August 23, 2006
Rudderless FDA
Y'all think I make this stuff up. Our government is endangering lives by bureaucratically keeping pharmaceutical innovation down. Dr. Henry Miller, a physician and former FDA official, points out in TCS today that the agency has had a confirmed commissioner for only 20 months of the Bush presidency ( I gave kudos to Dr. McClellan in May of 2003).
The acting head is facing a tough challenge in Senate hearings because all of government is really about abortion, and two Democratic Senators have a hold on his nomination. Even if Emily's list is placated, Miller is not excited that nominee Andrew von Eschenbach will champion the necessary reforms.
The lack of leadership makes the agency more risk averse than usual. And Miller reports that the innovation-suppressing is taking its toll.
In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed, with direct and indirect expenses now exceeding $800 million to bring an average drug to market. And the trends are ominous: the length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for a decade.FDA is largely responsible for these worrisome trends. Regulators keep raising the bar for approval, especially for innovative, high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard, and the agency has made it more difficult for badly needed new antibiotics to be licensed. FDA's demands for post-marketing clinical trials have proliferated wildly, and "risk management" plans for newly approved drugs have been punitive and designed more to protect regulators' derrieres than patients.
Nope. Nobody sick out here and in need of new medications. Take your time.
The country -- and ThreeSources -- has focused much attention on whether or not the Federal government should subsidize Embryonic Stem Cell (ESC) research, and it is a valid, political question. At the same time, I wish that half of the effort directed at promoting more Federal $$ to ESC could be directed at the things which truly prevent miracle drugs: FDA bureaucracy and a rapacious tort bar.
Read the whole thing. It seems Europe has a largely private sector system for drug and device approvals. Oh well, they always lead the way in freedom...