Emergency Preparedness

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On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce…

Several Congressional committees have held hearings on various aspects of the ACA, including: A House Oversight Health Care Subcommittee hearing on “Obamacare: Why The Need For Waivers?”; a Senate Finance Committee hearing on “Health Reform: Lessons Learned During the First Year“; a Senate Health, Education, Labor and Pensions Committee hearing examining…

On October 15, 2010, the Health Resources and Services Administration (HRSA) published an interim final rule with request for comments establishing the administrative policies and procedures for the CICP, as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The CICP provides benefits to certain persons who sustain serious physical injuries or…

On August 19, 2010, HHS released a report entitled “The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.” Prepared in response to the H1N1 pandemic flu experience, the HHS report reviews the federal government’s role in producing medical countermeasures — medications, vaccines, equipment and supplies…

This post was written by Paul Sheives.

The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious…

On January 7, 2010, HHS released the National Health Security Strategy, which sets priorities for government and private activities designed to protect the population’s health during a large-scale emergency, such as bioterrorism, pandemics, and natural disasters. The strategy and accompanying interim implementation guide outline 10 objectives to achieve health security, including goals in such areas…

CMS is encouraging hospitals and other health care providers to review a new publication, “Community Pan-Flu Preparedness: A Checklist of Key Legal Issues for Healthcare Providers,” which is the result of a public interest dialogue session convened by the American Health Lawyers Association, the HHS Office of Inspector General, and the U.S. Centers for Disease…

HHS Secretary Michael Leavitt has declared that a public health emergency exists in Louisiana, Texas, Mississippi, and Alabama as a result of Hurricane Gustav. The declaration triggers waivers of certain Medicare, Medicaid, and SCHIP rules in the affected states. In a related development, on September 3, 2008 HHS announced implementation of the “Disaster Case Management”…

On June 3, 2008, HHS announced that it has made available nearly $1.1 billion to continue assisting public health departments, hospitals and other health care organizations respond to public health and medical emergencies resulting from terrorism, pandemic influenza, and other naturally occurring emergencies. In a related development, HHS has released three draft guidance documents.…

HHS is holding a Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop on September 24–26, 2008. This event will provide an open forum for the pharmaceutical and biotechnology industry, first responders, policymakers, public health advocates, and others to discuss the development, acquisition, and distribution of medical countermeasures against chemical, biological, radiological, nuclear, and naturally emerging threats. …