Purdue Pharma's Killer Surprise for American Children

Addicting 7 to 16 year olds to hard drugs is not a happy surprise.

A "lucrative opportunity": The new opioid Butrans is targeted for children ages 7 to 16 years old.

(MYRTLE BEACH, SC) - On September 14, the FDA Advisory Committee will be holding a hearing on Purdue Pharma's new "blockbuster" opioid called Butrans. It is targeted for severe pain in children ages 7 to 16 years old.

There is not a doubt in my mind that once the FDA approves this latest killer opioid presented by Purdue Pharma, it will be off-labeled marketed as OxyContin was for all pain levels.

This time though children are the guinea pigs and Purdue Pharma and its owners, the Sacklers will in all probability double their profits.

Below is the FDA Advisory Committee posting on the hearing scheduled for September 14. Since the FDA functions completely with impunity -- no accountability, conscience or responsibility to the safety of the American people, the FDA does not have to list who Purdue Pharma's expert witnesses will be at the hearing. The hearing will also not be webcast to the public.

There is little outrage from the public in Purdue Pharma targeting children as young as 7 years old with yet another Holocaust of death in an FDA approved opioid.

The organizations pushing for the use of Suboxone and Naloxone in the treatment of drug addiction in adults may want to pitch a dosage conversion table for these "miracle treatments" when children become hopelessly addicted to Butrans.

As a bit of history for those not knowledgeable, in the late 1990's, a little known pharmaceutical company headquartered in Stamford, Connecticut unleashed a powerful prescription opioid called OxyContin -- after approval by the FDA.

OxyContin is infamous now as being a dangerous opioid responsible for tens of thousands of deaths and addictions throughout every state in the country. We now have states of emergency in the prescription opioid/heroin epidemic.

The surge of heroin use has also been attributed to the widely prescribed OxyContin.

Purdue Pharma's revenues rose sharply over the years from approximately a few million dollars a year to billions of dollars a year thereby making the Sackler Family (owners of Purdue Pharma) one of the ten richest families in America.

In 2002 after losing my daughter to prescribed OxyContin, I made it my mission to learn everything I could about the marketing of OxyContin. My research led to working with the Department of Justice and charges being lodged against Purdue Pharma for the criminal marketing of OxyContin to physicians and patients as non-addictive.

I also testified against the criminal pharmaceutical company in 2007 when they pleaded guilty in federal court to charges against them and also in front of the U.S. Senate Judiciary Committee.

As I was researching and uncovering more and more criminal marketing of OxyContin, I also was emailing and faxing correspondence to the FDA.

The FDA over a short period of years had mailed Purdue Pharma no less than 12 warning letters about their less than honest marketing of OxyContin. At one point, I received a telephone call from Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP).

Mr. Abrams sounded as though he were annoyed that I would be questioning the lack of action by the FDA against Purdue Pharma.

I challenged him with "how many warning letters do you plan on sending Purdue Pharma because Mr. Abrams, they don't appear to be listening to you?" His reply stunned me. It was "We don't have the manpower to police Purdue Pharma."

My closing remark to him was "And you don't think Purdue Pharma doesn't know that?" Mr. Abrams hung up on me.

How many warning letters do you imagine the FDA will be sending Purdue Pharma about the criminal marketing of Butrans?

A blind eye by the public compliments of Purdue Pharma and the FDA -- a perfect storm for your children's worst nightmare.

Scary? You bet it is.

UPDATED PUBLIC PARTICIPATION INFORMATION: September 14, 2017:

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

UPDATED INFORMATION (as of 8/17/2017): The public participation information has been changed for the September 14, 2017, joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
The deadline for making formal oral presentation requests has been changed from Tuesday, August 22, 2017 to Monday, August 28, 2017 and the contact person will now notify interested persons regarding their request to speak by Tuesday, August 29, 2017. All other information remains the same.

ORIGINAL INFORMATION
Center: CDER
Date: September 14, 2017
Time: 8:00 a.m. to 12:30 p.m.
Location: Tommy Douglas Conference Center
10000 New Hampshire Avenue, Silver Spring, Maryland 20903

Agenda

The committees will discuss supplemental new drug application (sNDA) 021306, for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The committees will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2017 Meeting Materials, Anesthetic and Analgesic Drug Products Advisory Committee

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4836. The docket will close on September 13, 2017. Submit either electronic or written comments on this public meeting by September 13, 2017.
Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 13, 2017.

The www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 13, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before August 30, 2017, will be provided to the committees. Comments received after that date but by September 13, 2017 will be taken into consideration by the Agency.

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.
  

  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process.
  

  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-4836 for "Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Request for Comments." Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments.
  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential."
  Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11:15 a.m.

Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2017.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 23, 2017.

Webcast Information:

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the joint Anesthetic and Analgesic Drug Products Advisory Committee meeting and the Drug Safety and Risk Management Advisory Committee.

Contact Information

• Stephanie L. Begansky, PharmD
  Center for Drug Evaluation and Research
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD 20993-0002
  Phone: 301-796-9001
  Fax: 301-847-8533
  E-mail: AADPAC@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area
  Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie Begansky at (301) 796-9001 at least seven (7) days in advance of the meeting.

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Please visit our website at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).