Science and Technology in Congress November 2012 Articles Post-Election Questions Remain Among Fiscal Cliff Negotiations Meningitis Outbreak Leaves Congress Questioning Government Oversight of Compounding Pharmacies Proposal to Create U.S. Weather Commission Regular Features Congress In Brief Agency Updates Reports and Publications AAAS News and Notes Frontiers in Science
About the Newsletter Editors Science and Technology in Congress is a newsletter produced by the AAAS Office of Government Relations to provide timely, objective information to Congress on current science and technology issues. To Subscribe: Please send an e-mail with the subject line "Subscribe," your name and address to congress_center@aaas.org. Joanne Padron Carney, Director, OGR Erin Heath, Associate Director, OGR

Post-Election Questions Remain Amid Fiscal Cliff Negotiations

With the election over, all eyes in Washington returned earlier this month to the looming fiscal cliff – spending cuts and tax increases amounting to hundreds of billions of dollars in budget adjustments, and which could reduce federal R&D by as much as $57.5 billion over the next five years. Anyone looking to the November 6 elections for a clear signal on how Congress may proceed was likely disappointed, as it was unclear how much the election changed, with Republicans maintaining control over the House and the Democrats remaining in control of the Senate and the White House. Before the election, the overriding question had been the parties’ willingness to compromise on taxes, entitlements, and discretionary spending, and that is the key question still.

The current state of affairs appears murky, to be sure. On the one hand, there have been some recent signals that the rhetoric may be easing. Immediately after the election, House Speaker John Boehner (R-OH) signaled a renewed willingness to work with the President on a deal – a sentiment echoed by the President – and said the Republicans could accept changes in existing deductions and loopholes to raise revenue. Perhaps even more notably, some Republican legislators have signaled a willingness to break with a key anti-tax group over the Thanksgiving recess, when Sens. Lindsey Graham (SC), Bob Corker (TN) and Saxby Chambliss (GA), and Rep. Peter King (NY), separately said they would be willing to raise taxes in some form to reach a deal. These statements break with the common anti-tax pledge sponsored by Americans for Tax Reform, and may be seen as presenting some political risk.

But more recently, the negotiations have hit what Boehner referred to as a “stalemate.” The Administration’s initial proposal – circulated by Republican aides – took a hard line on both taxes and entitlement spending, with increased tax revenues accounting for the majority of deficit reduction in the President’s plan. The proposal was criticized quickly by Boehner, a day after Senate Minority Leader Mitch McConnell (R-KY) levied his own criticisms of Democratic plans to raise taxes on the wealthy. And for their part, Democrats also appear increasingly unwilling to accept major cuts to entitlements, which have been a big driver of spending over the past few decades.

There is also the question of timing: legislators are exploring the option of reaching a short-term deal on taxes and spending to delay the cliff, thus giving Congress more time to achieve a broader deal. But even then, there are disputes over whether entitlements should be included in any temporary measure. Further complicating the picture is the looming debt ceiling once again. Recently the Treasury Department said the United States will likely reach the current borrowing limit of $16.4 trillion by the end of 2012. The department said it would employ "extraordinary measures" to buy additional time, extending the situation into early 2013. Similar steps were taken last year to give Congress time to negotiate the previous debt-ceiling deal. That deal, reached in August 2011, added more than $2 trillion to the federal borrowing limit and put in place the sequestration. The approaching debt ceiling adds another ticking-clock element to ongoing negotiations to delay or avoid the sequestration. According to Congressional Budget Office estimates, the federal debt stands at roughly three-quarters of the annual gross domestic product (GDP).

Congress could include another debt-ceiling increase in any deal on the fiscal cliff – but there is disagreement over this move, as is the case in every other aspect of this debate. Indeed, compromise rhetoric aside, the potential for a deal remains murky, leading Erskine Bowles, the co-chair of the President's Bowles-Simpson commission, to predict the nation will ultimately go over the fiscal cliff.

-- Matt Hourihan

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Meningitis Outbreak Leaves Congress Questioning Government Oversight of Compounding Pharmacies

This fall over 14,000 patients in 23 different states were exposed to a rare form of fungal meningitis through contaminated steroid injections. As of the writing of this article, of those exposed, 510 cases of patients with meningitis have been identified in 19 states, resulting in 36 deaths. Serious questions remain over gaps between state and federal regulatory oversight, as well as the legal definition of compounding pharmacies and drug manufacturers.

In September clinicians at the Tennessee Department of Health (TDH) confirmed several cases of unexplained fungal meningitis and notified the Centers for Disease Control and Prevention (CDC). A subsequent investigation by TDH, CDC, and the Food and Drug Administration (FDA) identified that contaminated steroid injections from the New England Compounding Center (NECC) in Massachusetts were responsible. NECC recalled the contaminated drugs, and in October was investigated by FDA and the Massachusetts Board of Pharmacy (MBP). These investigations revealed numerous regulatory infractions, inadequate sterilization procedures, and vials of steroid injections containing visible black particulate matter (later confirmed as microbial contamination). CDC then activated its Emergency Operations Center to contact potentially exposed patients, monitor diagnosis and treatments, and provide up-to-date information on the outbreak. NECC recalled all products currently in circulation, permanently surrendered pharmaceutical licenses for the facility and for its three primary pharmacists.

