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