Spring is springing. Daffodils are blooming inside the Beltway! We are already getting ready for Cherry Blossom Season, which is set to peak March 27 – April 3. Daylight Saving Time is this weekend and soon the daylight hours will be longer and I will no doubt be in a better mood. And meanwhile, here is a bit of what happened this week respecting our realm:
- Washington Post Editorial on FDA Funding – The Washington Post editorial page (the same people, by the way, who supported the decision to invade Iraq) ran a rather scalding editorial called "Fix the FDA". The editors link the problems with the Heparin directly to the lack of funding for FDA to be inspecting foreign plants. While one may suppose that is true, they give no evidence that it is, in fact, a lack of funding that caused the problems with Heparin. They may have a point. They may not. But I would add that funding, without leadership, will probably not solve the problems.
- Dr. von Eschenbach Makes a Speech! – Finally. Speaking of FDA leadership, the speech was actually delivered February 29, but the FDA posted a notice about it this week on the home page of the FDA’s Web site. The speech was called "FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World" and in it, he calls for a re-creation of the FDA. He does a nice job of establishing the fact that the rapid changes that are occurring in food and medicine present specific challenges for the agency, but he falls way short in communicating a plan on how to rehabilitate the agency, or even to acknowledge the serious problems that the agency itself is having while trying to meet the new challenges. It is a speech he should have given two and a half years ago when he assumed his position. He did not lay out the problems and state how he is going to address them. Instead he dashed off a few actions he views as agency accomplishments and then called for stronger food enforcement laws. The speech we need to hear now is not about why we need the FDA to change, but how he is going to do the job.
- Research Paper on Fast Track and Priority Review Programs – The Congressional Research Service, a research arm of the Congress, produced a new paper called FDA Fast Track and Priority Review Programs that analyzes the FDA track record and policies on Accelerated Approval, Fast Track and Priority Review. People so often confuse these areas that in addition to providing analysis of the agency track record, it is an excellent training tool. Check it out.
That’s it for me this week. It has been a tough one! Hope you all have a good weekend.