NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

Dingell, Stupak Question FDA’s Re-approval of ProHeart6

Reps. John D. Dingell, Chairman of the Committee on Energy and Commerce and Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, today pressed the Food and Drug Administration (FDA) to explain why it approved the return of ProHeart 6, a canine heartworm treatment, to the market.

In two letters sent to the FDA, the congressmen specifically asked for information and documents leading up to the agency’s decision to re-approve ProHeart6.

“In light of the serious, life-threatening reactions associated with ProHeart 6, the Committee is concerned that there is simply not enough new data to justify reintroduction of this controversial product to the market,” said Dingell.

Wyeth Pharmaceuticals recalled ProHeart 6 in September 2004, after Dr. Victoria Hampshire, former Adverse Event Coordinator for FDA’s Center for Veterinary Medicine (CVM), demonstrated to FDA managers that the drug was causing an inordinate number of illnesses and death in dogs treated with the drug.

Shortly thereafter, in January 2005, FDA convened a Veterinary Medicine Advisory Committee (VMAC) meeting to evaluate the safety of ProHeart 6. The overwhelming consensus of the VMAC was that more data including targeted animal safety studies, was needed to establish the risks associated with the use of ProHeart 6.

Nevertheless, according to the Summary of the Supplemental New Animal Drug Application (NADA) for ProHeart 6, “CVM did not require target animal safety studies for this supplemental approval.”

“Given the safety concerns raised in connection with the use of ProHeart 6 in dogs, shouldn’t CVM have convened a VMAC or other independent public forum to thoroughly evaluate the safety and risks of the drug before reintroduction to the market?” questioned Stupak.

Earlier this year, Senator Chuck Grassley (R-IA) issued a report resulting from his investigation into charges that ProHeart’s manufacturer, Wyeth Pharmaceuticals, instigated a retaliatory smear campaign against Dr. Hampshire culminating in a referral for criminal prosecution. As a consequence, FDA managers removed Dr. Hampshire from her duties in connection with ProHeart 6. Grassley requested that Chairmen Dingell and Stupak review the report and assist in his investigation of FDA’s mishandling of an internal investigation of Dr. Hampshire.

Read the document request letter »
Read the information requestion letter »

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