When Oversight Becomes Overburdening

By Pejman Yousefzadeh Posted in | Comments (4) / Email this page » / Leave a comment »

A strong case for unshackling the invisible hand at the FDA:

THE notorious red tape at a government agency like America's Food and Drug Administration (FDA) is, in the words of Milton Friedman, "a consequence of its constitution in precisely the same way that a meow is related to the constitution of a cat." Friedman often argued that the agency's heavy-handed, over-cautious approach to drug approval did more harm than good by stifling innovation and delaying the arrival of life-saving new medicines on the market.

Few are likely to agree with his conclusion that the FDA is unreformable and must be abolished outright--therein lies a tort lawyer's paradise. But signs that the industry is beginning to shift away from a few blockbuster drugs towards a larger number of products targeted at less common diseases or particular patient groups (see article) strengthens the argument for lightening the regulatory burden and shifting the balance away from guarding public safety and towards encouraging innovation.

Read it all. The article makes the persuasive--and common sense--point that the increased wait times for new drugs to be approved and the huge amounts of regulation that now surround the approval process conspire to cause pharmaceutical companies to submit fewer drugs for FDA approval. This disincentive regarding innovation is bad for the financial health of pharmaceutical companies, of course. It is also going to be exceedingly bad for the health of the people who depend on these companies for drugs that will either save their lives or make them more comfortable.

Regulation was designed to protect us. It is, instead, slowly sapping us of our health. If that's not enough incentive to take action against the overweening nature of the regulatory state, I don't know what is.

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I just finished listening to an audio book by John Stossel where he made the exact same point. So if the FDA studies a drug for 7 years and on the 7th year it is approved, there is always a big press conference where they announce how many lives will now be saved. well, doesn't that mean in the previous 7 years, they essentially killed people by keeping the drug off the market?

slow, slower, and stop. How can you expect people to work at a steady pace for a minor thing like pharmaceuticals and day dream about their retirement at the same time?

"a man's admiration for absolute government is proportinate to the contempt he feels for those around him". Tocqueville

in government like to believe that all government employees sit around daydreaming, but it isn't really true at the professional levels. I'm not saying that the bad image isn't true, only that it isn't universally true. Much of the blue/gray collar work is either heavily unionized, patronage, or both, so productivity isn't what they're aiming for. The "front counter" work, the part most of you see, is mostly the product of anti-discrimination laws. Governments, like most large organizations with deep pockets, essentially scrapped their "minimum qualifications" for entry and low-level positions to avoid disparate impact suits. The MQ for most of those jobs is "fogs a mirror," and you just try to get rid of the really bad ones in their probationary period while not getting sued. This fact, and the generally declining work ethic among younger workers, is the reason for the slugs at DMV counters and such places.

At the professional level, you don't work as hard as an independent small business person or a private practice professional - I've done both, but you do a day's work for a day's pay. Most government offices are 90-10 organizations: 10% of the employees do 90% of the work - at least the meaningful work. What really slows down government work is the Godawful outdated organizational structures, the multiple levels of review and supervision, and the minimal (or non-existent) competence of politically appointed management.

I'll give you an example from my days at the technical professional level. Let's say somebody somewhere had identified some issue that they wanted addressed and it (or the requestor) was important enough that it required a decision by political management to do it. I would often get tasked with the Briefing Memo on something like that. I know my business and had a good eye and ear for the politics of things, so I could crank something coherent out in anywhere from a few hours to at most a few days if it took some research. I'd send it in draft to the Section Chief and we'd go back and forth until it was something the SC could sign off on and send to the Division Director. It would go back and forth between the DD, the SC, and me until it was something the DD could sigh off on. Then it would go to some Deputy Commissioner and the process would repeat itself until it was something the DC could sign off on and send to the Commissioner. If it was something that had to go to the Governor, the process would repeat itself until it was something the Commissioner would sign off on. Bear in mind this was what it took to just make a decision on whether we should do anything at all. If we decided that we needed to do something, I'd get tasked to write a Decision Memo that laid out all the options (at least all that I wanted to offer them) and the Pros and Cons of each option. Here's where the Devil lives in the process because every one of those Pros and Cons is a CYA, a Gotcha, or an "I told you so." Then the process would repeat itself through all those levels of review. Then, if you actually did something, at the first squawk from a contributor or the first bad press, everybody in the process was eating carpet, showing the Boss how you'd considered that eventuality, and, blame fairly fixed on he who had the least to do with it, the whole direction would change, and you'd start over. Then if it was a big enough deal and took long enough to go over an election cycle, you got a whole new crop of appointees who threw out everything you'd done for the prior administration and usually tried to throw you out with them. Bear in mind that my government was much flatter and more centralized than the Fed, so multiply the levels by several orders in the Fed.

Private enterprise rather painfully over the last couple of decades has dramatically flattened its organzational structures. Government is still stuck in the hierarchal structures of seventy-five years ago. I've written often here about what that restructuring might look like so that a government could actually be run be Republicans and actually get something done, so I'm not going to rehash it. I'll just close by saying that there really isn't much anyone could do to speed up government processes under current structures and with so many levels of politically appointed or politically ambitious management.
In Vino Veritas

Right now Drug companies can go through years of the approval process and if something comes up that neither the Drug company nor the FDA anticipated the Drug company is open to lawsuits. Why not open things up, if the drug companies want to go through 7 years of the approval process make their products immune from lawsuits. If they don't go through the approval process they are open to suits. If they eventually get approval they are once again immune.

In general I would love to have a patient pays malpractice/liability system. Here are your drugs, if you want to be able to sue for damages if there is an adverse reaction, pay this $20 charge on top of the $5 cost of the drugs. If you chose not to pay the premium you agree to indemnify the manufacturer (or Doctor) against damages.

It will never pass but a guy can dream.

 
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