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The FDA as a Public Health Agency

By, Margaret A. Hamburg, M.D., and Joshua M. Sharfstein, M.D.

A little more than a century ago, concerned about the potential dangers of food preservatives such as formaldehyde, Congress passed, and President Theodore Roosevelt signed, the Pure Food and Drug Act.

 The act sought to prevent the "manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors." The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture.

Pink Sheet- House Comparativeness Effectiveness Bill includes “Physician Out” Clause

By Cathy Kelly, A group of moderate House Democrats introduced legislation on Comparative Effectiveness Research May 19th that includes new language aimed specifically at limiting the influence of CER on physician prescribing.

Introduced by Rep. Kurt Schrader, Ore., the bill is modeled on the comparative effectiveness legislation introduced in the last Congress by Sens. Max Baucus, D- Mont., and Kent Conrad, D- N.D.  

NCI- Comparative Effectiveness Research Stirs Excitement as Well as Debate

By, Carmen Phillips. It doesn’t take a randomized clinical trial, the joke goes, to prove that it’s unwise to leap from an airplane without a parachute. However, randomized clinical trials have been vital in helping clinicians make informed choices about patient care, whether in treating advanced colorectal cancer or controlling high blood pressure.

Associated Press- Nominee to Lead FDA Confirmed By Senate

The Senate yesterday confirmed President Obama's pick to oversee food and drug safety, areas that are vital to consumers and are widely seen as critically needing improvement.

  Margaret Hamburg, a bioterrorism expert, will be sworn in as the 21st commissioner of the Food and Drug Administration. She is the second woman to hold the post in 100 years of agency history. The Senate confirmed her nomination by voice vote.

Hamburg's first priority will be to help direct development of a vaccine for the new swine flu. She has said she also wants to revamp food safety.

Wall Street Journal- Health Costs Are the Real Deficit Threat

By Peter R. Orszag, This week confirmed two important facts -- that health-care costs are the key to our fiscal future, and that even doctors and hospitals agree that substantial efficiency improvements are possible in how medicine is practiced.

The Pink Sheet- Senate Adding Safeguards Against Direct Link Between Comparative Effectiveness Research, Coverage Decisions

By Ramsey Baghdadi, Senate Finance Committee Chairman Max Baucus, D-Mont., plans to propose patient protections for federal comparative effectiveness research

that draw a clear line separating information gathering and coverage decisions.

The "pro-patient safeguards," as they're being called, would take the next step after previous Baucus statements that seek to distance comparative effectiveness from insurance coverage decisions, according to Finance Committee staffer Shawn Bishop.

NPR: Orszag: Health Coalition's Plan A 'Significant' Step

White House budget director Peter Orszag said Tuesday that a plan by health care industry stakeholders to cut projected costs increases from 2010-'19 is a significant step.

Orszag discussed the 2010 budget at a meeting last week.

Washington Post- Senators Offer Their Support to F.D.A. Nominee

By Gardiner Harris, The Obama administration’s choice to lead the Food and Drug Administration breezed through her Senate confirmation hearing on Thursday while the administration proposed a budget that would give the agency more money

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Wall Street Journal- Obama Wants Additional $300 Million for FDA

By Jared A. Favole and Alicia Mundy, President Barack Obama wants Congress to give the Food and Drug Administration an additional $300 million in its budget, which the agency called the largest funding boost in its history.

AACI, AACR, ASCO, and Friends host Hill Day 2009, and Honor Senator Arlen Specter

“Investing in the Future of Cancer Research” More than 50 cancer center representatives from 20 states descended upon Washington, DC, on Wednesday, May 6th, to educate the nation's policymakers about the importance of a strong federal commitment to cancer research.

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