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House Comm. Seeks Epi Pen Documents, Generic Version Announced

The House Committee on Oversight and Government Reform has requested Mylan CEO Heather Bresch to produce documents and communications about the price increase of Epi Pen.

Mylan today announced it will sell a $300.00 generic version.

Almost every news story has an auto-play video which I won't link to. It's taking more and more time to find articles without video. It is such a waste of time and it really takes a lot of the fun out of blogging.

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    Generic from Mylan (1.00 / 2) (#1)
    by Abdul Abulbul Amir on Tue Aug 30, 2016 at 02:35:40 PM EST
    How interesting.  There are more than a half dozen competitive products available in Europe, but no effective competition in the US.

    Perhaps some of those potential competitors should take a lesson from the Mylan CEO and pony up come cash for the Clinton foundation.

    Apart from your specious ... (none / 0) (#2)
    by Yman on Tue Aug 30, 2016 at 07:47:49 PM EST
    ... slur by implication, you realize that your basic premise is a lie, right?

    Might want to check that kinda thing before you start making silly accusations with no evidence to support them.

    Parent

    Europe (none / 0) (#3)
    by TrevorBolder on Wed Aug 31, 2016 at 04:32:37 PM EST
    has multiple versions of a epinephrine injector, thus a lower price.
    The FDA has had numerous applications in the last 5 years and has kept them jumping through hoops.
    There is one competitor , I believe in the US, but Congress passed a law, if the Dr prescribes Epipen, which most of them do, like Kleenex is for tissues, the pharmacist cannot prescribe the cheaper generic version.

    Parent
    Consumer Reports (none / 0) (#4)
    by TrevorBolder on Wed Aug 31, 2016 at 04:36:18 PM EST
    That's great (none / 0) (#5)
    by Yman on Wed Aug 31, 2016 at 07:38:51 PM EST
    But irrelevant to his slur/specious claims.  Heather Dresch did not donate to the Clinton Foundation and her non-existent donation has nothing to do with the fact that Mylan has a large majority of the US market.

    BTW - All drug and medical device manufacturers have to "jump through hoops".  It's called making sure new drugs and delivery devices are safe and effective.  But the actual reasons that two (as opposed to "numerous") competitors were rejected is because of:  1)  Sanofi's product was recalled because of dosage problems and 2) Teva's generic version in November 2015 and further when Teva's generic competitor was rejected by the FDA in March due to "major deficiencies".

    Parent

    I thought the (none / 0) (#6)
    by TrevorBolder on Wed Aug 31, 2016 at 08:35:40 PM EST
    Basic premise was this
    How interesting.  There are more than a half dozen competitive products available in Europe, but no effective competition in the US.

    So why does europe have 6 choices, and the US only 2?

    Is Europe 's health care system  deficient as to protecting their citizens health,
    Or is just too difficult to get anything approved by the FDA. I understand Mylan is a major major lobbyist in DC

    Parent

    You were replying to my post, right? (none / 0) (#7)
    by Yman on Wed Aug 31, 2016 at 09:29:26 PM EST
    Because my point was very clear, and has nothing to do with your "questions".  But maybe you should research the issue if that's what you're concerned about.  Might help with your false assumptions.

    BTW - All drug manufacturers are major lobbyists, unless you're trying to suggest sone thing more, like Abdul.

    Parent

    I read several articles (none / 0) (#8)
    by TrevorBolder on Thu Sep 01, 2016 at 05:06:08 AM EST
    yesterday regarding this. Many stated that access for American patients is stifled by the FDA,
    the lobbying created the law that Dr's in most states have to prescribe Epipen if that what the Dr writes on the prescription, despite their being  a cheaper generic version.And Dr's write Epipen like people refer to tissues as Kleenex.
    As to the product recalled because of dosage problems, Epipen had the same issues at the same percentages.

    So you are saying that the European health care system is just more cavalier with the health of its citizens then


    Parent

    I have no idea what articles you read (none / 0) (#9)
    by Yman on Thu Sep 01, 2016 at 06:26:00 AM EST
    I don't really care.  Nor do I care about your latest link-free, evidence-free claims.  They're not relevant to my point, which was Abdul's specious/false slurs regarding the Clinton foundation and Mylar's CEO.  So if you decide you want to respond to my post, perhaps you should try to address my point.  Otherwise, I'll continue to ignore your irrelevant claims.

    Parent
    NPR (none / 0) (#10)
    by TrevorBolder on Thu Sep 01, 2016 at 04:06:09 PM EST
    Makes the case, there are many questions, not very convincing answers .
    Big differences in Europe and the USA as far as generic drug options,
    The Epipen just brought the issue to the forefront.
    That was the most important aspect of the post, something which actually affects everyone here.

