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Obama 2012

SCOTUS: Generic Drug Companies Do Not Share Same Responsibility As Big Pharmaceutical Companies

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Filed: AOS (pnd) Country: Canada

#1 - Know your drugs the best you can while taking them. The best thing you can do is keep up to date and make sure you pay attention to health studies released. It's the one that that the FDA can be useful for.

#2 - This whole sue the hell out of drug companies every 5 minutes thing is part of the problem with our health care system and part of the higher cost of things overall. Sure, sue for labels to be correct, but if there's a cash settlement/asking involved, then it's gone too far. You CHOSE to try a new drug that there wasn't much known about. It stands to reason that there are going to be new side effects that didn't appear in initial studies. Not every case study is going to be the same. It's a scientific fallacy really at the end of the day, but it's no fault of the drug company.

#3 - Drugs are bad. Mmmmmmm k?



Is your medication safe?

The Supreme Court ruled Thursday that generic drug companies do not share the same level of responsibility as their brand name counterparts in terms of updating warning labels when significant new risks of taking the products are presented.

It's a decision that Judge Sonia Sotomayor says leads to unfathomable and "absurd consequences" for patients.

The plaintiff in the case, Gladys Mensing, started taking the generic version of an acid reflux medication in 2000, and by 2005 she had developed involuntary muscle movements in her hands and feet and her speech became slurred. She sued the generic drug's manufacturer, claiming the label provided insufficient information about the risks of tardive dyskinesia, the neurological condition she developed.

Studies had shown the drug posed a health risk, but the brand name had not updated the label, and as a result, neither had the generic manufacturers. In 2009 the FDA issued a mandatory black box warning on the brand name drug, noting that the “benefit is thought to outweigh the risk of developing tardive dyskinesia,” when the medication is used for longer than 12 weeks. The labeling on the generic version also changed then.

The Supreme Court ruled that if the generic manufacturers had independently changed their labels, they would have violated the federal requirements that their labels be the same as the corresponding brand-name. Generic manufacturers say reinventing “the costly research and testing FDA required to approve the brand drug” would harm their goal of “making prescription drugs available to as many people as possible at the lowest possible cost.”

According to the American Association for Justice 70% of all prescriptions are filled with generic versions, accounting for about 2.6 billion prescriptions every year. It is calling the Supreme Court's decision a “disastrous outcome for patient safety.”

Judge Sotomayor also expressed concern. In her dissent she states, "If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue."

So what should you do if you’re worried about the safety of your drugs? Experts say there are a few things you can do each time you receive a new prescription.

The National Institute of Health has website called DailyMed where consumers can look up their drug by class and brand name, and find up-to-date information about labeling, package inserts and more.

Dr. Douglas Bremner, a professor of psychiatry and behavioral sciences at Emory University, encourages patients to chat with other patients about their experiences. He recommends checking out Medications.com and Askapatient.com, and read about the experiences others have had with the medication you have been prescribed.


The Great Canadian to Texas Transfer Timeline:

2/22/2010 - I-129F Packet Mailed

2/24/2010 - Packet Delivered to VSC

2/26/2010 - VSC Cashed Filing Fee

3/04/2010 - NOA1 Received!

8/14/2010 - Touched!

10/04/2010 - NOA2 Received!

10/25/2010 - Packet 3 Received!

02/07/2011 - Medical!

03/15/2011 - Interview in Montreal! - Approved!!!

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Filed: Citizen (apr) Country: Ecuador
Do away with the FDA.
Si, man. Most of the major drugstore chains will print very thick information packets about the prescription that one is picking up, and they'll staple it to the bag or stuff it in. They can also ask the pharmacist (or any other pharmacist).

Patients can take matters into their own hands by asking their doctor, as he/she is writing the prescription, "Is this generic version of equal quality to the name-brand?"

Perhaps best of all is to go to a pharmacy in a Mexican border town and get (1) the name-brand medicines themselves, (2) their twins or close relatives that are manufactured either by the major European pharmaceutical companies or the European distributors for the major American pharmaceutical companies, or (3) the generic equivalents, whose quality is overseen by the Mexican pharmaceutical regulatory agency. All, off the shelf. The only difference may be the packaging (blister-packs there vs. bottles here) or a slight variance in the name. The best part is that the pharmacists who speak English (this can depend on which town you're in) are often U.S.-trained and may spend an hour talking with you, answering your questions.

06-04-2007 = TSC stamps postal return-receipt for I-129f.

06-11-2007 = NOA1 date (unknown to me).

07-20-2007 = Phoned Immigration Officer; got WAC#; where's NOA1?

09-25-2007 = Touch (first-ever).

09-28-2007 = NOA1, 23 days after their 45-day promise to send it (grrrr).

10-20 & 11-14-2007 = Phoned ImmOffs; "still pending."

12-11-2007 = 180 days; file is "between workstations, may be early Jan."; touches 12/11 & 12/12.

12-18-2007 = Call; file is with Division 9 ofcr. (bckgrnd check); e-prompt to shake it; touch.

12-19-2007 = NOA2 by e-mail & web, dated 12-18-07 (187 days; 201 per VJ); in mail 12/24/07.

01-09-2008 = File from USCIS to NVC, 1-4-08; NVC creates file, 1/15/08; to consulate 1/16/08.

01-23-2008 = Consulate gets file; outdated Packet 4 mailed to fiancee 1/27/08; rec'd 3/3/08.

04-29-2008 = Fiancee's 4-min. consular interview, 8:30 a.m.; much evidence brought but not allowed to be presented (consul: "More proof! Second interview! Bring your fiance!").

05-05-2008 = Infuriating $12 call to non-English-speaking consulate appointment-setter.

05-06-2008 = Better $12 call to English-speaker; "joint" interview date 6/30/08 (my selection).

06-30-2008 = Stokes Interrogations w/Ecuadorian (not USC); "wait 2 weeks; we'll mail her."

07-2008 = Daily calls to DOS: "currently processing"; 8/05 = Phoned consulate, got Section Chief; wrote him.

08-07-08 = E-mail from consulate, promising to issue visa "as soon as we get her passport" (on 8/12, per DHL).

08-27-08 = Phoned consulate (they "couldn't find" our file); visa DHL'd 8/28; in hand 9/1; through POE on 10/9 with NO hassles(!).

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