General Discussion
Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsSupreme 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
Laurian
(2,593 posts)If corporations were people, they'd die from unregulated drugs.......
HiPointDem
(20,729 posts)OldDem2012
(3,526 posts)...the five SC Justices who voted to overturn the regulation in 2002.
FiveGoodMen
(20,018 posts)Not even with the simple loss of their jobs.
Swede Atlanta
(3,596 posts)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.
DURHAM D
(32,610 posts)Wish I did.
joeybee12
(56,177 posts)I can't read the whole article...thanks.
former9thward
(32,016 posts)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.
Romulox
(25,960 posts)former9thward
(32,016 posts)Changed the title in edit.
kelliekat44
(7,759 posts)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)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)Rehnquist and Ginsburg join the dissent...
MEDICAL CENTER ET AL. (535 U. S. 357) (2002)
Held: The FDAMAs prohibitions on soliciting prescriptions for, and
advertising, compounded drugs amount to unconstitutional restrictions on commercial speech. Pp. 819
OCONNOR, 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
City Lights
(25,171 posts)The USSC is a disgrace.
glinda
(14,807 posts)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.
Lasher
(27,597 posts)Do they think they're good now?
SoapBox
(18,791 posts)Scalded Nun
(1,236 posts)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)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)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.