    The little throwaway line regarding Mylar and the Clinton Foundation probably had its genesis because of their prior history of working together,

    The Clinton Foundation partnered with Mylan at a time when it was raising prices on the EpiPen, which had been distributed by Merck.
    The company partnered in 2009 with the Clinton Foundation to provide a lower-cost alternative for four HIV drugs. Clinton Foundation records show that Mylan has donated between $100,000 and $250,000 to the Foundation.


    Parent
    Not my post (none / 0) (#11)
    by Yman on Thu Sep 01, 2016 at 04:11:41 PM EST
    If you think it was the "most important aspect of the post," respond to the OP.  The most important aspect of my post - the one you responded to - was very clear.   The false accusations and smears against the Clinton Foundation.  It was the focus of Abdul's post and the one I called him on.   Your "throwaway line" about the foundation is no better.

    Parent
    Mylan has a near monopoly (none / 0) (#13)
    by Abdul Abulbul Amir on Fri Sep 02, 2016 at 03:30:28 PM EST

    due to the FDA

    Parent
    They have a "near monopoly" (none / 0) (#19)
    by Yman on Fri Sep 02, 2016 at 07:36:46 PM EST
    ... because the approval process can take a long time and the other companies haven't managed to get their acts together.

    Parent
    They (none / 0) (#20)
    by TrevorBolder on Fri Sep 02, 2016 at 07:56:35 PM EST
    Seem to get it done in Europe though.

    Hmmm, FDA has no jurisdiction in Europe...Do they?

    Parent

    No kidding (none / 0) (#22)
    by Yman on Sat Sep 03, 2016 at 06:31:25 AM EST
    The problem for the drug companies is that they when they make an application for a drug/device in this country, they have to abide by our laws and standards.  

    Hmmmmm ....  If you prefer Europe's laws/standards, you'll need to speak with Congress.  But, hey ... congrats on figuring out the FDA doesn't have jurisdiction in Europe.

    Parent

    The obvious (none / 0) (#23)
    by TrevorBolder on Sat Sep 03, 2016 at 09:16:32 AM EST
    Well, to most of us,

    The goal is to get more and cheaper generics available to the public.

    Europe seems to have done that, without mass deaths occurring from the release of "deadly inferior generics" upon the public.

    And the obvious question, why is the FDA preventing the release of generics in the US.
    Lobbying money having its expected results is a obvious answer,
    Since Europe seems to be getting it done

    Parent

    "Obvious" - heh (none / 0) (#24)
    by Yman on Sat Sep 03, 2016 at 09:25:32 AM EST
    And the obvious question, why is the FDA preventing the release of generics in the US.  Lobbying money having its expected results is a obvious answer, Since Europe seems to be getting it done

    The last resort of someone with no evidence to support their silly smears.  Not to mention those who pretend to speak for "most of us".

    Heh.

    Parent

    Well (none / 0) (#25)
    by TrevorBolder on Sat Sep 03, 2016 at 11:07:21 AM EST
    The last resort of someone with no evidence to support their silly smears.

    Basically the NPR piece I linked to shows that Europe has a infinitely smaller waiting list for generics to get approved than here.
    That is evidence. Yes, it is a obvious question that should be explored. And based on the US system and evidence of successful lobbying in this country, yea, it is a good possibility. Either that or the FDA is just incompetent compared to their European counterparts

    You , on the other hand, have produced nothing to warrant your dismissals.

    Parent

    Don't need to (none / 0) (#26)
    by Yman on Sat Sep 03, 2016 at 10:07:09 PM EST
    I'm not the one pushing laughable, specious CTs about the FDA.

    BTW - The NPR piece doesn't support your silly smears.

    Parent

    Its not a smear (none / 0) (#27)
    by TrevorBolder on Sun Sep 04, 2016 at 06:50:53 AM EST
    If its true.

    The NPR article raises meaningful questions,

    Why can the European continent have multiple alternatives to the Epipen,
    And we cannot process it.
    Is it because Europe is callous as to the health and well being of its populace?
    Can't be that , they have the vaunted european Health care system.

    Just check the number of generics in the pipeline...just waiting

    Europe has hardly any, they process them

    We have thousands

    Only difference...Europe is quite lucky the FDA has no jurisdiction there.

    And another result of the delays in generic processing...Companies holding the patent continue to rake money in hand over fist.

    But perhaps it is as Madame Sec says,
    There may well be smoke...But there is no fire

    I say it is worth an effort to find out

    Parent

    Good for you (none / 0) (#28)
    by Yman on Sun Sep 04, 2016 at 01:15:58 PM EST
    Tell someone who cares - it's not relevant to my point, which was the baseless smears against the Clinton Foundation and your smear against the FDA.  You have no evidence, so you have to resort to "It's not a smear IF it's true".  It IS a smear if there's no evidence to support the accusation.  Accusations in the form of "questions" are not remotely convincing.

