A friend of mine named Ed Silverman writes a blog called Pharmalot and posts timely tidbits about the pharmaceutical industry and the Food and Drug Administration (FDA).
Ed recently wrote about a new outreach program on the FDA’s website, which solicits questions from the public for Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. They call it the CDER Director’s Mailbag.
Woodcock is the FDA’s top drug regulator and one of the chief promoters of the agency’s “Fast Track” development program, which speeds up the approval process for new drugs. She is also a driving force behind the FDA’s Risk Evaluation and Mitigation Strategy for opioid painkillers, which asks drug makers to develop new programs to retrain medical practitioners on opioid safety.
In early 2009, Woodcock was under serious consideration by the incoming Obama administration for FDA commissioner. Woodock didn’t get the job, perhaps because she was seen as too cozy with drug makers. There was also an embarrassing revelation that the FDA spent $1.5 million on a contract with a public relations firm that often does work for the pharmaceutical industry.
Some of that $1.5 million was spent on a seminar for FDA managers to “improve workplace leadership” and “empower staff.” A slide presented during the seminar depicted Woodcock as a “visionary leader” on par with Golda Meir, Margaret Thatcher and Indira Ghandi, among others.
Which brings us back to the FDA website and Janet Woodcock’s mailbag.
Just in case it is not another effort to promote Woodcock as a “visionary leader,” I have a few questions on behalf of the tens of thousands of families throughout the country whose loved ones are dying and becoming addicted to opioids under the guise of “safe for chronic, moderate pain.”
One question being: How many more lives do you need destroyed before you regulate these lethal opioids for severe pain only? The Risk Evaluation and Mitigation Strategy (REMS) paper trail you initiated years ago is proving absolutely worthless — you know it and I know it. Asking the pharmaceutical companies to write up their own REMS when they are responsible for pushing these dangerous drugs for moderate pain just reinforces the FDA’s allegiance to the pharmaceutical industry.
Having worked with the FDA over the years and seeing first hand their stonewalling when any controversial question is asked of them, don’t be too encouraged that Woodcock will bring about change. My guess is her “mailbag” is just another public relations ploy used by the agency to give false hope to the public that the FDA is working hard to combat the prescription drug epidemic.
Maybe the FDA is preparing for the investigation by the U.S. Senate Finance Committee and Woodock will be the “go to” person representing the agency at its hearings. Hopefully, the committee will not buy what Woodock is selling and convene an investigation of the FDA itself. I believe families devastated by the prescription drug epidemic are entitled to this at the least — especially if FDA ties to the pharmaceutical industry are uncovered.
Marianne Skolek is an activist and investigative reporter for Salem-News.com who lost a daughter to prescribed OxyContin in 2002. Marianne writes from the perspective of families devastated by the prescription drug epidemic.
The views, opinions and positions expressed in this column are the author’s alone. They do not inherently or expressly reflect the views, opinions and/or positions of American News Report, Microcast Media Group or any of its employees, directors, owners, contractors or affiliate organizations. American News Report makes no representations as to the accuracy, completeness, currentness, suitability, or validity of any information in this column, and is not responsible or liable for any errors, omissions, or delays (intentional or not) in this information; or any losses, injuries, and or damages arising from its display, publication, dissemination, interpretation or use.
Opposing views, opinions and positions about this column are welcomed by American News Report and or Microcast Media Group. Publication or lack of publication of opposing views, opinions and/or positions does not imply, suggest or expressly reflect an endorsement or disapproval of the originating commentary on the part of American News Report or Microcast Media Group.