Ohio Health Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Serving Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Parma, Youngstown, Canton, and Lorain OH

Chris Fleming posted an interesting article on the Health Affairs Blog this week entitled "PHARMA: McClellan Predicts Resurgence of Rx Drug Access Concerns."  Fleming begins the article by discussing the Senate's passage of the Food and Drug Administration Revitalization Act sponsored by Ted Kennedy and Michael Enzi.  According to Enzi's press release, "the bill establishes a system of active surveillance for drugs already on the market, and explicitly gives the FDA new authority through Risk Evaluation and Mitigation Strategies (REMS) to respond quickly and appropriately when previously unknown risks arise."

In the article, Fleming details remarks given by former CMS administrator and head of the FDA Mark McClellan at the National Press Club.  According to Fleming, McClellan called the bill "the biggest set of changes in post-market drug regulations since at least 1962."  McClellan described the so-called tug of war between access to drugs on the one hand and safety concerns on the other.  While, given the Vioxx debacle, the focus has shifted to safety, soon attention will shift back to access concerns, McClellan predicted.

Indeed, McClellan has rightfully portrayed the tension between market access and drug safety.  On the one hand, it is of the utmost importance that life saving drugs make their way to the market as quickly as possible, and on the other, the devastating losses suffered when a drug goes terribly awry, causing life altering or ending side effects, are often difficult to justify.  Interestingly, at the same time that the Vioxx litigation presses on, the Abigail Alliance case proceeded forward in effort to get the courts to determine that terminally ill patients have a constitutional right to potentially life saving treatments, treatments that may in fact neither be safe nor effective.  In both cases, the FDA is criticized. 

Knowledge is power, but sometimes we all have to make decisions when a life is at stake and we have less than the most desireable information available.  When my mother was diagnosed with breast cancer, she opted to take Herceptin, a relatively new biotech drug manufactured by Genentech.  The drug was not FDA approved for women with early stage breast cancer at the time.  I read every clinical trial available, drilled her oncologist with questions about safety and efficacy of the drug and conducted a risk/benefit analysis.  At the end of the day, however, I found that, when you find yourself fighting an aggressive disease and the science places you in an area that's terribly gray, you're more likely to roll the dice.  Perhaps the simple answer is that both the delays to market entry and drug safety ought to be evaluated in light of the severity of the illness at issue. 

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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.

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Last week, the FDA responded to the Institute of Medicine's 2006 report entitled "The Future of Drug Safety:  Promoting and Protecting the Health of the Public."  In the FDA's press release, the FDA noted plans to increase drug safety by taking actions in support of the following (as taken directly from the press release):

• Strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management;
  
  
  • FDA initiatives include developing new scientific approaches to detecting, understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.

• Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and

• FDA initiatives include the establishment of an advisory committee to provide input to improve the agency's risk communication policies and practices, conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.

• Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

• FDA initiatives include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER's organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.

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 According to 42 C.F.R. section 423.504(b)(4)(vi), prescription drug plan sponsors approved to provide Part D benefits must have compliance plans that articulate (1) commitment to comply with applicable laws; (2) designation of a compliance officer and committee; (3) effective training and education of employees and agents; (4) effective lines of communication between the compliance officer and the employees and agents; (5) the enforcement of standards through publicized disciplinary guidelines; (6) procedures for audits and internal monitoring; (7) the procedures for ensuring prompt response to detect offenses and development of corrective action; and (8) a comprehensive plan to prevent and detect fraud and abuse, which includes procedures to voluntarily self report fraud or misconduct.  The OIG undertook a review of stand-alone prescription drug plan sponsors' compliance plans to determine compliance with these eight elements, along with the seventeen requirements set forth in CMS's Prescription Drug Benefit Manual. 

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