FDA & The 2010 Elections: A GxP Perspectives Editorial

Safe & Effective?

Since the appointment of Dr. Margaret Hamburg as FDA Commissioner FDA has made steady progress in modernizing the Agency. Will the 2010 elections undo that? Steve Grossman reported a few weeks ago in FDA Matters that “deficit hawks” could threaten future FDA funding. That funding provides consumer protection for 25% of the U.S. economy. Think back to the period before Dr. Hamburg’s appointment to the merry-go-round of ineffective FDA Commissioners and Acting Commissioners. The lack of effective leadership in an era of globalized food and drug industries is not the direction to be heading. Early entries into this blog were full of FDA follies. Now commentaries on GxP Perspectives are about the modernization of regulations for adverse event reporting. It has been quite a positive change. Here is an early post on Faulty Device Approvals.

Just Where Should We Cut FDA Funding?

Think of the positive achievements of the past two years. The regulation of tobacco, new food safety initiatives, transparency on past FDA errors, hiring energetic staff who consider FDA’s mission one of public health. Now with deficits continuing to loom, there is talk of making the Bush tax cuts permanent and cutting back on essential consumer safety. Just where do you want to cut? Inspecting imported food? Oversight of clinical trials? Perhaps we should do away with post-market surveillance studies. After all, they didn’t help with Avandia. Now go to your medicine cabinet and take out a bottle, any bottle. Can you tell by looking at the tablet or capsule that the active pharmaceutical ingredient actually works? Is it safe and effective for its intended use? Was it manufactured under good manufacturing practices? If you can’t tell by looking at it then we need a strong FDA. GxP Perspectives isn’t sure the 2010 elections are going to help FDA. Time will tell.

Update: An additional statement from FDA Matters

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