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FDA Warning letter to Kadmon Pharmaceuticals
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FDA Warning Letter:
pdf
Download the PDF here
Download the PDF here
"The FDA today posted on its website a letter sent to Kadmon Pharmaceuticals regarding an Intro Letter for RibasphereA RibaPakA Tablets complaining that the letter "suggests that the drug is useful in a broader range of patients or conditions than has been substantiated, omits material facts, and makes unsubstantiated efficacy claims."......http://www.topix.com/forum/health/hepatitis/TFHVTUEOG1CK1S6UB
"company also had what FDA called a "particularly troubling" history with FDA going back to March 2011, when FDA sent it a similar Warning Letter regarding Infergen (interferon alfacon-1), an injectable drug also used in the treatment of hepatitis C."......"OPDP is concerned that Kadmon is continuing to promote its prescription products in a violative manner," FDA wrote....."As of the time of this article's publication, the company had taken down its website for Ribapak, but a version was still up on the company's main website making claims similar to the ones noted in the Warning Letter."
FDA Sends Letter to Kadmon Pharmaceuticals Regarding Intro Letter
http://www.drugs.com
SILVER SPRING, Md., Nov. 20, 2013 - The FDA today posted on its website a letter sent to Kadmon Pharmaceuticals regarding an Intro Letter for Ribasphere® RibaPak® (ribavirin, USP) Tablets (Ribasphere) complaining that the letter "suggests that the drug is useful in a broader range of patients or conditions than has been substantiated, omits material facts, and makes unsubstantiated efficacy claims."
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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.
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Kadmon Warned Again for Misleading Claims in Advertisements
http://www.fdanews.com
Kadmon Pharmaceuticals has once again been warned by the FDA for making misleading claims in advertisements, this time for omitting risk information and falsely implying that its hepatitis C drug Ribasphere is a monotherapy.
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Kadmon Hit with Second FDA Warning Letter in Three Years for Alleged Advertising Failures
20 November 2013
http://www.raps.org/focus-online/news/news-article-view/article/4341/kadmon-hit-with-second-fda-warning-letter-in-three-years-for-alleged-advertisin.aspx
By Alexander Gaffney, RF News Editor
Pharmaceutical manufacturer Kadmon Pharmaceuticals has been issued a Warning Letter by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), with regulators saying that one of the company's promotional materials promotes an indication beyond that which has been approved by FDA while making unsubstantiated claims and omitting facts.
Background
The letter, posted online 20 November 2013, references a letter submitted under Form 2253 and intended to support Ribasphere RibaPak (ribavirin, USP) Tablets. The drug, used to treat hepatitis C, is a twice-per day combination therapy drug that is specifically contraindicated for monotherapy use.
The company's website touts the drug as being advantageous because of its unique packaging design. "Each package provides 7 days of treatment divided into morning and evening doses," it says. "This packaging is designed to simplify treatment, make it easier to remember to take your medication, and also help you keep track of how many pills you've taken."
The drug is also associated with some serious risksÑenough so that it is paired with a medication guide (MedGuide) and a voluntary pregnancy registry to avoid the risk of birth defects.
Allegations
But according to FDA's Warning Letter to Kadmon, the company reportedly downplayed these risks in its two-page promotional letter to healthcare providers. The letter makes "numerous claims regarding the benefits of Ribasphere, but fails to include any risk information associated with the drug in the body of the letter," FDA wrote. While the back of the letter included the full prescribing information, its inclusion did not serve to "mitigate the misleading representations within the body of the letter."
Regulators also claim the company's claims serve to expand its approved indication by implying that the drug could be used by itself. Regulators called this an "overwhelmingly misleading impression," even despite a brief mention of the drug's use with peginterferon injections.
In addition to omitting risks, Kadmon was also charged with omitting material facts, such as information that would ordinarily be found under the "Indications and Usage" section of the prescribing information (PI). Specifically, FDA said the omission of information about the trial used to support approval and its limitations was impermissible.
