Client Alert: 2012 OPDP Warning and Untitled Letters

More documents

Recommendations

Info

2222012 OPDP Warning and Untitled Letters Date with Hyperlink to Letter Drug and Indications Referenced in Letter Boxed Warning Form of Communication Summary of Alleged Violations symptom of nasal congestion when that has not been demonstrated because clinical studies assessed a composite measure of nasal symptoms and not individual symptoms. o Script implies that the clinical symptom of allergic rhinitis will be relieved “rapidly” and “within 30 to 45 minutes” of the administration of the drug, but FDA is not aware of substantial evidence and clinical experience to support the claim. Failure to Fulfill “Adequate Provision” Requirement: o Script fails to either present a brief summary of required information or make adequate provision for dissemination of the PI. 05-24-2012* EpiPen® and EpiPen® Jr. For the emergency treatment of allergic reactions (Type I) including anaphylaxis to… allergens, as well as idiopathic anaphylaxis and exercise-induced anaphylaxis. No Direct-to- Consumer Broadcast Television Advertisement † Overstatement of Efficacy: o The overwhelming impression of the presentation in the ad implies that EpiPen alone obviates the need for taking precautionary measures and provides protection against any potential risks due to exposure to an allergen when this has not been demonstrated and the PI states that the EpiPen is emergency supportive therapy. o Statement that EpiPen cannot eliminate the risk of anaphylaxis does not mitigate the overall misleading impression. 8
2222012 OPDP Warning and Untitled Letters Date with Hyperlink Drug and Indications Referenced to Letter in Letter 05-25-2012 Incivek For the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers. 06-07-2012 Sodium Ferric Gluconate Complex in Sucrose For treatment of iron deficiency anemia in adult patients and in pediatric patients aged 6 years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy. Boxed Form of Warning Communication Summary of Alleged Violations No Branded Story Overstatement of Efficacy: o Claims may be an accurate reflection of the patient’s own experience, but story implies that most or all cirrhotic prior null responders infected with hepatitis C will successfully achieve Sustained Virologic Response (SVR) on Incivek combination therapy, but one patient’s treatment response does not constitute substantial evidence for this claim, clinical trials do not support this misleading impression, and the PI states that a high proportion of previous null responders with cirrhosis did not achieve SVR. o Claims overstate efficacy by suggesting that the usual outcome of treatment is a positive effect on the patient’s interpersonal relationships, physical functioning, work productivity, and overall quality of life, but FDA is not aware of substantial evidence or clinical experience to support these claims. Omission of Material Fact: o Claims of patients “clear[ing]” the virus implies removal of the hepatitis C virus (HCV) from the body when this is not the case because patients with undetectable HC-RNA levels after therapy may still have replication competent virus. Minimization of Risk Information: o Story minimizes the risk of rash and alopecia associated with Incivek combination therapy because it suggests that a rash is not a serious side effect when this is not the case and serious skin reactions have been reported in patients. o Accompanying the story with a slide deck of important safety information does not mitigate the misleading minimization of risk information regarding rash. o The PI warns that Incivek must not be administered as a monotherapy and must only be prescribed with both peginterferon alfa and ribavirin, for which alopecia is a common adverse reaction, so implication that the side effect is “nothing” minimizes the risk. No Journal Ad Unsubstantiated Claims: o Claims suggest that sodium ferric gluconate has been proven to reduce the need for erythropoiesis-stimulating agents (ESA) during treatment, but reduced ESA dose requirements can be due to multiple confounding factors, making it difficult to identify the specific cause for any reductions in ESA dosing, so epoetin dose reduction is not a valid or appropriate endpoint for assessing the truth efficacy of sodium ferric gluconate. o The cited reference is not sufficient support because it discusses a 9
Page 1 and 2: Warning Letters indicated with * by
Page 3 and 4: 2222012 OPDP Warning and Untitled L
Page 7: 2222012 OPDP Warning and Untitled L
Page 21: 2222012 OPDP Warning and Untitled L

Client Alert: 2012 OPDP Warning and Untitled Letters

Create successful ePaper yourself

Delete template?

Save as template?