FDA Matters Blog

Archive for the ‘FDA Accountability and Transparency’ Category

Why Do Some People Dislike FDA?

Thursday, October 15th, 2009

Yesterday, I received separate posts from three organizations that are anti-industry, one of which dislikes FDA and one of which hates FDA. They are not alone in these feelings. There are many groups and individuals who believe that industry and physician professional societies run FDA. I don’t accept their premise or the “facts” from which they launch attacks. (more…)

In Praise of Predictability

Thursday, September 3rd, 2009

FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency’s mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress. (more…)

Hot Town, Summer in the City

Friday, August 21st, 2009

Thirty years ago, Washington closed down every August. The heat and humidity were beastly and Congress was gone. Over the intervening years, DC has become a 12-month town, with August one of the busier times.

For FDA, there has been so much August-action that this column had to fit my analysis of two developments: the appointment of the new tobacco center director; and the reorganization of the Commissioner’s office. (more…)

A Resignation and an Allegation at FDA

Sunday, August 16th, 2009

Several reporters called me last week to ask if I had heard about Dan Schultz’s resignation as head of the Center for Device and Radiological Health (CDRH). Had I also heard about conflict-of-interest (COI) allegations against Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER)? Some of the reporters wanted to connect the two events. They wanted me tell them, pundit-like, what this said about Commissioner Hamburg’s approach to integrity in decisionmaking and to allegations of wrong-doing.

I disappointed them. (more…)

Transparency at FDA: A Work in Progress

Thursday, August 13th, 2009

A mantra of the new Administration is that government needs to be transparent. While the goal is laudable, the scope of the task is often ill-defined and everyone has their own ideas about what transparency means. FDA’s efforts must be viewed as a work in progress that may stretch over years. (more…)

Save the Critical Path—Part 2

Sunday, June 28th, 2009

Transforming FDA into a first-class, 21st-century regulatory agency will not be easy. It requires planning, commitment and a broad vision. Science-based decisionmaking is a central part of the transformation, but it doesn’t just happen by itself. Regulatory science needs to provide the tools, standards and knowledge for FDA to handle an ever-more complex world of science and commerce. (more…)

Many Facets to the Transparency Task Force

Sunday, June 7th, 2009

FDA’s disclosure policies are intended to be a balance between “public right to know” and “company right to protect intellectual property that supports innovations.” As such, every FDA policy has a risk-benefit to society, which evolves over time. Seen in this light, the new FDA task force on agency transparency is a legitimate inquiry. It probably should be repeated every 3 to 5 years.

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