Regulators also flagged what they called "unsubstantiated efficacy claims" that use of the drug would result in improved rates of sustained viral response (SVR) and patient adherence. Those outcomes have not been borne out through substantial evidence, FDA noted.
Altogether, the claims made against Kadmon are substantial, especially considering the length of the text in the letter. All of FDA's complaints came from text that is not even 200 words in length and spans just part of a single page.
Second Letter Since 2011
Alone, the problems may well have been enough to warrant a Warning Letter instead of the Untitled Letters most often sent by OPDP for alleged advertising violations. However, the company also had what FDA called a "particularly troubling" history with FDA going back to March 2011, when FDA sent it a similar Warning Letter regarding Infergen (interferon alfacon-1), an injectable drug also used in the treatment of hepatitis C.
"OPDP is concerned that Kadmon is continuing to promote its prescription products in a violative manner," FDA wrote.
As of the time of this article's publication, the company had taken down its website for Ribapak, but a version was still up on the company's main website making claims similar to the ones noted in the Warning Letter.
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Sam Waksal, A Hepatitis C Medicine And An FDA Warning Letter
Nov 21 2013 by Ed Silverman Pharmalive.com
http://www.pharmalive.com/sam-waksal-a-hepatitis-c-medicine-and-an-fda-warning-letter
As a new batch of hepatitis C treatments emerges from the pharmaceutical pipeline, drugmakers are scrambling to position themselves to grab a chunk of what Wall Street estimates could be a $15 billion market. And Kadmon Pharmaceuticals is no exception, although its prized possession is an older treatment called Ribasphere that is currently used as part of a combination treatment and is being tested with forthcoming medicines.
Kadmon, however, may have been a bit too eager to ensure the medical community is aware of Ribasphere, a name for ribavirin. The FDA has issued a scathing warning letter in response to a letter the drugmaker wrote to physicians. In its own missive, the agency writes that the numerous violations are "concerning from a public health perspective" and that one violation was "particularly egregious."
Specifically, the agency chastised Kadmon because its letter suggests that Ribavirin can be used in a broader range of patients and conditions than has been substantiated; material facts were omitted; unsubstantiated effectiveness claims were made and evidence was provided that indicate Ribavirin is intended for a new use that has not been approved (here is the Kadmon letter to physicians).
The ceo at Kadmon, by the way, is Sam Waksal. If the name is not familiar, Waksal is the former ImClone Systems ceo who was convicted of insider trading in a scandal that also snared his friend, Martha Stewart. After leaving federal prison three years ago, he raised a reported $50 million from to form Kadmon. You can see Sam here although, curiously, the Kadmon web site was not working this morning.
This is, in fact, the second time the FDA has issued a warning letter to Kadmon for its activities in the past couple of years. In May 2011, the agency slammed the drugmaker for similar violations contained in a physician letter sent by Three Rivers Pharmaceuticals to promote its Infergen hepatitis C treatment. At the time, a spokesman maintained that letter was issued before Kadmon purchased Three Rivers (back story).
In any event, Sam & Co. do not have such an excuse this time.
The FDA was especially troubled by language in the Ribasphere letter that suggested the medicine may help improve patient adherence and lead to improved rates of sustained virologic response, which is a way to gauge whether a treatment is effective, all by itself. You may recall that ribavirin must be taken with peg-intron, an injectable medicine that, typically, causes very unpleasant side effects.
The Kadmon letter, however, "misleadingly broadens the patient population" by implying Ribasphere is approved as a monotherapy to treat all hepatitis C patients "when this has not been demonstrated by substantial evidence or substantial clinical experience," the FDA writes. This is the violation that the agency found particularly egregious.
The other violations can be seen in the FDA letter, which is here.
As for Kadmon, a spokesman sent us this statement: "We are in receipt of the FDA's communication and look forward to working with the Agency toward an appropriate resolution."
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