “an individual who has locked away a significant career history faultless making ongoing contributions to longsuffering safety and has had first-class major impact on safe surgery practices.”^[4]
• , included in a queue of ten scientists who confidential had important roles in well-organized developments in compiled by class scientific journal Nature.^[41]

References

External links