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JPZenger

(6,819 posts)
Mon Oct 15, 2012, 01:39 PM Oct 2012

Supreme Ct. Had Overturned FDA's Authority to Regulate Compounding Pharmacies in 5-4 Vote

Last edited Mon Oct 15, 2012, 02:35 PM - Edit history (2)

If anyone has any doubt about the importance of the US Supreme Court and this election, just look at the 15,000 people in 23 states who may have been exposed to meningitis because of a lack of regulation of compounding pharmacies.

These manufacturing operations started out serving local needs, but when they expanded to distribute to multiple states, the FDA felt a need to regulate them. The law authorizing the regulation was overturned by the US Supreme Ct. in a 5-4 decision in 2002.

Much more at:

http://online.wsj.com/article/SB10000872396390444657804578052972230404046.html?mod=googlenews_wsj

The link requires a subscription. If you do your own google search for the article, it will let you read the whole thing for free. It is from 10/15/2012.

Excerpt:

"From 2001 to this year, the International Academy of Compounding Pharmacists spent about $1.1 million on lobbying, according to disclosure reports filed with Congress. In a newsletter to members, the academy described how it defeated a 2007 bipartisan draft bill that would have given the FDA more authority to regulate compounding pharmacies after hundreds of its pharmacists canvassed Capitol Hill urging lawmakers to abandon the proposed legislation.

It isn't known whether tighter regulations would have stopped the outbreak tied to the New England Compounding Center. Lawmakers in that 2007 bill proposed restricting distribution of compounded drugs across state lines, which could have prevented the steroid injections from reaching clinics in 23 states. They also proposed giving the FDA more power to inspect facilities."

NPR also covered this story last week:

http://www.npr.org/blogs/health/2012/10/12/162744871/meningitis-outbreak-puts-doctors-regulators-in-new-territory




20 replies = new reply since forum marked as read
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Supreme Ct. Had Overturned FDA's Authority to Regulate Compounding Pharmacies in 5-4 Vote (Original Post) JPZenger Oct 2012 OP
Another example of SCOTUS valuing corporations rather than promoting the common good. Laurian Oct 2012 #1
kr HiPointDem Oct 2012 #2
Therefore, the current meningitis deaths can be placed squarely on the heads of.... OldDem2012 Oct 2012 #3
And yet they'll never be punished. FiveGoodMen Oct 2012 #5
I would not automatically draw that conclusion........ Swede Atlanta Oct 2012 #18
I can't read it - don't have a subscription. DURHAM D Oct 2012 #4
Who were the 5? The same 5 who installed Bush as an Illegitimate Prez? joeybee12 Oct 2012 #6
No, there were liberals and conservatives on both sides. former9thward Oct 2012 #11
Rehnquist and Ginsburg, who were considered ideological polar opposites, joined in the dissent. nt Romulox Oct 2012 #13
Thanks that is what I meant but my title was poorly written. former9thward Oct 2012 #19
Corporate intersts own the Court. GOP appontees are scum of the earth. kelliekat44 Oct 2012 #7
The division on the SCOTUS is critical life long demo Oct 2012 #8
If this is the right case, there was not a straight ideological division in this case. Romulox Oct 2012 #9
Since corporations are people, this one should be locked up. City Lights Oct 2012 #10
Another fall out from this are pets. People rely upon Compounding glinda Oct 2012 #12
Wingnuts told me activist judges were bad. Lasher Oct 2012 #14
K & R SoapBox Oct 2012 #15
Perhaps I missed something Scalded Nun Oct 2012 #16
Had no idea that compounding pharmacies were involved in this? LeftInTX Oct 2012 #17
That's what they used to be - neighborhood businesses run by a local person JPZenger Oct 2012 #20

Laurian

(2,593 posts)
1. Another example of SCOTUS valuing corporations rather than promoting the common good.
Mon Oct 15, 2012, 01:43 PM
Oct 2012

If corporations were people, they'd die from unregulated drugs.......

OldDem2012

(3,526 posts)
3. Therefore, the current meningitis deaths can be placed squarely on the heads of....
Mon Oct 15, 2012, 01:49 PM
Oct 2012

...the five SC Justices who voted to overturn the regulation in 2002.

 

Swede Atlanta

(3,596 posts)
18. I would not automatically draw that conclusion........
Mon Oct 15, 2012, 04:37 PM
Oct 2012

Without looking at the underlying legislation and the court opinion, one cannot conclude that the SC got it wrong in terms of favoring business interests over those of consumers. Much has to do with the enabling legislation that was passed by Congress and either signed by a President or whose veto was overridden and the regulations that the FDA drafted based on the legislation.

