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Date Posted: 09:49:22 04/17/02 Wed
Author: hep_Rick
Author Host/IP: 653495hfc149.tampabay.rr.com / 65.34.95.149
Subject: HCV Activists Criticize Schering's "Access Assurance" program for PEG-Intron




HCV Activists Criticize Schering's "Access Assurance" program for PEG-Intron

The Hepatitis Activist and Advocacy Coalition in San Francisco (HAAC-SF) is calling on the US Food and Drug Admninistration (FDA) to investigate whether Schering-Plough's "Access Assurance" program for Peg Intron is using confidential patient information for marketing purposes.

Following is the text of a recent letter to the FDA from Brian Klein of HAAC-SF calling on the agency to investigate potential illegalities in the program that is operated for Schering-Plough by McKesson Pharmaceutical Health Solutions.
Jay Siegel,
Director OTRR, CBER
U.S. Food And Drug Administration
Woodmont Office Complex 1
1401 Rockville Pike, HFM-500
Rockville MD 20852

RE: Direct to Consumer Off-label Promotions in Schering-Plough Access Assurance Program

Dear Dr. Siegel:

As had been feared by health care providers and community advocates, the Schering-Plough Peg-Intron Access Assurance Registration Program, administered by McKesson Pharmaceutical Health Solutions, seems to be using the detailed confidential patient information it has gathered for more than just monitoring the distribution of a drug in limited supply. The patient information is now being used for off-label direct to consumer (DTC) marketing to promote continued use of Peg-Intron by some patients.

Our information suggests a program called the "Continuing Care Program" has been enacted. It is a follow-up program designed to sell Peg-Intron directly to patients who have failed Peg-Intron therapy previously. If a patient relapses or does not respond to Peg-Intron, McKesson staff contact the patient directly 6 months after treatment has ended to initiate a new round of treatment. Patient information is obtained from the Access Assurance database. Each day McKesson staff are given a list of patients to call who are "ready" for their next round of Peg-Intron. The database is designed to identify and list patients who are "eligible" for treatment again.

I believe that there are potential illegalities with the Continuing Care Program. I believe that calling patients directly to restart therapy constitutes a form of DTC advertising that could be illegal. I also believe that calling patients to initiate a second round of treatment on a product that is only FDA approved for "patients who have not been previously treated with interferon alpha" is off-label promotion.

I ask that CBER investigate this situation with Schering-Plough and McKesson as soon as is possible and stop this misuse of patients and their confidential information for marketing purposes. This Continuing Care Program makes it clearer than ever that the Access Assurance registration program was not designed to simply monitor distribution of a drug in limited supply but rather was designed specifically for marketing purposes, and to circumvent the intent of existing confidentiality laws and DTC promotion regulations.

Please contact me if you have any questions or would like to discuss this situation further. Thank you for your consideration and assistance in this matter.

Sincerely,

Brian D. Klein, MA, LMSW Co-founder, HAAC-SF Tel/fax: 415.863.5172

Cc: Richard Klein, Office of Special Health Issues, FDA

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Replies:

[> verrrly interesting Rick. -- Anna, 13:15:51 04/17/02 Wed (ip68-1-115-246.pn.at.cox.net/68.1.115.246)

Sounds illegal to me too. Shouldn't another round of treatment be between patient & doc?


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[> Hmmmmmmmm - i think i hear those black helicopters hovering - yikes! -- Perry, 16:14:21 04/17/02 Wed (netcache-1112.public.svc.webtv.net/209.240.222.32)


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