New York's Senator
CHARLES E. SCHUMER

FOR IMMEDIATE RELEASE December 5, 2000


SCHUMER: DRUG COMPANY TO SUPPLY LAST-RESORT MEDICINE PROPULSID TO BUFFALO CHILDREN

After an emergency meeting in Washington with FDA and Janssen Pharmecutica, Schumer paves way for families to get limited access drug by Christmas

Buffalo victims waiting months for crucial medication will get relief free of charge

US Senator Charles E. Schumer today announced that families in need of the limited access drug Propulsid will obtain it by Christmas, after waiting for months. In a meeting today with the drug's manufacturer, Janssen Pharmaceutica, the Food and Drug Administration (FDA) and advocates representing the families, Schumer secured a commitment from Janssen to provide the families with the medication pending final action by their doctors.

Propulsid was taken off the general market last July because it was linked to serious cardiovascular side effects. Janssen established a limited access program so that the medication could be offered on a restricted basis to those families who desperately need it. This process, however, can take months to complete and leaves patients in need of the drug without any recourse, including families in Buffalo whose children depend on the drug to control their gastrointestinal disorders.

"This is a great Christmas present for the families that have been waiting for months to get this medicine for their children," Schumer said. "The FDA and Janssen both showed their compassion by paving the way for these families to get Propulsid by the holidays."

A month ago, several families asked Schumer for his help in obtaining the drug. Their family doctor, Dr. Tom Rossi of Rochester, had not yet received approval from their local Investigational Review Board (IRB) to administer the drug to patients, and the families were afraid they would run out of their Propulsid supply by Christmas.

At the meeting today, Janssen told Schumer about a new protocol they had just developed, the "60- day Supply Program," that would serve as a stopgap measure for patients in need of the drug but whose doctors were still in the process of receiving approval from their IRB. This measure would allow these doctors to have access to the medication in a 60-day supply for individual patients.

Schumer got the parties at the meeting to identify the barriers still standing in the way of the families and secured commitments from everyone to expedite the process for getting the drug.

With the final step entailing the local IRB's approval of documentation from the families' doctor, Schumer called Dr. Rossi to urge him to complete the process immediately and Rossi agreed to do so. As a contingency plan, Schumer called a second doctor based in Binghamton who has already been approved by an IRB and could serve as a backup referral.

Schumer said that the families in Buffalo who have been waiting for this medication will receive it free of charge from the drug company. Finally, Schumer said he will continue to help other families who have contacted him from around New York to obtain the drug.

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