Both healthcare providers and consumers have expressed concerns to FDA about the effectiveness of its regulation of manufacturers'
DTC prescription-drug advertising, especially as it relates to assuring balanced communication of risks compared with benefits,
specified the notice. One characteristic of DTC television broadcast ads is the use of compelling visuals. Many assert that
the visuals present during the product-risk presentation are virtually always positive in tone and often depict product benefits.
A consistently raised question is whether advertising visuals of benefits interferes with consumers' understanding and processing
of the risk information in the ad's audio or text. Comments are due Oct. 22, 2007. -Patricia Van Arnum
In an Aug. 31 press release, Boehringer Ingelheim (Ingelheim, Germany) decided to voluntarily withdraw its "Silomat" drug,
which contains clobutinol hydrochloride, in all countries where it is available. The company advised consumers to stop using
the drug. Boehringer recently analyzed new findings from a clinical study it performed in healthy subjects that suggest that
clobutinol hydrochloride carries the potential risk of cardiac arrhythmia. Although the risk might be low, the company decided
to recall the drug in the interest of patients' safety. Boehringer described the recall as a precautionary measure and noted
that therapeutic alternatives to the product are available.
NEW DRAFT GUIDANCE
FDA Issues Draft Guidance for Pharmacogenomic Data Submissions
The US Food and Drug Administration issued a draft guidance, Pharmacogenomic Data Submissions Companion Guidance, on Aug. 29, to be used as a companion to an earlier guidance, Pharmacogenomic Data Submissions, which was issued in March 2005. The draft guidance explains the procedure for voluntary genomic data submissions and marketing
submissions containing genomics data. These submissions can be part of investigational new drug applications, new drug applications,
or biologics license applications. The recommendations are intended to facilitate progress in pharmacogenomics and pharmacogenomic
data use in drug development. The draft guidance addresses methodological issues that should be considered when submitting
gene expression data from microarrays, including:
- RNA isolation, handling, and characterization
- Labeling systems
- Hybridizations for microarrays
- Fluorescence reader settings for microarrays
- Differentially expressed genes
- Proficiency testing.
Comments about the draft guidance are due Nov. 27, 2007. -Patricia Van Arnum
FDA Finalizes Guidance on Biologics Manufacturing Using Spore-Formers Microogranisms
The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, on Sept. 7, which provides recommendations that allow for greater flexibility when manufacturing biological products with
spore-formers. The guidance finalizes a draft guidance issued Feb. 24, 2005, and addresses revised regulations that went into
effect June 1, 2004.
Under the revised regulation, FDA no longer requires the use of permanently dedicated buildings and equipment for spore-formers,
if certain controls and precautions are applied. "We recognize that advances in facility, system, equipment design, testing,
and sterilization technologies have increased the ability of manufacturers to control and analyze the manufacture of biological
products," FDA specified in the guidance. "[We] found that manufacturers could evaluate aspects of a biological product's
safety and purity with testing. The use of appropriate procedural controls, validated processes, and enhanced testing capability
provides the manufacturer with a degree of confidence that their biological product achieves the expected levels of safety
and purity. Areas of special concern, such as process containment, contamination with pathogenic and/or toxic agents, sterilization,
and disinfection can be addressed using currently available procedures and processes." FDA also said that it encourages alternatives
to spore-forming microorganisms for producing future biological products. These alternatives include using sporulation-deficient
strains or recombinant proteins expressed in nonspore-forming microorganisms.