Introduction:
Successful navigation of the regulatory maze is a
prerequisite for companies using biomarkers and diagnostics to advance
personalized medicine. U.S., European, and Japanese regulators recognize the
critical role they play and are reaching out to the industry by publishing
guidance and requesting commentary. Additionally, recent legislation, such as
GINA, is giving companies new opportunities to further their efforts in
personalized medicine. However, plenty of barriers still exist: some are
intrinsic to regulatory processes, while others relate to the interpretation of
regulations. Industry players are exploring a variety of approaches to overcome
these challenges.
Questions Answered in This Report:
*
A host of regulatory decisions and deadlines are occurring right
now.
How will GINA (signed into law in May 2008) influence clinical trial
enrollment and purchasing of personal genetics products once it fully takes
effect in November 2009? What impact will the imminent final report on gene
patents by the SACGHS have on licensing practices and patient access to genetic
tests? What will the results of the Navigenics/Mayo Clinic study on predictive
genetic risk assessments reveal when the study completes in December 2009? What
will be the outcome of the August 2009 announcement by the EMEA to clarify
criteria used to evaluate in vivo diagnostic tests, taking effect on February
1, 2010? How will Japan’s PMDA adhere to the action plan it set forth in April
2009 to enable shorter review times of diagnostics?
*
The ACLU has filed a suit against Myriad Genetics regarding
Myriad’s
BRCA gene patents.
How is Myriad responding to the lawsuit?
What are the implications of this litigation? Why is there so much controversy
surrounding gene patenting?
*
In July 2009, the FDA amended the drug labels for Amgen’s
Vectibix (panitumumab) and ImClone/Bristol-Myers Squibb/Merck KGaA’s Erbitux
(cetuximab) to incorporate
KRAS testing prior to determining treatment
for colorectal cancer.
What value do regulators place on genetic data? What
other moves has the FDA made recently related to biomarker requirements and
recommendations? What regulations has the EMEA instituted on this
front?
*
Debate surrounding the use, regulation, and marketability of
personal genetic tests is heating up.
Who is benefiting from personal
genetic tests? How should these tests be regulated? Which agency currently has
oversight of these tests? What are the different ways in which these tests
marketed?
*
Europe has identified more pharmacogenomic markers than the
United States or Japan.
For how many drugs does the EMEA support
pharmacogenomic testing? What is Japan’s position on pharmacogenomic testing
and on reviewing these data?Scope:
Regulatory processes: PMA, 510(k), CE marking, CLIA
certification.
Agencies: FDA, EMEA, PDMA, AdvaMed, CDER, CBER, CDRH,
PMC, CDC, USPTO, and ACLU.
Markets: United States, Europe, and Japan.
Relevant issues and key legislations to watch: gene
patenting, comparative effectiveness research, DTC genetic profiling services,
CLIA, GINA, Genomics and Personalized Medicine Act.