FDA News Roundup

The FDA was in the news a lot this week, an especially noticeable series of events if you have multiple searches returning FDA news each day as I have.  Reviewing my Twitter feed alone (follow me!), I linked to six separate news items about the FDA the last four days:

• Feb 11 - FDA to contract out more foreign inspections from FiercePharma
• Feb 11 - An evidence-free and detail-light op-ed in The Hill's Congress Blog written by Newt Gingrich*, GOP 2012 presidential hopeful; Andrew C. von Eschenbach, former FDA commissioner appointed by Bush 41; and Wayne Oliver, former Georgia Pharmacy Association lobbyist and current head of Gingrich's Center for Health Transformation, a "think-tank" for health care and FDA reform.
• Feb 10 - An op-ed by Rep Joe Pitts (R-PA) claiming that the new proposed FDA medical device regulations are driving innovation and jobs to the EU.
• Feb 10 - FiercePharma again, this time linking to an NYTimes op-ed by Ian D. Spatz, former Merck exec, writing about how direct-to-consumer ads are an important public educational tool that can reduce side effects.
• Feb 9 - a press release from the House Appropriations committee with proposed budget cuts of $220M from FDA's budget for 2011, around 7% of its requested $3.2B in 2010.
• Feb 9 - A Wall Street Journal article noting FDA's concern over six different companies not completing their follow up commitment studies they promised to conduct following accelerated approval of their products.

Bringing all these stories together into some sort of context I leave to others.  One does note that the "over-regulation is hurting business" meme was in heavy rotation this week.

*Newt has been after the FDA for a long time.  In 1994 as Speaker of the House, he advocated "nuking" the FDA altogether and replacing it with a combination of third party reviewers and corporate tax incentives. (Authentic Leadership: Rediscovering the Secrets to Creating Lasting Value, William W. George; Jossey-Bass, 2003)