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 »
Stigmatizing the Obese and Criminalizing Food
January 6th, 2010Well-meaning policymakers are constantly advocating for specific solutions to societal problems. They intend to create a better world and often they do.
In the process, their good purpose is sometimes hijacked by unintended consequences. FDA Matters believes this is the inevitable fate of policies that tell Americans what foods they are allowed to eat. Read the rest of this entry »
Messages to the FDA-Regulated: Seven Columns to Re-read for 2010
January 3rd, 2010This past year has been a tumultuous one for FDA-regulated industries as they struggled to provide new and safer medical products and safer foods, while weathering much criticism.
FDA Matters has explored a number of industry issues in 2009. As they evolve in the new year, I will continue to provide readers with my analysis and commentary. Meantime, here are seven columns that provide insight about FDA-regulated companies. They provide useful background for 2010: Read the rest of this entry »
FDA Leadership and Challenges: Seven Columns to Re-read for 2010
January 3rd, 2010As a rule, FDA Matters does not cover the day-to-day events at FDA and in Congress. Most readers have multiple sources for news about the agency. I doubt I could do better.
Rather, the goal of this blog is to cover larger themes and provide deeper insights into the world of FDA. I place a premium on exploring FDA’s future, as an observer, commentator and instigator. Here are seven columns about FDA leadership and challenges that will help you to better understand the agency in 2010. Read the rest of this entry »
Scientific Reductionism and the End of Medicine
December 27th, 2009“For the last 400 years, science has advanced by reductionism … The idea is that you could understand the world, all of nature, by examining smaller and smaller pieces of it. When assembled, the small pieces would explain the whole.” (John Holland).
Have you ever heard someone accused of “reductionist thinking?” You probably will in 2010 because scientific reductionism is a critical, but rarely articulated, foundation of personalized medicine. Read the rest of this entry »
Off-Label Uses Need to Become On-Label Indications
December 18th, 2009A friend asked: what advice would you give a pharmaceutical company in the late stages of developing a new product that will be widely used off-label? The company’s concern was that FDA might hold the first use to a very high, perhaps unrealistic standard to protect patients that might receive the drug off-label after approval.
In thinking about how FDA views this type of situation, I realized there were two very concrete things the company could do. Here is the FDA Matters analysis: Read the rest of this entry »
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