From the Hill – Winter 2013

House, Senate Committees investigate meningitis outbreak

After a meningitis outbreak this fall tied to a Massachusetts compounding pharmacy, House and Senate committees held hearings to investigate what happened, and members on both committees clashed with Food and Drug Administration (FDA) Commissioner Margaret Hamburg over whether the FDA could have done more to prevent the outbreak.

More than 14,000 patients in 23 states were exposed to a rare form of fungal meningitis through contaminated steroid injections. As of December 12, 2012, 590 cases had been identified in 19 states, resulting in 37 deaths.

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 the TDH, CDC, and FDA determined that the New England Compounding Center (NECC) in Massachusetts was responsible for the contaminated injections. A subsequent investigation by the FDA and the Massachusetts Board of Pharmacy (MBP) found numerous regulatory infractions, inadequate sterilization procedures, and vials of steroid injections containing visible black particulate matter (later confirmed as microbial contamination). The 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 and permanently surrendered pharmaceutical licenses for the facility and its three primary pharmacists.

At the hearings held by the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, members commended the TDH and the CDC for their responses to the outbreak. Beth Bell, director of the CDC’s National Center for Emerging and Zoonotic Diseases, discussed the importance of federally funded programs that trained clinicians on the ground and provided laboratory and surveillance capacity in preparation for such outbreaks. But members questioned whether the MBP and FDA provided adequate regulatory oversight of NECC.

As discussed at the hearings, in the 14 years that NECC had been in operation, the FDA conducted three series of inspections (each related to a separate complaint or incident), issued two reports of objectionable conditions, and issued a formal warning letter for numerous violations of pharmaceutical regulations. The MBP investigated a dozen additional complaints, issued four advisory letters and reprimands, and entered into a consent agreement with NECC to resolve numerous problems related to the misfiling 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 the FDA again identified problems with drug potency and sterility at NECC, leading the FDA to recommend that the MBP prohibit NECC from drug development until these problems were resolved. The FDA warned that 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 the House and Senate hearings focused on two factors underlying the outbreak: the definition of a compounding pharmacy versus a drug manufacturer and the regulatory oversight of the FDA and MBP.

“From the Hill” is adapted from the newsletter Science and Technology in Congress, published by the Office of Government Relations of the American Association for the Advancement of Science (www.aaas.org) in Washington, DC.

In her testimony, Hamburg defined traditional pharmacy compounding as the combining or altering of ingredients by a licensed pharmacist producing a medication tailored to a patient’s special medical needs. This can include reformulating a drug to accommodate patient allergies or altering dosage for children or the elderly. All parties involved in the hearings, including members of Congress, cited the benefits of this practice. Although the 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 of 1997 exempts compounding drugs from several provisions of FDA regulation, which have been challenged in court with conflicting results and leave the FDA with ambiguous oversight. In such situations, the 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 nontraditional compounding, and clearly defines state and federal regulation in each category.

Several members of the committees challenged Hamburg’s perspective, arguing that repeated inspections, reports, and especially the 2006 warning letter indicate that the FDA believed it could exercise regulatory oversight over NECC, and they questioned why the 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 the MBP had “primary responsibility for oversight” and that “troubling questions remain” about MBP investigations of NECC.

The House Committee 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.

U.S. Weather Commission proposed

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 (NWS) Modernization Program; William B. Gail, cofounder 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 UCAR.

The briefing was held in response to the National Academies report Weather Services for the Nation: Becoming Second to None. The committee that authored the report pointed out that the NWS has not changed its operations or structure since its last modernization in the 1990s. The report contains three core recommendations for the 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 the United States $485 billion per year, and major storms in 2011 alone resulted in another $52 billion in damages, 8,000 injuries, and more than 1,000 fatalities. A U.S. Weather Commission would provide guidance to policymakers as they implement the Academies 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.

Federal science and technology in brief

• 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 United States 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 insourcing of productive activity by U.S. firms, fostering increased foreign direct investment, giving U.S. companies incentives to keep or expand their businesses in the United States, and training local workers to meet the needs of those businesses.
• On November 27, the president signed the Whistleblower Protection Enhancement Act, which 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.”
• An effort to pass cybersecurity legislation failed, after Republican leaders objected because Senate Majority Leader Harry Reid (D-NV) would not allow an open amendment process. 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 November 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 animals that are currently being used in research, and expand an existing sanctuary to house them in retirement. According to the CBO, it would cost the federal government $56 million over a four-year period.
• Francis Collins, director of the NIH, announced on November 16 that he has decided not to move forward with a recommendation from NIH’s Scientific Management Review Board that the agency establish a new institute focused on substance use, abuse, and addiction-related research. Thus, the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism will retain their institutional identities. Collins 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.”
• 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 more than 100 other labs that function as federal research centers.
• On October 5, the Animal and Plant Health Inspection Service (APHIS) and the CDC published the final regulatory rule to govern the use of select agents and toxins. The 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 went into effect on December 4, 2012.