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Emergency Response

July 26, 2011 | Daily News

The full House Energy and Commerce Committee intends to mark up legislation Thursday (July 28) that would reauthorize HHS medical countermeasure programs and mandate more structured coordination between FDA and sponsors of these products, Rep. Joe Pitts (R-PA), chair of the panels health subcommittee, told FDA Week. The Energy and Commerce health subpanel marked up and favorably reported the legislation Tuesday (July 26), slightly modifying the measure via a managers package.

July 25, 2011 | Daily News

The House Energy and Commerce Committee health subpanel will mark-up legislation on Tuesday (July 26) to reauthorize HHS medical countermeasures programs, with the measure already being considered as a major hook for lawmakers' pet issues, including Democrats' attempt to boost funding for FDA's regulatory science program by stripping money from procurement.

July 01, 2011 | Daily News

The House Energy and Commerce Committee is set to consider later this month legislation introduced Wednesday (June 29) to reauthorize HHS medical countermeasure development programs also includes provisions that would expand the role of FDA in the arena and require the agency to prioritize products that protect against chemical and biological attacks, drawing praise from a key biotechnology industry group.

June 27, 2011 | Daily News

Drug industry stakeholders contend FDA lacks comprehensive guidance and has a dearth of expertise on using alternative technologies for influenza vaccines, resulting in hindered development of these products, according to a Government Accountability Office report released Monday (June 27). FDA responded that it intends to strengthen staff expertise, while noting that guidance documents cannot cover all possible scenarios, therefore instead the agency intends to regularly meet with manufacturers.

March 22, 2011 | Daily News

Existing FDA authorities granted through a 2002 bioterrorism law, existing nuclear detection infrastructure and procedures and guidance implemented after the 1986 Chernobyl nuclear accident are enabling FDA to track, identify and isolate cargo from Japan that could be contaminated with radiation in the wake of the tsunami and earthquake that damaged the Fukushima nuclear reactor, agency and industry sources said.

March 17, 2011 | Daily News

Congress has cleared for presidential signature a three-week continuing resolution that would not impact FDA's budget, but would strip $6 billion in spending, including $276 million devoted to pandemic flu preparedness. The CR funds the government through April 8 and cuts HHS programs on state health access grants and appropriations for an HHS building lease in Maryland.

November 24, 2010 | Daily News

FDA is examining whether it needs statutory changes to improve emergency preparedness as part of an HHS medical countermeasures (MCM) initiative, as well as whether alternatives exist to the most common animal testing-based approval pathway for the development of these products, an FDA science adviser said. These activities are part of FDA's MCM action plan, which includes enhancing the review process for MCMs, advancing regulatory science, and optimizing legal, regulatory and policy approaches related to the product's development and use.

October 07, 2010 | Daily News

Sen. Tom Harkin (D-IA) questioned whether FDA has enough resources to properly tackle biodefense countermeasures development and said he plans to examine whether to strip the agency of some of its duties, amid White House efforts to boost some of FDA's biodefense funding and an HHS proposal to enhance the agency's role in the area. In order to enhance the agency's medical countermeasures program, a biosecurity advocate suggested that FDA create a specific center dedicated to addressing the issue, and Harkin expressed some interest in the idea.

October 04, 2010 | Daily News

A key Senate lawmaker chastised HHS last week for its plan to redirect Project Bioshield procurement funds to the Department of Defense and raised concerns that the U.S. is falling behind in developing cell-based vaccine technologies, while agreeing with HHS' aim to strengthen its medical countermeasures enterprise.

September 03, 2010 | Daily News

The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives outlined in an HHS report released last month, according to documents recently sent to Capitol Hill. Stakeholders say they are mixed about the proposal and would have preferred new funding devoted to the MCM initiatives, instead of using appropriations from one countermeasures program to pay for another.

August 28, 2010 | Daily News

A new government plan to bolster medical countermeasures development and availability through conditional licenses, increased mid-pandemic data collection to guide approvals, an emphasis on cell-based vaccine technologies and by bolstering the work of small biotechnology firms could significantly boost the availability and manufacturing speed of therapies to respond to a pandemic, stakeholders said. Nevertheless, sources generally noted that it remains to be seen how HHS and FDA will implement the planned actions, which were released in an HHS report last week.

August 20, 2010 | Daily News

As FDA continues to assess its response to last year's H1N1 pandemic, a top agency official said this week that FDA should examine its approach to foster the development of adaptable technologies. The position is mirrored in a new HHS medical countermeasures enterprise report, which recommends that FDA consider use of new, multi-use manufacturing facilities; develop at least three flu vaccine candidates that don't rely on virus grown in eggs or cells; and lead an HHS-wide effort to review new regulatory and legal approaches for adding products to the stockpile.

July 30, 2010 | Daily News

The Senate is slated to hold a cloture vote Monday on a substitute amendment (SA 4567) to the House Federal Aviation Administration reauthorization bill (HR 1586) that includes funding for a long-sought extension of enhanced Medicaid payments and tweaks the calculation of how drugs are paid for under Medicaid. Sources have said that it is imperative to secure the Medicaid safety net system in order to ensure the insurance expansions mandated by health reform are achievable.

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