Programs: Science and Policy
Science and Technology in Congress
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
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
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.
Congress In Brief
Quick status reports to keep you up to date on recent S&T bills and hearings.
Reps. Randy Hultgren (R-IL) and Chaka Fattah (D-PA) introduced H.R. 815, which declares 2013 the "Year of the Federal Lab," and highlights the accomplishments of national energy laboratories and over 100 other labs that function as federal research centers.
On November 27 the President signed the Whistleblower Protection Enhancement Act (S.743). The bill protects government employees from retaliation when disclosing evidence of gross mismanagement, gross waste of funds, or abuse of authority within the government. Of interest to the research community, the legislation includes language that protects against censorship related to research including efforts “to distort, misrepresent, or suppress research, analysis, or technical information” (further background here).
Senate Majority Leader Harry Reid (D-NV) recently stated that “a bill that was and is most important to national security was just killed...cybersecurity is dead for this Congress.” Republican leadership opposed the bill largely because Reid would not allow an open amendment process (more detail here and here). The Senate also failed to pass cybersecurity legislation in August. At that time Republicans were concerned that mandatory security standards in the bill would put unnecessary burdens on the private sector.
On Nov. 12 the Congressional Budget Office (CBO) released an analysis of the cost to implement the Great Ape Protection and Cost Savings Act (S. 810). The legislation would prohibit invasive research on great apes, require permanent retirement for those animals that are currently being utilized in research, and expand an existing sanctuary to house them in retirement. According to CBO, it would cost the federal government $56 million over a four-year period (report summary here; full report here).
Francis Collins, director of the National Institutes of Health, announced on Nov. 16 that he has decided not to move forward with a recommendation from NIH’s Scientific Management Review Board that NIH establish a new institute focused on substance use, abuse, and addiction-related research. As such, the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will retain their institutional identities. Collins was initially favorable about the idea and formed an internal task force to recommend how a merger of the two institutes could best be accomplished, but in the recent statement he said he “concluded that it is more appropriate for NIH to pursue functional integration, rather than major structural reorganization, to advance substance use, abuse, and addiction-related research.”
On Nov. 20, the FDA issued a draft Guidance for Institutional Review Boards related to clinical research in the Federal Register. The draft Guidance “is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed." Public comments are due January 22, 2013, and a copy of the draft, along with a link to submit comments electronically, can be accessed here.
The Departments of Commerce and Labor have announced a new initiative, the Make it in America Challenge, which will provide $40 million in competitive grant funding to accelerate the trend of in-sourcing, whereby companies bring jobs back to the U.S. and make additional investments here. The competition will be opened through a Federal Funding Opportunity to be announced by the start of 2013. It will focus on projects that accelerate job creation by encouraging in-sourcing of productive activity by U.S. firms, fostering increased foreign direct investment, incentivizing U.S. companies to keep or expand their businesses in the U.S., and training local workers to meet the needs of those businesses.
On October 5, the Animal and Plant Health Inspection Service (APHIS) and the Centers for Disease Control and Prevention (CDC) published the final regulatory rule to govern the utilization of select agents and toxins. The final rule implements a tiered system for regulating select agents based on risk for misuse and danger to public health; for example, 11 agents have been designated as Tier 1 agents and thus will require additional security measures. The agencies removed a number of other agents and viruses from the select agent list. In addition, the rule mandates stricter inventory requirements and audit procedures to enhance security. The rule goes into effect on December 4, 2012. In related news, the Centers for Disease Control and Prevention (CDC) has issued a request for information and comments in the Federal Register on whether to list the highly pathogenic avian influenza (HPAI) H5N1 from the Goose/Guangdong/1/96 lineage as a Tier 1 select agent. The research surrounding the synthetically derived HPAI/H5N1 strain created an international debate over whether to publish the research results, due to concerns that the information could be utilized by bioterrorists. Public comments are due on or before Dec. 17.
- Carbon Tax: Deficit Reduction and Other Considerations
- Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine
- Federal Support for Academic Research
- Oil and Gas: Information on Shale Resources, Development, and Environmental and Public Health Risks
- Energy-Water Nexus: Coordinated Federal Approach Needed to Better Manage Energy and Water Tradeoffs
- Health Information Technology: CMS Took Steps to Improve Its Beneficiary Eligibility Verification System.
- Responsible Conduct in the Global Research Enterprise
- Climate and Social Stress: Implications for Security Analysis
Satellite Task Force: A Review of NOAA’s Future Satellite Program: A Way Forward
The final Grand Challenges Lecture Series event has been rescheduled for December 10, 2012. Click here for details. View the video from our Food-Energy-Water Nexus panel and the video from our Biosecurity Panel.
Hot topic: The fiscal cliff. Check out the video from the AAAS briefing on sequestration, or view presentations from Matt Hourihan (AAAS) and Orlando Auciello (Argonne National Laboratory). Find sequestration resources on our new webpage.
“Engineers think about formulas and numbers, surgeons work with their hands, physicists focus on explaining materials behavior, and biologists analyze complex cellular interactions. They all work in biomaterials, but they often speak different languages and have different priorities. For biomaterials to move from the lab to clinical use, these groups increasingly need to work together. With this in mind, Science and Science Translational Medicine are covering the basic, the applied, and everything in between—the so-called translational space.”
Read the special issue of Science on biomaterials.