Wednesday, April 08, 2009


It's certainly welcome news that the FDA will require new approval for medical devices that were on the market already in 1976 when the law changed to require approval for medical devices and were exempted from approval at that time.  That's long overdue.

The change is of a piece with regulatory practice in a number of contexts.  The FDA itself sometimes requires a drug manufacturer that has received pre-market approval of its drug to conduct post-marketing studies, which can either confirm or cast doubt upon the initial judgment that the drug's benefits outweigh its risks. Likewise, in other specific contexts, the law either expressly requires periodic re-evaluation or regulates via an open-ended standard that itself has room for growth: E.g., a requirement that a device, drug or whatever be "safe and effective" would seem to require an updating of the baseline for both safety and effectiveness as technology improves.  In this way, standards (rather than rules) sometimes automatically function as the sort of "best-practice" requirements that I discussed earlier in the week in my FindLaw column.

Nonetheless, regulation often occurs via fixed rules that have a limited capacity for re-evaluation and even best-practice standards can become dated over the course of a sufficiently long period of time.  Perhaps the best example of these phenomena is the U.S. Constitution, whose essential features are so difficult to change that it operates in many respects like an outdated medical device, one that perhaps was justified many years ago but cannot be judged "safe and effective" today, given the alternatives (such as abolishing the Senate and the Electoral College, limiting Supreme Court tenure to 18 years, and you-name-your-pet-change).

Posted by Mike Dorf


PG said...

I'm guessing some "medical devices" will get waved through quickly.

Sobek said...

Totally off-topic, but you realize that Obama is a bald-faced liar, right? It's one thing to say "I'm so utterly inexperienced at foreign policy and protocol that I routinely piss off our closest allies," but another thing entirely to claim he didn't bow to the Saudi King.

I know you guys pretended to care about honesty when Bush was in office. Is that still an important character trait for an elected official?

PG said...


Which of our closest allies is pissed off? They all seemed pretty happy with him at the G-20 summit (contrast with Bush). Which of our major allies -- or heck, non-allies -- can you name who has expressed displeasure with the change from Bush to Obama?

It's funny because there are real things to worry about the Obama Administration's honesty, like transparency in TARP or budgeting, but you folks are wetting yourselves over whether he's bowed instead of literally hand-holding and face-kissing the Saudis as Bush did.

Sobek said...

How about the Brits? I know, I know, tiny little country and all, with very little influence in the world and not a lot of history with America, but still.

And misspelling the Brazilian President's name? Classy.

" transparency in TARP or budgeting..."

Or promising not to wait five days before signing legislation, or promising to make the full Porkulus on-line before signing it. Okay, so we agree that Obama's promises aren't worth much.

"...but you folks are wetting yourselves over whether he's bowed..."

I didn't care much about the story when it was just about him breaching protocol with a bow (distasteful, sure, but it's just another example of idiocy for the pile). It's the flat out lie, with full knowledge that the media will cover for him, that is so galling.

Sobek said...

Oh, and promising to find middle ground on abortion, before reversing the Mexico City policy, rescinding the conscience rule, and nominating Dawn Johnsen.

Sobek said...

Incidentally, Bush comparisons aren't terribly impressive. Considering you guys think he was the worst President -- if not human being -- in history, saying "at least Obama's better than Bush!" is not terribly impressive.

Especially because I'm not going to defend Bush. He shouldn't have been kissing the king, either.

mvymvy said...

The National Popular Vote bill would guarantee the Presidency to the candidate who receives the most popular votes in all 50 states (and DC).

Every vote would be politically relevant and equal in presidential elections.

The bill would take effect only when enacted, in identical form, by states possessing a majority of the electoral votes--that is, enough electoral votes to elect a President (270 of 538). When the bill comes into effect, all the electoral votes from those states would be awarded to the presidential candidate who receives the most popular votes in all 50 states (and DC).

The Constitution gives every state the power to allocate its electoral votes for president, as well as to change state law on how those votes are awarded.

The bill is currently endorsed by 1,512 state legislators in 48 states.

In Gallup polls since 1944, only about 20% of the public has supported the current system of awarding all of a state's electoral votes to the presidential candidate who receives the most votes in each separate state (with about 70% opposed and about 10% undecided). The recent Washington Post, Kaiser Family Foundation, and Harvard University poll shows 72% support for direct nationwide election of the President. This national result is similar to recent polls in closely divided battleground states: Colorado-- 68%, Iowa --75%, Michigan-- 73%, Missouri-- 70%, New Hampshire-- 69%, Nevada-- 72%, New Mexico-- 76%, North Carolina-- 74%, Ohio-- 70%, Pennsylvania -- 78%, Virginia -- 74%, and Wisconsin -- 71%; in smaller states (3 to 5 electoral votes): Delaware --75%, Maine -- 71%, Nebraska -- 74%, New Hampshire --69%, Nevada -- 72%, New Mexico -- 76%, Rhode Island -- 74%, and Vermont -- 75%; in Southern and border states: Arkansas --80%, Kentucky -- 80%, Mississippi --77%, Missouri -- 70%, North Carolina -- 74%, and Virginia -- 74%; and in other states polled: California -- 70%, Connecticut -- 73% , Massachusetts -- 73%, New York -- 79%, and Washington -- 77%.

The National Popular Vote bill has passed 25 state legislative chambers, including one house in Arkansas, Maine, Michigan, New Mexico, North Carolina, Oregon, and Washington, and both houses in California, Colorado, Hawaii, Illinois, New Jersey, Maryland, Massachusetts, Rhode Island, and Vermont. The bill has been enacted by Hawaii, Illinois, New Jersey, and Maryland. These four states possess 50 electoral votes -- 19% of the 270 necessary to bring the law into effect.


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