Healthy Skepticism Library item: 12104

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Koroneos G.
In Defense of Peer Review: Waxman Opponents Argue for Distribution of Off-Label Info
PharmExec.com 2007 Dec 5
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=477262

Full text:

Supporters of a draft policy that would allow pharma companies to distribute off-label product information published in medical journals to physicians without prior approval by FDA have come out against Congressman Henry Waxman (D-CA), stating that he has attacked the purpose of peer-reviewed material.

“The policy paper that Congressman Waxman seeks to halt serves an important public health purpose: Its adoption would enable clinicians practicing in some of the most difficult areas of medicine-oncology, psychiatry, and pediatrics-to be better informed and to more quickly and effectively treat patients,” said John Kamp, executive director of the Coalition for Healthcare Communication.

The proposed guidance would allow pharma companies to send unmodified articles published in peer-reviewed medical journals to physicians, as long as the information isn?t attached to any promotional material. The articles would not have to be approved by FDA, a big change from current policy, which requires prior approval before distribution.

The congressman spoke out against the guidance in a letter to FDA Commissioner Andrew von Eschenbach, claiming that pharma companies would be less likely to regulate the quality of the reports and studies sent to pharma companies. He stated that the policy “would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.”

“In seeking to derail the policy paper, Congressman Waxman also attacked the integrity of articles that appear in peer-reviewed journals and the peer-review process itself,” Kamp said. “This attack is unconscionable and contrary to the uniformly accepted way that science advances on a worldwide basis.”