Both the House Committee on Energy and Commerce (E&C) and the Senate Committee on Health, Education, Labor, and Pensions (HELP) held hearings to investigate the actions and responsibilities of all actors. Testifying before the committees were Joy Lovelace, a wife of a victim of the outbreak; NECC President Barry Cadden; FDA Commissioner Margaret Hamburg; MBP Commissioner Lauren Smith; CDC National Center for Emerging and Zoonotic Diseases Director Beth Bell; TDH Director Marion Kainer; International Academy of Compounding Pharmacies CEO David Miller; and American Society of Health-System Pharmacists Vice President Kasey Thompson. Both E&C and HELP commended TDH and CDC for their response to the outbreak. Bell highlighted the importance of federally-funded programs that trained clinicians “on the ground” and provided laboratory and surveillance capacity in preparation for such an outbreak. Meanwhile MBP and FDA faced questions about their regulatory oversight of NECC since its inception in 1998. Cadden declined to answer questions, invoking his 5th Amendment Constitutional rights.

As discussed at the hearings, in the 14 years NECC was in operation, FDA conducted three series of inspections (each relating to a separate complaint or incident), issued two reports of objectionable conditions, and issued a formal Warning Letter for numerous violations of pharmaceutical regulations. MBP investigated a dozen additional complaints, issued four advisory letters and reprimands, and entered into a consent agreement with NECC to resolve numerous problems relating to misfilling of prescriptions and problems with drug potency and sterility that had previously led to patient infections. In July 2002, two patients in New York were hospitalized with meningitis-like symptoms after receiving steroid injections from NECC contaminated with bacteria. Subsequent inspections by FDA again identified problems with drug potency and sterility at NECC, leading FDA to recommend that MBP prohibit NECC from drug development until these problems were resolved. FDA warned there was “potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.” But NECC continued its operations.

Much of the discussion at both the E&C and HELP hearings focused on two major factors underlying the outbreak: 1) the definition of a compounding pharmacy versus a drug manufacturer; and 2) the regulatory oversight of both FDA and MBP. In her testimony, Hamburg defined traditional pharmacy compounding as “the combining or altering of ingredients by a licensed pharmacist...produc[ing] a medication tailored to that patient’s special medical needs.” This can include reformulating a drug to accommodate patient allergies, or altering dosage and suspension for children or the elderly. All parties involved in the hearings, including members of Congress, cited the benefits of this practice. While FDA maintains heavy oversight over drug manufacturing, Hamburg cited a lack of policy guidelines on pharmacy compounding. She said that Section 503A of the Food and Drug Administration Modernization Act (FDAMA) of 1997 exempts compounding drugs from several provisions of FDA regulation, which have been challenged in court with conflicting results, and leave FDA with ambiguous oversight. In such situations, FDA defers to state-level regulators whose oversight is more clearly defined. Hamburg proposed a tiered system of regulation that separates traditional compounding (which requires minimal oversight) from non-traditional compounding, and clearly defines state and federal regulation in each category. Several members of both E&C and HELP challenged Hamburg’s perspective, arguing that repeated inspections, reports, and especially the 2006 Warning Letter indicate that FDA believed it could exercise regulatory oversight over NECC, and questioned why FDA had not continued to do so. Hamburg responded that FDA authority was “limited, unclear, and contested.” In her testimony, MBP Commissioner Lauren Smith stated that MBP had “primary responsibility for oversight” and that “troubling questions remain” about MBP investigations of NECC.

 HELP has requested input from all 50 state boards of pharmacy on the balance between federal and state regulation of compounding pharmacies and has drafted a proposal for legislation to improve drug distribution security.

-- Laci Gerhart

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Proposal to Create U.S. Weather Commission

The University Corporation for Atmospheric Research (UCAR) and The Weather Coalition sponsored a congressional briefing, “Toward a U.S. Weather Commission: Protecting Lives, Livelihoods, and the American Economy,” during which, a panel of experts called on Congress to create a U.S. Weather Commission to protect the American people from economic and personal harm.

The panel included John Armstrong, chair of the Committee on the Assessment of the National Weather Service Modernization Program; William B. Gail, co-founder and chief technology officer of the Global Weather Corporation; Pamela G. Emch, senior staff engineer and scientist for Northrop Grumman Aerospace Systems; and Thomas Bogdan, president of the University Corporation for Atmospheric Research. Scott Rayder, senior advisor to the UCAR president, moderated the event.

The briefing was held in response to the National Academies (NAS) report, Weather Services for the Nation: Becoming Second to None. The committee that authored the report pointed out that the National Weather Service has not changed its operations or structure since its last modernization in the 1990s. The report contains three core recommendations for the National Weather Service: prioritize core capabilities, evaluate the organization’s structure and function, and improve collaboration with all parts of the weather enterprise, including the private sector.

According to the expert panel, normal weather events cost our country $485 billion per year, and major storms in 2011 alone resulted in another $52 billion in damages, 8,000 injuries, and over 1,000 fatalities. A National Weather Commission would provide guidance to policymakers as they implement the NAS committee’s recommendations, to ensure that scientists have the resources they need to improve forecasting capabilities and warning systems.

UCAR and The Weather Coalition suggested that Congress model the new Commission after the U.S. Commission on Ocean Policy, a largely successful advisory panel that provided guidance on ocean policy issues to President Bush from 2001-2004.

--Sara Spizzirri

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