Editor’s Note: Should drugmakers and medical device manufacturers be allowed to provide physicians with medical and scientific journal articles concerning uses of their products that have not been approved by the Food and Drug Administration? Recently, the FDA issued draft guidance that would permit this practice with certain regulatory restraints. In the post below, Jerome […]

Editor’s Note: Should drugmakers and medical device manufacturers be allowed to provide physicians with medical and scientific journal articles concerning uses of their products that have not been approved by the Food and Drug Administration? Recently, the FDA issued draft guidance that would permit this practice within certain regulatory restraints. In the post below, Scott […]

Having reviewed the latest report on national health spending in 2006 (Health Affairs, Jan/Feb 2008) from the Centers for Medicare and Medicaid Services (CMS) and Paul Ginsburg’s commentary (“Don’t Break out the Champagne: Continued Slowing of Health Spending Growth Unlikely to Last”), I want to offer a dissenting view. Though I do not have the […]

Full implementation of the new Medicare prescription drug benefit contributed to an 18.7 percent increase in Medicare spending in 2006, the fastest rate of growth since 1981 and double the rise in 2005, the federal government reported today. In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, says the […]

It is perhaps a self-fulfilling prophecy that American problems require uniquely American solutions. As a solution to the lack of outpatient prescription drug coverage for the over 65s and disabled, Medicare Part D is unarguably unique. It’s also expensive, complex and awash with perverse incentives. But it is well established, and efforts to introduce greater […]

Editor’s Note: The following letter from Sen. Sam Brownback (R-KS) was originally published in the September/October 2007 issue of Health Affairs. The letter describes Sen. Brownback’s use of a Health Affairs paper as the basis for his Elimination of Neglected Diseases (END) amendment to the FDA Revitalization Act. President Bush signed a version of the […]

Tuberculosis is being a seen as a greater threat to world health now than at any time in the past half-century. The symbiosis of HIV/AIDS with TB in Africa, along with the emergence of multidrug resistant (MDR-TB) and extensively drug restistant TB (XDR-TB) have only heightened concerns in developing countries. Even in a developed country such […]

Why are consumers encouraged — indeed virtually required — to make choices among Medicare Part D plans, but discouraged from making choices about airbags, and prohibited from choosing to accept higher wages in return for accepting certain health risks in the workplace? Why are physicians and patients allowed to take on the risks associated with […]

Widely cited research suggesting that newer drugs “pay for themselves” is unreliable and should not guide policymakers until more valid research is undertaken, say Yuting Zhang and Stephen Soumerai of Harvard Medical School in a paper in the current issue of Health Affairs.

The readers and authors of the new Health Affairs paper “What’s More Dangerous, Your Aspirin Or Your Car? Thinking Rationally About Drug Risks (And Benefits),” by Joshua Cohen and Peter Neumann [1-week free access], have entered into a lively discussion on assessing the risks versus benefits of the drug Tysabri for patients with multiple sclerosis […]

By an overwhelming 93-1 margin, the Senate today passed the Food and Drug Administration Revitalization Act, sponsored by Senate HELP Committee chair Edward Kennedy (D-MA) and HELP ranking member Michael Enzi (R-WY). In addition to authorizing substantial new resources for the FDA through user fees and appropriations, “the bill establishes a system of active surveillance […]

Amid growing debate about appropriate regulation of drug safety by the Food and Drug Administration (FDA), a new study released today in the journal Health Affairs [subscription required] compares mortality risks posed by drugs to risks related to work, transportation, and recreation.
The mortality risks posed by Vioxx to treat arthritis and Tysabri to treat multiple sclerosis –drugs […]

In the wake of mounting drug safety problems, Congress is considering legislation that would strengthen the Food and Drug Administration’s regulatory authority to assure the safety of medications. Policymakers and the public are debating how to strike the right balance between drug safety oversight, the benefits of bringing new medications to market and ways to […]

It’s not the hottest ticket in town. The Prescription Drug User Fee Act (PDUFA) funds 42 percent of the budget of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research, a large, complex, and indispensable scientific bureaucracy that requires fundamental stability. Since 1992, PDUFA has cut drug approval times in half. Congress […]

The Hamilton Project at the Brookings Institution was founded to advance opportunity and prosperity through broad-based growth, economic security, and effective government. Perhaps no issue is more important in all of these regards than health care.
Today we are releasing three specific proposals to promote affordability and effectiveness in health care. This summer we’ll release several […]

Is the United States on its way to a de facto single-payer system? Over the next decade, U.S. health care spending is expected to double from today’s level, reaching $4.1 trillion, with the U.S. government share projected to reach 50 percent. Federal forecasters report in an article published online today in Health Affairs [2-week free […]

By any measure, heart disease, once manifest by sudden death, has largely joined the ranks of chronic diseases in developed countries that can be managed by drugs and behavior, as several articles in the new January-February issue of Health Affairs devoted to Cardiovascular Disease & Society note. And of all diseases that have been […]

It’s Health Wonk Review week! Oh, and the State of the Union was delivered, too. Even though the deadline for entries to this edition of the best of health policy blogging was 9 am the morning after, many bloggers were already debating the president’s foray into health reform.
The President’s plan. Robert Laszewski on the new Health […]

Democrats prioritized price negotiations on prescription drugs, but in principle, payments to private plans are an equally salient target on the new majority’s Medicare agenda. The Republicans’ Medicare Modernization Act pays Medicare Advantage (MA) plans from about 10 to nearly 20 percent more per beneficiary than the traditional fee-for-service program spends on them. The overpayments […]

In a 2001 campaign at Yale University, students, scientists, and the organization Doctors Without Borders asked Yale to help increase access to the AIDS drug d4t in South Africa. Yale scientists discovered and patented d4t; the university subsequently licensed the drug to Bristol-Myers Squibb, which marketed it for $1,600 per patient per year. Under pressure […]