FDA Matters Blog

Archive for the ‘FDA Accountability and Transparency’ Category

FDA and Election 2010: Oversight and Investigations

Saturday, November 13th, 2010

The return of a Republican majority in the House of Representatives means an increase in Congressional oversight and investigations. This mirrors 2006, when the Democrats took back Congress and immediately started investigating the Bush administration.

President Obama’s election and the distraction of the health reform debate have helped us forget the impact of divided government on FDA. Once again, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency’s stakeholders. (more…)

All FDA Stakeholders Affected by Medical Device Reforms

Sunday, October 31st, 2010

There are so many visible, contentious FDA issues right now….that reform of the medical device approval process has received only a fraction of the attention it deserves. Other centers at FDA and non-device stakeholders need to be watching more closely. FDA Matters is. (more…)

FDA: A Hit and A Miss

Sunday, September 26th, 2010

FDA Matters has watched FDA handle the Avandia decision differently from any prior controversy. I like the new approach. In the same week, FDA provided a status report on its long-overdue social media and Internet communications policy. Because the agency’s efforts have been glacial, the prospect of useful guidance is dim. I think this is a serious problem. (more…)

Hot Town, Summer in the City—2010

Sunday, July 11th, 2010

For the news media, the only FDA story this coming week will be the two-day advisory committee meeting reviewing the diabetes drug, Avandia. Based on an earlier article (link below), FDA Matters will be looking at how Dr. Hamburg’s FDA handles the discordant voices coming from within the agency.

Missing from public dialogue is the extraordinary (perhaps unprecedented) number of large, consequential projects that FDA will be working on this summer. Every part of FDA is involved in some initiative that could become a “game-changer” for the agency. (more…)

Is the New FDA Different than the Old FDA?

Sunday, June 13th, 2010

Two weeks ago, FDA Matters explored Dr. Hamburg’s legacy, focusing on advocacy for resources, prioritizing regulatory science and upgrading enforcement. These will be accomplished before she leaves office. But is she making similar progress in creating “a new FDA?” (more…)

Dissent and Efficiency: Difficult Trade-offs for FDA

Sunday, May 9th, 2010

FDA has a reputation for being tough on dissent, whether it comes from employees or regulated companies. It is often alleged that FDA employees with contrary views are re-assigned, marginalized or ousted. Within the regulated industries, there is a widespread belief that arguing with FDA has adverse consequences for a company.

Whatever the truth has been in the past, FDA is trying to develop an institutional cultural that welcomes and accepts dissent from employees, industry and other stakeholders. It is difficult, even messy, to do this. Yet, FDA’s reputation and authority rests on showing that it listened to all competing views–without unreasonably slowing the decisionmaking process. (more…)

Fortuitous Timing and Public Health Leadership at FDA

Sunday, March 14th, 2010

At the end of March, Commissioner Hamburg will have been at FDA for 10 months and Dr. Sharfstein for a year. They are very good leaders who have also benefitted from their prior experiences and the timing of their appointments. Here is FDA Matters‘ analysis: (more…)

Shaken to the Core: What FDA and FDA-Regulated Companies Can Learn from Toyota

Thursday, February 25th, 2010

I do not believe that Toyota became a global success by cutting corners and ignoring safety concerns. Nonetheless, the company may not survive the investigations, the lawsuits, the civil and criminal fines, the securities litigation, the recalls (8.5 million cars so far), the loss of consumer confidence and the possible criminal indictments.

FDA Matters hopes that the CEO’s of FDA-regulated companies are paying attention. They need to understand that their company can be “shaken to the core,” as Toyota has. (more…)

Long-term Challenges Need Short-term Attention

Sunday, December 13th, 2009

Most current readers of FDA Matters were not receiving these posts during June, when we examined seven long-term challenges for FDA. Some of these challenges may take years to accomplish; all need to be started now.

We are less than 7 months into the new Commissioner’s tenure. Three or four years from now, she will be judged by whether she moved the agency forward in these areas. I think she has gotten off to a very good start, but there is immense amount of work still required. (more…)

The Perils of Living in a Bubble

Sunday, November 22nd, 2009

This past week, the US Preventive Services Task Force (USPSTF) issued its revised recommendations for breast cancer screening and mammography and set off a firestorm of criticism. Among the controversial items was changing initial mammography screening from 40 to 50 years of age, recommending mammography every two years instead of one, and urging an end to the teaching of breast self-examination.

There is a valuable lesson for FDA in how the announcement and aftermath unfolded. (more…)

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