Client Alert: 2012 OPDP Warning and Untitled Letters

2222012 OPDP Warning and Untitled Letters
Date with
Hyperlink
to Letter
Drug and Indications Referenced
in Letter
Boxed
Warning
Form of
Communication
12
Summary of Alleged Violations
drug product, especially because the PI contains a Warning and Precaution
regarding gastrointestinal disturbances.
Omission of Material Facts:
o Brochure omits important information regarding the required course of
action in the event that a patient vomits after administration of the drug.
o Brochure suggests that Zmax demonstrates similar efficacy when
compared to a wide array of antibiotics when this is not supported by
substantial evidence or experience.
Broadening of Indication:
o
Brochure implies that Zmax is indicated to treat types of infections other
than acute bacterial sinusitis and community-acquired pneumonia by using
the word, “including,” after “certain infections” when Zmax is indicated to
treat specific conditions.
o Totality of brochure presentation suggests that Zmax is approved to treat
any conditions associated with a list of symptoms, including viral
infections that cause influenza or the common cold, when this has not been
demonstrated and the PI states that Zmax only works against bacteria.
Unsubstantiated Superiority Claim:
o
Claims suggest that Zmax is clinically superior to other antibiotics because
of its “1 day, 1 dose” dosage regimen, but clinical studies only
demonstrated that Zmax was non-inferior to other dosage regimens for
other antibiotics, so the claim is not supported by substantial evidence.
Misleading Efficacy Claims:
o
Brochure presentation misleadingly suggests that Zmax demonstrates
clinically significant efficacy for a period of time not demonstrated in
clinical trials. Clinical trials included evaluations 7 to 14 days post
treatment, but because Zmax is only administered one time as a single
dose, it is unclear exactly how long the extent of the therapeutic benefit is
maintained, so suggestion that the clinical effect lasts for 10 days following
administration is misleading.
Unsubstantiated Claims:
o
o
Claims suggest that adult patients and parents of pediatric patients would
take Zmax again if they were to have the same infection, but the telephone
survey responses used to support the claim are not sufficient support for
the outcomes claimed because the survey cannot adequately assess all
factors that may influence decisions to take any particular treatment again.
Claim suggests that treatment is “much easier” to complete as compared to
other antibiotic products, but the question used to support this claim is not
sufficient because it does not assess whether the effects of the drug,