FDA Matters Blog

Archive for the ‘FDA Appropriations’ Category

FDA: A Bargain at Two Cents Per Day Per American

Sunday, March 28th, 2010

FDA touches every American many times each day. Today’s investment (2 cents per day per American) is a pittance compared to the benefit of a strong FDA and the risk of an underfunded FDA. There cannot be many agencies in the US government that have such a vast scope of responsibilities and so few dollars to get the job done.

This is the powerful message that the Alliance for a Stronger FDA has been delivering to Capitol Hill. Even still, it will be a difficult year for any federal agency whose mission and responsibilities are growing. (more…)

FDA Needs at Least a $250 Million Increase in FY 2011

Sunday, March 7th, 2010

The President’s proposal to freeze domestic discretionary programs in FY 2011 (and beyond) will force painful cuts across government and in programs that millions of American rely upon. Even some traditionally-favored agencies, such as NIH, are looking at only small increases. With a proposed 6% increase (about $150 million), FDA would seem to be doing far better than most.

FDA Matters feels strongly that this is not nearly enough. By my calculations, at least a $250 million increase for FDA would be needed, just to achieve the program levels anticipated in the President’s budget request. The Alliance for a Stronger FDA has asked for a $495 million increase, which could be put to good use by the agency. Why is 6% not enough? (more…)

The President’s Budget Request: Is 6% Enough for FDA?

Thursday, February 4th, 2010

The President’s FY 11 budget request for FDA includes a $146 million increase in appropriated (non-user fee) funding. This is about 6% of the $2.36 billion appropriation that FDA received in FY 10. With the President’s tough talk about deficit reduction, anything above a freeze should be considered good. Why was the Alliance for a Stronger FDA disappointed? (more…)

FDA, SOTU, and the President’s Budget Request

Thursday, January 28th, 2010

The President’s State of the Union (SOTU) address gave no clues as to the fate of the FDA budget for FY 11 (begins October 1, 2010). Both the general and specific details for the agency await the February 1 release of the President’s budget request.

While the House and Senate have control over the final amount that FDA receives, the President’s request is the baseline against which the Congress works. FDA Matters is pleased to offer a guide to interpreting this first stage of the FY 11 appropriations process. (more…)

Mr. Brown Goes to Washington

Sunday, January 24th, 2010

The election of Massachusetts’ new Senator, Scott Brown, has set off a media frenzy about the fate of health care reform legislation. However, the ramifications of his election reach far beyond health reform.

FDA turns out to be a good example. FDA Matters sees at least three consequences of his election that may affect the agency in 2010. (more…)

Can FDA Withstand the FY 11 Budget-Cutters?

Sunday, December 6th, 2009

Tradition says nothing happens between Thanksgiving and New Year’s Day.  People check out mentally and, as often as possible, physically. Not this December, not in Washington, DC.

Most attention is on the US Senate, which is working this weekend and remains under threat of “no days off” until healthcare reform legislation passes. Just as intensely, but much less visibly, the Executive Branch is working full-tilt to complete the President’s Budget Request for FY 11 prior to the State of the Union speech in late January.

Of the two December activities, the President’s budget is far more important to FDA. (more…)

To Whom Much is Given, Much is Expected

Tuesday, October 6th, 2009

There is good news to report now that House-Senate conferees have finalized work on FDA’s FY 10 budget. FDA received $306 million (15%) more to spend this fiscal year. Every center will have more resources to work with (see table at the bottom of this article).

This is the third good year for FDA, after years of bad ones. The agency is still severely underfunded, but progress is finally being made. Now the hard work begins: spending the new money wisely and showing that it has been used to accomplish important public health missions. (more…)

It’s Time to Change CDER Funding

Thursday, September 17th, 2009

I did some crunching of FDA budget numbers for my column earlier this week on the Office of Regulatory Affairs (ORA). A by-product of my efforts was an analysis of how the Center for Drug Evaluation and Research (CDER) is funded.

As most readers know, bio-pharma companies pay user fees, based on activities (such as submitting a New Drug Application) and on the number of their manufacturing facilities. The amounts are set by law. As part of the arrangement, FDA agrees to certain performance goals, which are also specified in law.

We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired. (more…)

After Kennedy, Who Will Lead the Senate HELP Committee?

Sunday, August 30th, 2009

We mourn the passing of Senator Kennedy. He had something others admire, but can rarely duplicate. He was–often simultaneously—a formidable ideologue and the first to create a bipartisan bridge over troubled Senate waters. The health reform debate has suffered greatly from the absence of his commanding personality and his sense of how to make a deal (and make it stick).

Sadly, we are already involved in the game of guessing who will be the new chairman of the Senate Health, Education, Labor and Pension (HELP) Committee. I have also started to think about the possible impact on the FDA. (more…)

A Busy Year for FDA Legislation

Sunday, August 9th, 2009

With Congress on August recess, it is time to review and comment upon this year’s FDA-related legislation, which seems more far-reaching than usual. Matched with an activist agenda from FDA’s new leadership team, this could be a watershed year for the FDA. (more…)

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