New Combination Products Chief Named. On January 6, 2008, Thinh Nguyen
took over as the new director of the Food and Drug Administration's
("FDA" or "the agency") Office of Combination Products ("OCP"), after 14
years at the Center for Devices and Radiological Health ("CDRH").
Industry leaders are now looking to Nguyen to issue long awaited
proposed rules on good manufacturing practices ("GMP") and adverse event
reporting for combination products. The proposed rule on combination
product GMPs is expected to give the manufacturers of combination
products flexibility in deciding whether to comply with the drug cGMP
regulations or the device quality system regulations ("QSR") to avoid
having to fully implement both. In addition, a concept paper on
cross-labeling, a clear definition of "chemical action," and a new
guidance on contrast agents are expected to be released by OCP in the
coming year. Additional information is available at
www.thegraysheet.com (paid subscription service).

FDA Proposed Rule Would Relax Restrictions on Off-Label Promotion. The
Food and Drug Administration ("FDA" or "the agency") recently proposed a
new guidance that would allow medical device manufacturers to provide
physicians with medical journal articles addressing the off-label uses
of their products. Although companies would have to include prominent
warnings that the uses discussed in the articles are not FDA-approved,
companies would essentially be permitted to promote their products for
off-label uses. Many health care professionals and device industry
leaders are encouraged by this rule and believe that it will contribute
to the practice of medicine by immediately supplying relevant
information about the potential benefits of a certain product to
physicians. However, others are skeptical, suggesting that this new
guidance will create a conflict of interest for companies and may result
in unsafe product use. The agency will be accepting public comments on
the proposed guidance for 60 days. Additional information is available
at www.medicalnewstoday.com/articles/97909.php.

Draft HHS Regulation Offers Discreet Adverse Event Reporting. The
Department of Health and Human Services ("HHS") recently proposed a
regulation implementing the Patient Safety and Quality Improvement Act
of 2005's provisions calling for the creation of patient safety
organizations ("PSO"). PSOs would be certified by HHS, allowing them to
contract with hospitals to confidentially accept patient safety
information. The law, which is intended to provide health care
providers a venue for adverse event reporting without fear of lawsuits
or professional sanctions, would allow voluntary reporting of safety
information to PSOs under a legally binding non-disclosure agreement.
However, the rule specifically lists the U.S. Food and Drug
Administration ("FDA" or "the agency") as an exception to the
confidentiality rules. Public comments are currently being accepted
regarding whether the regulation should also exempt communications to
device and drug companies that rely on such reports to fulfill their FDA
reporting requirements. Additional information is available at
www.thegraysheet.com (paid subscription service).

New Guidance Documents Released. The Food and Drug Administration
("FDA" or "the agency") recently added two new guidance documents to the
Center of Devices and Radiological Health ("CDRH") website. One
describes the agency's expectations for premarket notification
("510(k)") submissions for coronary and carotid embolic protection
devices and is available at
http://www.fda.gov/cdrh/ode/guidance/1658.html. The other is a draft
guidance that sets forth the agency's recommendations for analytical and
clinical performance studies to support premarket submissions for in
vitro diagnostic devices intended for the detection or detection and
differentiation of influenza viruses. This document is available at
http://www.fda.gov/cdrh/oivd/guidance/1638.html.