HHS OPDP Letter Rips Kadmon Pharmaceuticals for Marketing Claims
November 22nd, 2013 // 4:28 pm @ jmpickett
The Office Of Prescription Drug Promotion has sent a nasty warning letter to Kadmon Pharmaceuticals this month. The Department of Health and Human Services agency, which must ensure that drugmakers’ claims do not go too far, sent a stern warning letter to Kadmon regarding a letter that it sends out with the Ribasphere RibaPak.
OPDP stated that the marketing materials are stating that patients outside of the approved drug therapy claim could benefit. This constitutes making unsubstantiated claims of efficacy.
OPDP also seemed to be frustrated with the firm, based in Warrendale PA. It stated that these false and misleading claims are troubling because OPDP has stated its concerns in the past over related promotions, as recently as 2011. It referred to a notice that it sent about Infergen. The incident in 2011 is very similar to this most recent event. The agency at that time stated that the Infergen material omitted key facts and also overstated efficacy.
Kadmon is far from the first drug company to use marketing messages that go too far. Acorda recently was given a warning letter in August regarding a print ad for the drug Ampyra. However, the Kadmon letter stated that the company is engaged in particularly troubling activity, and is continuing to promote its drugs in a way that violate OPDP regulations.
The warning letter also advises that the marketing letter is misleading because it makes many claims about Ribasphere but does not note any risk information. The marketing letter does state taht the reader should read the safety information and black box warning that is included, but this statement and the separate document do not change that the firm has providing misleading information in the marketing letter.
