Envisioning 2.0

While scanning the headlines for interesting healthcare-related stories, I often find little tidbits of information and save them to blog about in the future. In this series, From the Back Pages I post links and commentary on a few of them. This month’s edition is below.

FDA Point-Counterpoint: Over the past few months, I have been writing a lot about the Food and Drug Administration (FDA). My posts on this issue have accelerated as Congress and other bodies, most notably the Institute of Medicine have harshly criticized the FDA and called for change at the agency.

Earlier this week, the Archives of Internal Medicine published an article by physicians who have served on the FDA’s Drug Safety and Risk Management Advisory Committee. In the article, they say that the FDA’s needs to reform its drug safety regulatory activities by:

- Giving the FDA more direct legal authority to pursue violations

- Authorizing the adoption of a conditional drug approval policy, at least for selected drugs

- Providing additional financial resources to support the safety operations

- Mandating a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety

- Requiring broader representation of safety experts on the FDA’s advisory committees.

While the FDA has many critics, it also has its defenders. The Wall Street Journal is one of them. In an editorial published today, the Journal says:

“Allow us to draw attention to an important and undernoticed study, Assessing the Safety and Efficacy of the FDA, published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing ‘the central speed-safety trade-off’ involved in drug approvals — and might even do well to move faster.
The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.”

Commentary: The debate over the FDA’s role in DTC advertising, drug safety monitoring, drug approval and other important areas will only intensify. If Congress changers hands next year (or even if it doesn’t) look to see a lot more action on the Hill focusing on the agency and its future role.

Health Affairs Launches A Blog: Earlier this month, the well-regarded health policy journal, Health Affairs announced that it would be launching a blog. Health Affairs’ move is another indication that the academic world starting to take healthcare blogging seriously.

In one of its early blog posts, Health Affairs focuses on the pharmaceutical industry. Two of the articles/reports it mentions deserve special mention:

- “Research and Development in the Pharmaceutical Industry”: In this report, the Congressional Budget Office suggests that the controversial $800 million estimate of the average cost of developing a new drug is justified.

- Focuing on Biotech: In this month’s edition, Health Affairs tackles the biotech industry. One article worth reading is “The Market For Follow-On Biologics: How Will It Evolve?” It focuses on the issue of follow-on biologics and how they may influence drug prices and the intellectual property associated with these products.

Commentary: It’s a wonderful thing that Health Affairs has entered the blogosphere. I’m looking forward to (hopefully) seeing guest posts by some of my favorite health policy bloggers, including Matthew Holt and Joe Paduda.

Protecting Primary Care for the Underserved: Advocacy group The Opportunity Agenda recently launched a blog focusing on healthcare policy and other issues. In an interesting post, the non-profit focuses on efforts by New York governor George Pataki and the Bush Administration to bolster the state’s failing healthcare system.

According to the New York Times, the $1.5 billion agreement will close “under-used hospitals and improve the economic health of those that remain, and to steer people to cheaper health care alternatives than the ones they use now, like outpatient clinics rather than emergency rooms, and in-home care rather than nursing homes.”

The Opportunity Agenda calls the Times’ characterization “deceptively pleasant” and says that the “funds are likely to be used for ‘acute care rightsizing,’ a euphemistic term for restructuring health services that will result in the loss of primary care services in medically underserved areas of NYC - particularly low-income neighborhoods and communities of color.”

Commentary: Clearly the New York State healthcare system is troubled and righting it will require sacrifices from all segments of the industry in the state. However, policy makers should be cognizant that they ensure that they focus on providing people with much-needed primary care, which will decrease long-term costs and ultimately save lives.

This entry was posted on October 13, 2006 at 10:31 am and is filed under From The Back Pages. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.