July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, Coalition for Healthcare Communication Executive Director John Kamp told The Washington Post last week.
In the July 9 article, “FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules,” Kamp and other industry experts comment on which direction the FDA should take as it reviews its position on what off-label use information companies can disseminate to physicians.
“If doctors can talk to each other and major researchers can talk about off-label uses, the drug’s manufacturer should be able to talk about those uses, too,” Kamp told the Post. “If something is true and can be said by one party, it can be said by all other parties.”
Jeff Francer, vice president and senior counsel, Pharmaceutical Research and Manufacturers of America, also is quoted in the article: “Right now, the FDA essentially prohibits the communication of large swaths of information that is truthful and not misleading,” Francer said. “That information can be extremely beneficial.”
Although others state that the FDA should err on the side of caution and make companies prove that their drugs work for off-label uses before discussing them with doctors, Kamp asserts that changing the regulations to allow for truthful exchanges between companies and physicians would be “a step forward for patients and doctors.”
To read the full Post article, go to: http://m.washingtonpost.com/national/health-science/2014/07/09/3708dd6a-fbc4-11e3-8176-f2c941cf35f1_story.html?wprss=rss_national