FDA Needs at Least a $250 Million Increase in FY 2011
March 7th, 2010The 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? Read the rest of this entry »
Shaken to the Core: What FDA and FDA-Regulated Companies Can Learn from Toyota
February 25th, 2010I 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. Read the rest of this entry »
Commissioner Hamburg’s Most Important Personnel Decision
February 21st, 2010With due respect to the many fine individuals that Commissioner Hamburg has recruited, FDA Matters thinks the most important appointment so far has been Michael Taylor to be Deputy Commissioner for Foods. An even more important decision needs to be made soon: choosing the right person to be Associate Commissioner for Regulatory Affairs. Read the rest of this entry »
Transition at PhRMA
February 14th, 2010Former Representative Billy Tauzin tendered his resignation this week, ending a 5 ½ year tenure as President of the Pharmaceutical Research and Manufacturing Association (PhRMA). When his successor is chosen, it will tell us a lot about how the pharmaceutical industry sees itself….and what the big pharmaceutical companies think is their next major challenge. Here is FDA Matters’ analysis. Read the rest of this entry »
FDA’s Growing Presence Outside of the Washington Beltway
February 11th, 2010The federal government is closed for the fourth straight day. However, it would be more accurate to say: closed in the DC area. A significant part of FDA is open and has been all week….making this a good time for FDA Matters to acknowledge and explore the growth of FDA in places far from the Washington Beltway. Read the rest of this entry »
The President’s Budget Request: Is 6% Enough for FDA?
February 4th, 2010The 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? Read the rest of this entry »
FDA, SOTU, and the President’s Budget Request
January 28th, 2010The 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. Read the rest of this entry »
Mr. Brown Goes to Washington
January 24th, 2010The 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. Read the rest of this entry »
A New Food Agency Has Become Unnecessary (For Now)
January 15th, 2010FDA Matters applauds the appointment of Mr. Michael Taylor to be the first Deputy Commissioner for Foods at FDA. With more authority, experience and stature than any previous food leader, he has the opportunity to shape and re-shape food regulation and the safety of the food supply.
Because Mr. Taylor will be outstanding in this new post, the campaign for a separate food agency will go away, at least for a couple of years. Read the rest of this entry »
Has FDA Slipped Back into Anti-industry Mode?
January 13th, 2010An industry CEO wrote me to observe: FDA is returning to the anti-industry paradigm of the past. His concern is understandable. Yet, I respectfully disagreed with him. It is natural to fear change. It is easy to confuse activism with ideology.
FDA Matters believes there are two perspectives from which to judge the situation of FDA versus industry. Read the rest of this entry »
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