Archive for the ‘FDA Accountability and Transparency’ Category
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…)
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Posted in Drug Approval and Access, FDA Accountability and Transparency, FDA Leadership, FDA and Congress, FDA and Industry, FDA-NIH Relations, Follow-on Biologics, Food Issues, Orphan Drugs | No Comments »
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…)
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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…)
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Posted in Drug Approval and Access, FDA Accountability and Transparency, FDA Leadership | 1 Comment »
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…)
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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…)
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Posted in FDA Accountability and Transparency, FDA Leadership, FDA and Congress, FDA and Industry, Insight on FDA-regulated Industries | No Comments »
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…)
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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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Posted in Drug Approval and Access, FDA Accountability and Transparency, FDA Leadership | 1 Comment »
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…)
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Posted in FDA Accountability and Transparency, FDA Leadership, FDA and Congress, FDA and Industry | 1 Comment »
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…)
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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…)
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