Thanks, Professor Hyman, for 3 comments in 3 days! Perhaps I missed something but I did not see any constructive criticism or concrete proposals from you on how to improve the current situation in your comments or in your MDDI article. As a former resident of “Ivory Towers,” I thought teachers should not simply criticize the doers when they fail but also guide them on how to learn from mistakes they made, as well as those made by others.

And the non(or not yet)-removal pain and suffering is dealt with at the doctor’s office, not the hospital.

But I’m concerned at the thought of any agency free from political interference. The 510k program was a badly needed creation imposed by Congress due to industry insistence that reigned in an arrogant FDA, which cares not what it costs or how long it takes to bring new products to market, nor the harm that results from artificially high barriers to entry.

The Federal Reserve and Consumer Financial Protection Bureau are poster children for the case against “independence.” We can thank the Fed for single handedly creating the investment environment that wrecked our economy and led to an unprecedented bailout of bankers gone astray (Wall Street gamblers should have lost all, to teach them a lasting lesson–the Main Street banking system would have survived the resulting carnage just fine). And the CFPB is yet another government agency captured by its biggest customers, the too-big-to-fail banks who shouldn’t be allowed to exist in the first place. It’s taking political pressure in a Republican administration to for some badly needed push back.

Federal agencies are an arm of the executive branch. They are not, nor should they be, a fourth branch of government. Being stocked by progressives (as opposed to liberals or conservatives), they expand, by their very nature, into every reach of the citizenry, and thereby smother individualism and the natural emergence of a healthy economy that Hayek first observed.

Yes, government has an important role to play. Human greed is want to play outside the boundaries. My point is simply that an unfettered FDA is likely to cause more harm than good.

Again, greatly enjoyed your comments. Well done!

Wayne: What you said about the current FDA Commissioner is exactly what I am worried about. Indeed, most leaders of federal agencies are appointed by the President and, thus, are called “political appointees.” Call me naïve if you wish but I don’t think once appointed these agency leaders need to or should allow the President and other elected officials interfere with the internal processes of their respective agencies. Being “public servants,” their primary duty is to serve the public and fulfill the agency’s mission and not to be subservient to the President or his/her political party. An example of such “independent” agency is the Federal Reserve. Its decisions do not have to be ratified by the President or anyone in the Executive Branch even though its chair is nominated by the President. The Fed is not free from accountability because it is subject to oversight by Congress, with the duty to submit semi-annual reports.

Hi Binseng, as usual you provide additional insightful comments. As you know all US Government agencies are inherently political by definition. By way of example, the Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services with more than 14,000 employees and an annual budget of more than $5B. The commissioner is appointed by the president of the United States with the advice and consent of the Senate.I had the opportunity to meet the current Commissioner, Dr. Gottlieb recently at a MITA Board of Directors meeting and I can assure you he is political. So, given that the FDA is inherently political, as are all Government Agencies, your hope/wish that the FDA be free from “political interference” is not possible. I wish I had a good answer for you regarding a proposed solution, all I can say is that we must all collectively become part of the process that is, not what we might like it to be (almost certainly whatever you or I would propose would be objected to by someone else anyway!). Therefore in the absence of the magic bullet that would make the Agency free from politics we must continue to nudge the process, through the political process, toward a more equitable and accountable direction. One way to do this might be eliminating the funding component of the Agency that comes from the OEMs – MDUFA. Thanks for bringing up this topic!

Perhaps I did not express myself clear enough. By “more independent,” I meant “free from political interference.” A good example is the issue of device servicing. After asking the Congress to force FDA to issue a report, MITA said it is unhappy with it and wants Congress to take further actions. Being a rule-of-law country, no one—including the President—is above the law, so FDA must be accountable for its actions too. However, as I said, no one should expect it to be perfect either. FDA must also learn from its own mistakes and take corrective and preventive actions in the continual improvement process we all should adopt. One initiative that FDA is taking is the Case for Quality. Let’s give it a chance to prove whether it will be better than the traditional inspection process. Wayne: since you are clearly more experienced and wiser than me, what is your proposed solution?