Juvan's Health Law & Private Equity Report : Corporate & Health Care Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Private Equity, Corporate Governance

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Last week, I attended and presented at the Pharma IQ conference entitled "e-Pedigree and Business Strategies for Drug Supply Security" held in Philadelphia, Pennsylvania.  At the conference, Tim Marsh from Pfizer, Inc. discussed Pfizer's anti-counterfeiting strategies, Dennis Luken, a detective with the Warren county, Ohio drug task force and the National Treasurer of the National Association of Drug Diversion Investigators reviewed the problem of drug diversion and counterfeiting in 2007, while Jim Christian from Novartis AG emphasized that RFID and track and trace technologies are not "solutions" to the counterfeiting problem.  Shay Reid, Vice President from Amerisource Bergen Corp., discussed Amerisource Bergen's attempts to become compliant with California's pedigree laws by 2009, and Robert Drucker from Rx USA Wholesale informed the audience about events that caused him to sue the FDA to prohibit the enforcement of regulations requiring secondary wholesalers to provide pedigrees tracing back to the manufacturer that fail to impose a concomitant obligation on authorized distributors.  Attorney Michael Levine also discussed his involvement in the case and the status of the injunction.  For those of you who are following the case, if you haven't already, I urge you to review the Pharmaceutical Market Access and Drug Safety Act of 2007, which includes language that, if implemented, would require manufacturers and authorized distributors of pharmaceuticals to likewise pass a pedigree.

While I was away in Philadelphia, the following stories made headlines:

• CMS Issues Proposed Decision Memorandum for Medicare National Clinical Trial Policy.  CMS has proposed revisions to its coverage policy for items and services furnished in a clinical trial.  As stated in the press release, the changes would include the following:
  • Renaming the policy as the Clinical Research Policy; 
  • Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
  • Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins;
  • Requiring studies to publish their results;
  • Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the NCD process; and
  • Expanding the “deeming” agencies to all DHHS Agencies, the Veterans Administration, or the Department of Defense.  Deeming agencies are agencies that can “deem” whether a trial has met the general standards outlined in the policy.

See also the Proposed Decision Memorandum, available on the CMS web site.

• Kaiser Family Foundation Reports that Health Care Has Become an Important Campaign Issue.  The Kaiser Family Foundation summarized articles in leading newspapers reporting that health care has become a focus on the 2008 presidential campaign trail.  I would also recommend that readers review the New York Times Article "For Democrats, Health Care is a Rite of Passage."  As the election nears, Juvan's Health Law Update will begin tracking the views of the candidates on both sides of the aisle.