Tough FDA Veteran Woodcock May Block Re-Sked "Pathway"
Having survived countless attacks on her judgement during her 37-year tenure at the FDA, Dr Janet Woodcock failed last year to be named FDA commissioner, and now finds herself at the helm of all cannabis-regulatory oversight at the agency.

"We intend to work extensively with stakeholders" in gathering relevant data on THC formats, dosing,  testing protocols, side effects and symptom relief, which may take some additional years even as the Biden administration called for "expeditious" review of THC/CBD placement on schedule 1.  Woodcock told a Oct 27 CFCR seminar that her agency working along with National Institute of Drug Abuse(NIDA) will first need to complete it's "8-Factor Test", then send its recommendation on safety/efficacy to the DEA.  
         Repeating FDA's non-stop call for cannabis/THC safety data, Woodcock failed to acknowledge that clinical research for cannabis under a schedule 1 designation is very difficult for researchers.  Congress is considering a standalone research bill to get around the thorny schedule 1 issues.    Among the health issues still needing close examination by her group will include:

    The Oct 27 webinar also heard from Dr. Steven Courneyer -- head of the FDA’s Cannabis Product Committee (CPC),  Without citing any time-line, Courneyer also set a "from square-one" tone on getting FDA review moving on rescheduling potential.    Industry leaders seemed generally disappointed that the Biden Directive may be substantially slowed with current FDA staff, addinig that an appeal to FDA Commissioner Dr. Robert Calif-- and perhaps to Health and Human Services secretary Xavier Becerra may be needed for quicker review.

       Liberal groups have jumped into the fray as well, decrying Woodcock as an industry-friendly regulator amid a broader campaign for Biden to nominate an FDA chief who would put far more distance between the agency and the drugmakers that it oversees.     “We basically have regulatory capture at the agency, which has corrupted and undermined the decision-making process,” said Michael Carome, director of the health research group at Public Citizen, who sparred with Woodcock last year over the agency’s support of an Alzheimer’s drug that was near-unanimously rejected by an expert panel. “She’s a bad choice.”

         Woodcock also played a central role in the 2016 approval of a muscular dystrophy medicine from Sarepta despite thin data and objections from drug reviewers like Ellis Unger, who filed a formal complaint against her. Even Woodcock’s broad-based support within the scientific research community has come under scrutiny of late, with critics pointing to the drug industry funding underpinning boosters like the influential Friends of Cancer Research.  Woodcock, who has pushed the FDA to consider the drug industry a partner and not an adversary, came under intense criticism for her role in allowing Oxycontin (first in 1995) to gain greater medical acceptance as Woodcock's FDA  played a critical role "by overseeing continuous approvals of stronger and more addictive opioids and failure to see contain consumer deaths as the Sackler family's Perdue Pharma flooded the U.S. with millions of doses with little constraint.   

       In a letter to the administration, 28 groups accused Dr Janet Woodcock of presiding over “one of the worst regulatory agency failures in US history” as head of the FDA department responsible for approving new prescription opioids, the Center for Drug Evaluation and Research (CDER). Speaking last year at an event installing new FDA head Calif, she said “The projection of the harms and the projection of the behaviors was way off,” said Woodcock, saying the FDA’s harm and risk analysis of new drugs can be “difficult to predict” .

“In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter said.

Below -- Oct. 27 FDA Webinar panelists with (top) Woodcock, below CFCR's Sarah Clark, FDA's Patrick Cournoyer, and CFCR co-founder Sheri Ostrowitz.  Pathways chart below.