Archive for the ‘FDA Leadership’ Category
Sunday, August 8th, 2010
FDA supposedly swings back and forth between emphasizing “expedited approvals of promising therapies” and “extended pre-approval examination of every safety issue.” Current thinking is that FDA is now leaning more toward the safety end of this spectrum.
FDA Matters thinks a lot of this is perceptual. Approval decisions reflect FDA’s honest and relatively clear judgment on medical need, quality of the clinical data, and the risks and benefits of a specific product. Mostly, I can understand FDA’s decisions, even when I don’t agree. Still, there is a lot of tension within FDA and with various stakeholders about approvals versus safety risk. (more…)
Posted in Drug Approval and Access, FDA and Industry, FDA Leadership | No Comments »
Sunday, August 1st, 2010
Several generations of North American trained doctors were taught: if you hear hoofbeats, think horses not zebras. This graphic image reinforced an important aspect of medicine for young physicians seeing mostly severely ill patients in tertiary care hospitals: if an otherwise healthy patient is coughing, it is most likely a bad cold. It is almost certainly not pneumonic plague.
What Congress, FDA, and NIH have learned over the last 30 years is that there are many more medical zebras in the United States than anyone imagined. NIH has catalogued nearly 7,000 rare diseases. More are being discovered all the time. Altogether, it is estimated that 25 to 30 million Americans are affected by rare diseases. (more…)
Posted in Drug Approval and Access, FDA Leadership, Orphan Drugs | No Comments »
Sunday, July 25th, 2010
FDA is working on an approval pathway for bio-similars, re-examining the way medical devices are reviewed, trying to upgrade the quality and speed of generic drug reviews and will soon be evaluating its process for granting accelerated approvals to drugs.
These seemingly unconnected activities all have in common that they are supposed to be abbreviated processes to get new products to patients more quickly without risking safety or quality problems. FDA Matters thinks FDA should articulate its philosophy about how these short-cuts should work and what standards apply in all instances. (more…)
Posted in Drug Approval and Access, FDA and Industry, FDA Leadership | 1 Comment »
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 »
Thursday, June 17th, 2010
It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors. (more…)
Posted in FDA and Industry, FDA Leadership, Insight on FDA-regulated Industries | 1 Comment »
Thursday, May 27th, 2010
May 18 marked one year since Dr. Margaret Hamburg was sworn in as Commissioner of the US Food and Drug Administration. The challenges are great, the torrent of issues is never-ending and most days you can smile but you can’t win. Nonetheless, I think it has been a very good first year for her and for Principal Deputy Commissioner, Dr. Joshua Sharfstein.
It may seem premature to be discussing “the Hamburg legacy.” But you know that she is thinking about it (all commissioners do), so why can’t FDA Matters talk about it? (more…)
Posted in FDA and Congress, FDA and Industry, FDA Appropriations, FDA Leadership, Planning for FDA's Future | No Comments »
Sunday, May 23rd, 2010
FDA Matters is in favor of safe foods and safe medical products. Who isn’t? If you are a consumer, maybe that’s all that matters.
However, being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other. (more…)
Posted in FDA and Industry, FDA Leadership, Food Issues, Planning for FDA's Future | 2 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 »
Sunday, April 25th, 2010
Several times this year, I have been told: FDA’s food activities have been getting most of the new monies at the expense of human drugs (CDER) and biologics (CBER). But is it true that food activities (mostly CFSAN, the Center for Food Science and Applied Nutrition) are receiving preferred treatment?
FDA Matters ran the numbers to see. We conclude that center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions. (more…)
Posted in FDA and Congress, FDA Appropriations, FDA Leadership | No Comments »
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