In This Issue...


Key House Members Raise Objections to RUO/IUO Draft Guidance

Representative Joseph Pitts (R-PA), Chairman of the House Energy and Commerce Subcommittee on Health and the Vice Chairman, Rep. Michael Burgess (R-TX), wrote to the Food and Drug Administration (FDA) raising strong objections to the agency’s June 1, 2011 “Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.” Excerpts from the March 19 letter are below:

“…The content of the Draft Guidance Document raises several concerns…FDA indicates that ‘actual use’ will now be a factor in FDA’s analysis of ‘intended use’…this addition of ‘actual use’ as a factor in this analysis has significant consequences for not only in vitro diagnostic products labeled ‘for research only’ or ‘for investigational use only’ but also for all FDA-regulated products."

“The Agency appears to further exacerbate this disregard of current law by requiring manufacturers to police end users of their products and halt sales if they know or have reason to know that product use goes beyond research…to comply with the Draft Guidance Document, manufacturers now must conduct surveillance on their customers and stop selling to those customers if the manufacturers know or have reason to know that their customers’ use of the product goes beyond research. Therefore, under this requirement, manufacturers, rather than the FDA, would enforce the FFDCA." (Federal Food, Drug and Cosmetic Act)

“We also have concerns regarding the apparent policy shift giving rise to the Draft Guidance Document. The Draft Guidance Document appears to extend the regulatory reach of the FDA into clinical laboratories, which are currently overseen by the Centers for Medicare and Medicaid Services…the FDA should…focus on its core mission and prevent duplicative efforts by enabling CMS to enforce CLIA.”

The subcommittee members requested agency answers to a series of questions by April 9th. 

OMB Directs Agencies to Streamline Overlapping Rules

On March 20, the Office of Management and Budget (OMB) sent a memorandum to department and agency executives directing them to take into account “the cumulative effects of new and existing rules and to identify opportunities to harmonize and streamline multiple rules.” This directive builds off an earlier executive order issued in January 2011, requiring government agencies to identify and reduce unnecessary regulatory requirements and to consider the costs and benefits of new standards before proposing or adopting them. Under the new directive, agencies are to take a number of steps to reduce cumulative regulatory costs, such as:

  • Use Requests for Information and Advance Notices of Proposed Rulemaking to obtain public input on potentially overlapping rulemakings and on rulemakings that may have significant cumulative effects;
  • Identify opportunities to increase the net benefits of regulations and to reduce the administrative and other costs, while meeting policy goals and legal requirements; and
  • Carefully consider, in the analysis of costs and benefits, the relationship between new regulations and regulations that are already in effect.

This guidance took effect immediately. A copy of the OMB directive is available on the White House Web site.

House Votes to Repeal IPAB

The House of Representatives passed H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, to repeal the Independent Payment Advisory Board (IPAB) created by the 2010 health care reform law. Starting in 2014, the IPAB will be empowered to make cuts to Medicare payments without congressional authorization if certain health care spending limits are exceeded. To offset the costs associated with repealing the measure, the House included medical malpractice reforms, limiting punitive damages and establishing a three-year statute of limitations. The bill passed on a largely partisan vote of 233-181. The White House has promised to veto the legislation if it reaches the President’s desk. The Senate, however, is unlikely to take up this bill in its current format, so it’s also unlikely to reach the President’s desk. A copy of the bill is available on the congressional Web site, THOMAS.

HHS Publishes Additional Rules to Implement HCR

The Department of Health and Human Services (HHS) published two new rules in the March 23rd Federal Register to further implement the 2010 health care reform law. The first, involving the establishment of state-based insurance exchanges (FR pages 17220-17262), gives states more flexibility determining how to comply with many of the requirements, such as certifying health plans and determining the eligibility of a consumer. The second rule (FR pages 17144-17216) addresses the expansion of the Medicaid program with issues related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs. The rule takes effect on January 1, 2014.

Supreme Court Rules in Favor of Mayo Clinic

In a unanimous decision, the Supreme Court ruled in favor of Mayo Collaborative Services/ Mayo Clinic involving a patent infringement claim filed by Prometheus Laboratories. Prometheus alleged Mayo developed an in-house test to measure the metabolite levels of patients taking thiopurine drugs to combat an autoimmune disease. The test permitted a clinician to assess whether the dosage level was toxic or ineffective for the patient. Prometheus asserted that Mayo’s in-house test violated its patents, which identified “correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drugs.” Mayo argued that these correlations were a reflection of natural phenomena and not patentable. The Supreme Court agreed with Mayo stating that: …“to transform an patentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it’.” A copy of the Supreme Court decision is available on its Web site.

House Passes FY’13 Budget Resolution -- With New Budget Cuts

The House of Representatives recently approved a budget resolution for fiscal year (FY) 2013 to cut federal spending by $5.3 trillion over the next decade -- half of which would come from health care. Developed by Budget Committee Chair, Representative Paul Ryan (R-WI), the plan would repeal the core provisions of the 2010 health care reform law that expanded health care coverage, while retaining the $500 billion in cuts to health care providers, including clinical laboratories. In addition, the proposal would convert federal Medicaid payments to a block grant to states, limiting federal contributions to the program, while providing states with greater flexibility in determining how funds are spent, and also, would permit seniors to opt out of Medicare.

In addition, the House plan would eliminate the mandatory two percent across-the-board cut scheduled for January 2013 (required because Congress failed to pass a debt reduction agreement in 2011). Instead, six House committees would be directed to find $261 billion in savings over ten years to offset the required cuts. An analysis of the Ryan proposal, conducted by the bipartisan Congressional Budget Office, warns that “restraints on Medicare spending could lead to reduced access to health care; diminished quality of care for Medicare beneficiaries; greater efficiency of health care delivery; less investment in new, high-cost technologies; or some combination of those outcomes http://www.cbo.gov/publication/43023.”

The White House, along with Senate Democrats, criticized the proposal arguing that it is ‘dead on arrival.’ For a copy of the GOP “Path to Prosperity” plan, please visit the House Budget Committee Web site.

Personalized Medicine Webinar

On April 25th, AACC is sponsoring a webinar, “The FDA and the Advancement of Personalized Medicine,” which will provide an update on ongoing agency efforts in this emerging field.