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Archive for the ‘FDA Appropriations’ Category

The State of the FDA—January 2011

Sunday, January 16th, 2011

FDA’s touches the lives of every American at least 6 to 10 times each day. The agency oversees 80% of the nation’s food supply, all of human/animal medical products and cosmetics, and almost all radiation-emitting devices. Altogether, the agency is responsible for about 20% of all consumer dollars spent in the United States.

With the President set to deliver his State of the Union address to Congress in 10 days, it seemed a good time for FDA Matters to provide its view of the "State of the FDA." At the beginning of 2011, the agency is doing well, but has a lot of catching-up to do and faces a number of threats. (more…)

Will the New Congress Be Good for FDA-Regulated Industries?

Sunday, December 19th, 2010


FDA Matters is hearing that FDA-regulated industries will benefit from the 2010 election. It is assumed that a Republican-led House and more Republicans in the Senate will benefit drug, device and food companies. After all, aren’t Republicans more business-friendly and more concerned about perceived regulatory excess?

Those saying and thinking these things may be in for a rude awakening. Even worse, they may find themselves nostalgic for the "good old days" (whenever those were). Everybody—FDA, industry, patients and consumers—is going to have a rough time over the next two years. Industry will be heard more often, but not always have the winning position. (more…)

FDA Funding and the Appropriations Drama

Sunday, November 28th, 2010

The process for passing appropriations bills should be similar from one year to the next. After all, it is a one-directional, regimented process. It always starts with "total available funds" and a baseline of current spending programs and concludes when the President signs an appropriations bill into law. And there are only 12 such bills that have to pass each year.

Yet, I have been through 30 or so appropriations cycles and each one seems to have its own unique story to tell. This year’s efforts would make a riveting "made for television" movie "based on a true story."  FDA Matters doesn’t know how it will end, especially for FDA. (more…)

FDA and Election 2010: Deficit Reduction and Appropriations

Saturday, November 6th, 2010

As a result of the 2010 Mid-Term election, Republicans have netted more than 60 seats and taken control of the House of Representatives, effective in January.  The Senate will remain in Democratic hands, but with a much slimmer majority.

So-called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives.

As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor:  

Regardless of how Democrats, Republicans and the President choose to interact in 2011, there will be a working majority in both House and Senate for significant deficit reduction. (more…)

Deficit Hawks in the New Congress Threaten FDA Funding

Sunday, October 17th, 2010

FDA Matters doesn’t know who the majority party in the House and Senate will be next year. There seem to be a very large number of races where incumbents are vulnerable or are too close to call. The fate of FDA will be driven by the post-election tone of Congress, more than by the fates of individual Members or who holds the majority. (more…)

Success is Uncertain for FDA’s Regulatory Science Initiative

Sunday, October 10th, 2010

FDA Matters was an early advocate for regulatory science. It has been exciting to see the concept grow from the Commissioner’s first public speech to the President’s request for $25 million in FY 2011. And now, FDA has released a White Paper describing the Regulatory Science Initiative (RSI).

It is an excellent report and I applaud those who worked hard to create it. Still, I have misgivings about the way the White Paper characterizes regulatory science, leading to concerns about whether RSI will develop the necessary political and public support to be a long-term, permanent part of FDA. (more…)

FDA Funding for FY 11: Back to the Future

Sunday, October 3rd, 2010

Not so long ago, FDA’s appropriation barely budged from year-to-year. A good year was a 2% to 3% increase. This changed four years ago, after the formation of the Alliance for a Stronger FDA. The agency’s case for more resources—always a good one—finally had an independent, multi-stakeholder voice. Champions on the Hill and in the Executive Branch emerged.

The agency appropriation has grown 50% in the last three fiscal years. So far, FY 11 looks more like the past than it does the last few years. FDA Matters believes that the consequences could be severe. (more…)

Update on FDA’s Appropriation for FY 11

Sunday, July 18th, 2010

On July 1, the House Appropriations Agriculture/FDA Subcommittee marked up it FY 11 bill. The bottomline was good for FDA: $2.571 billion, a $214 million increase over FY 10, about 9%. No further details will be released until the full committee marks up, possibly later this month.

On July 15, the Senate Appropriations Committee marked up its version of the Agriculture/FDA funding bill. The good news is that the Senate agreed that FDA needs better funding….and provided $2.516 billion, a $158 million in new monies. This is a bit more than 6%. Here is FDA Matters’ analysis of this critical budget battle. (more…)

Not Too Soon to Consider the Hamburg Legacy

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…)

Center-Envy: Are Foods Doing Better than Drugs?

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…)

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