The legislation could be faulty or the FDA could have erred in their interpretation of the enabling legislation and its scope.

I would say, if anything, Congress did not pass legislation sufficiently broad to encompass these pharmacies or the SC got it wrong.

But without more research don't draw that conclusion...i.e. it was the Supreme Court's error. It may not have been.

 

joeybee12

(56,177 posts)
6. Who were the 5? The same 5 who installed Bush as an Illegitimate Prez?
Mon Oct 15, 2012, 02:01 PM
Oct 2012

I can't read the whole article...thanks.

former9thward

(32,016 posts)
11. No, there were liberals and conservatives on both sides.
Mon Oct 15, 2012, 02:26 PM
Oct 2012

Last edited Mon Oct 15, 2012, 04:51 PM - Edit history (1)

Thompson v Western States Medical Center The majority was Justices O'Connor, Souter, Scalia and Kennedy. Justice Thomas filed a concurring opinion. Justice Stephen G. Breyer, joined by Chief Justice William H. Rehnquist and Justices John Paul Stevens and Ruth Bader Ginsburg, filed a dissenting opinion.

 

kelliekat44

(7,759 posts)
7. Corporate intersts own the Court. GOP appontees are scum of the earth.
Mon Oct 15, 2012, 02:04 PM
Oct 2012

I heard the program about these compounding pharmacies the other day. They seem to be the source of the meningitis outbreak from pain meds. I will try to find the link about this.

life long demo

(1,113 posts)
8. The division on the SCOTUS is critical
Mon Oct 15, 2012, 02:05 PM
Oct 2012

We will need a Democratic president together with at the very least a democratic senate from now to at least 2020.

Romulox

(25,960 posts)
9. If this is the right case, there was not a straight ideological division in this case.
Mon Oct 15, 2012, 02:09 PM
Oct 2012

Rehnquist and Ginsburg join the dissent...

THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL. v. WESTERN STATES
MEDICAL CENTER ET AL. (535 U. S. 357) (2002)

Held: The FDAMA’s prohibitions on soliciting prescriptions for, and
advertising, compounded drugs amount to unconstitutional restrictions on commercial speech. Pp. 8–19

O’CONNOR, J., delivered the opinion of the Court, in which SCALIA, KENNEDY, SOUTER, and THOMAS, JJ., joined. THOMAS, J., filed a concurring opinion. BREYER, J., filed a dissenting opinion, in which REHNQUIST, C. J., and STEVENS and GINSBURG, JJ., joined.

http://www.law.cornell.edu/supct/html/01-344.ZS.html

glinda

(14,807 posts)
12. Another fall out from this are pets. People rely upon Compounding
Mon Oct 15, 2012, 02:32 PM
Oct 2012

Pharmacies for "compounded meds" many severe and life threatening diseases their pets may have. These facilities have been life savers for our home. I agree regulation is important and better oversight needed but there is a ton of profit to me made by special interests putting a choke hold on these Companies. It is BIG business in regards to pets.

Scalded Nun

(1,236 posts)
16. Perhaps I missed something
Mon Oct 15, 2012, 04:04 PM
Oct 2012

But once they cross state lines they become interstate commerce, and at that point the federal government gains access. Congress can regulate, and our founding doctrines refer to the general welfare of the population. Big Pharma is as evil as the genetic mutators or our food supply. If you do not keep them on a short lease they will kill us all. Hell, even on a short leash we are in danger.

Our leaders (on both sides) either do not have the balls to do something about it, have been paid off or are too stupid. Any one or a combination fits this bill.

LeftInTX

(25,364 posts)
17. Had no idea that compounding pharmacies were involved in this?
Mon Oct 15, 2012, 04:04 PM
Oct 2012

Last edited Mon Oct 15, 2012, 04:43 PM - Edit history (1)

They normally put together benign type prescriptions such as topicals.....
It's scary

JPZenger

(6,819 posts)
20. That's what they used to be - neighborhood businesses run by a local person
Mon Oct 15, 2012, 07:22 PM
Oct 2012

Sen. Kennedy realized that they had become huge entities, and therefore had become much more dangerous if they screwed up. That is why he got Congress to pass the law during the Clinton Administration.

The news today is that the meningitis is NOT limited to the steriods, and may have infected two other drugs made by the same factory.

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