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Policy News

FDA leadership promotes scientific integrity, quality standards

October 1, 2009

FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.

Global health concerns generate new therapies for home and abroad

September 1, 2009

Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.

Healthcare reform to shape drug coverage, costs, and R&D

August 18, 2009

With healthcare-reform legislation moving forward, insurers, providers, and pharmaceutical companies are keeping a sharp eye on policy proposals likely to affect coverage, costs, and benefits. Various constituencies in the healthcare community are supporting initiatives that will increase access to healthcare and make the nation's costly healthcare system more efficient and effective.

FDA leaders stress safety, transparency in drug development

July 20, 2009

An important component in protecting public health, according to Margaret Hamburg, new commissioner of FDA, is to ensure access to innovative, safe, and effective medical products.

FDA gains resources for strengthening product safety

June 1, 2009

FDA is stepping up oversight and enforcement activity for medical products as part of its efforts to demonstrate a vigorous approach to ensuring food and drug safety.

Comparative effectiveness research may shape treatment, coverage decisions

May 1, 2009

The economic stimulus package approved by Congress in February provides more than $1 billion to support research on competing medical treatments. Although a fairly minor piece of the larger $789 billion American Recovery and Reinvestment Act of 2009 (ARRA), the provision set off widespread reaction to the possibility that comparative study results may be used to limit coverage of more expensive medicines.

Sebelius confirmed as Secretary of HHS

April 29, 2009

Kansas Governor Kathleen Sebelius has been confirmed and sworn in as the next Secretary of the US Department of Health and Human Services (HHS).

Food and drug safety crises prompt White House, congressional action

April 1, 2009

The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.

Debate over follow-on biologic legislation continues

March 12, 2009

At the 2009 annual meeting of the Generic Pharmaceutical Association (GPhA) in February, House Energy and Commerce Committee Chairman Henry Waxman told attendees that a workable scientific, regulatory, and legal pathway for follow-on biologics (also referred to as biogenerics or biosimilar pharmaceuticals) would lead to more affordable medications for Americans.

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