    Parent
    Did you vote for Romney? (none / 0) (#29)
    by TrevorBolder on Mon Sep 05, 2016 at 04:10:18 PM EST
    You sure sound like a Romney voter.
    Stating the facts about the FDA does not constitute a smear.
    Europe has far less drugs on its generic "waiting list" than the US, FAR LESS. Because they process them much faster.
    So either Europe is non nonchalant with the health of its citizens, or the FDA is perhaps too cautious by a lot.
    Or, as happens quite a bit with the US government, the lobbyists dollars were successful.
    Whatever the actual reasons are, the ramifications of the FDA actions in processing generic drugs are high cost to people who can ill afford it fro their prescription medicine, and the eeevil corporations continue to rake profit hand over fist with their monopoly on medication.
    So once again, where is the smear? Shouldn't both political parties  be asking the FDA for answers here?
    Why have American citizens be forced to order prescription medication from Canada or overseas?

    All legitimate questions, and yet you sit their and defend the FDA, whose decisions enable the eevil pharmaceutical industry to back the truck up to the vault.
    You really must be a secret Romney voter

    http://tinyurl.com/gvrdxos

    The key to the generic-drug economic model is to keep entry prices low enough to attract multiple competitors. One FDA study estimated that consumers pay 94% of the branded drug's price for a generic if there is only one generic entrant. But the price falls to about 40% if there are four competitors, and 20% when there are eight.

    Yet of the more than 1,300 branded drugs on the market, about 10% have seen patents expire but still face zero generic competition, according to the Department of Health and Human Services. New regulations have, in many cases, made it no longer economically viable for more than one generic firm to enter the market.



    Parent
    "Questions" - heh (none / 0) (#30)
    by Yman on Mon Sep 05, 2016 at 04:37:27 PM EST
    No - you're suggesting actual "answers" with absolutely zero evidence to back them up i.e. smearing the FDA.  Actually, you sound like a Romney voter, since you have trouble remembering what you just wrote, but I'll be happy to help you remember:

    Or is just too difficult to get anything approved by the FDA. I understand Mylan is a major major lobbyist in DC

    Seem to get it done in Europe though.

    Hmmm, FDA has no jurisdiction in Europe...Do they?

    And based on the US system and evidence of successful lobbying in this country, yea, it is a good possibility. Either that or the FDA is just incompetent compared to their European counterparts

    and then even more directly ...

    And the obvious question, why is the FDA preventing the release of generics in the US.
    Lobbying money having its expected results is a obvious answer,

    Sincere questioning of why generic equivalents have not yet been approved is absolutely fine.  Cowardly accusations in the form of "questions" and false dichotomies suggesting the FDA has either been bought by lobbyists or is incompetent - with no evidence to back it up - is not.  But it's pretty typical for the Fox New crowd.

    Parent

    BTW - If you are actually interested (none / 0) (#31)
    by Yman on Mon Sep 05, 2016 at 04:52:14 PM EST
    ... in real answers and comparisons of the FDA versus the EMA (and PDMA) approval times for drugs, rather than false dichotomies and smears, there is research and data out there.  You can start with this report:

    Japan's median approval time in 2013 was 342 days, in Europe it was 478 days, and in the U.S. it was 304 days, making the FDA the fastest of the three.

    The FDA was also faster during the 2004-2013 time period, as approvals averaged 304 days in the U.S., 459 days in Europe, and 487 days in Japan.



    Parent
    Well, those times (none / 0) (#32)
    by TrevorBolder on Mon Sep 05, 2016 at 06:18:47 PM EST
    Are for NEW drugs to enter the market.

    For generics, which would cut a companys profit margin, and drastically help lower the cost of drugs for the average consumer, the dates for approval tell a different story.

    As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.

    By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.

    Parent

    Yep - you said that already (none / 0) (#33)
    by Yman on Mon Sep 05, 2016 at 06:20:48 PM EST
    What you HAVEN'T done is offer any evidence to back up your smears against the FDA ...

    ... because you don't have any.

    Parent

    Once again (none / 0) (#34)
    by TrevorBolder on Tue Sep 06, 2016 at 06:44:53 AM EST
    It is NOT a Smear, if it is true.

    Europe gets it generics to the market place in 1 year,
    The FDA has a lead time of 47 months for generics to hit the marketplace.

    Those are facts, however inconvenient.

    If it isn't crony capitalism, then it is plain incompetence.

    Either one is not a smear, just inconvenient truths.

    Parent

    False dichotomies (none / 0) (#35)
    by Yman on Tue Sep 06, 2016 at 09:37:23 AM EST
    ... and accusations in the form of "questions" are smears.  There are many real reasons the process takes so long,  none of which are crony capitalism or incompetence.  But you have no actual evidence of either,  so all you can offer is a silly,  false dichotomy, with a false choice between them.

    It's sophomoric logic,  but it works with Fox viewers.

    Parent

    And (none / 0) (#36)
    by TrevorBolder on Tue Sep 06, 2016 at 04:21:59 PM EST
    NPR readers

    Parent
    You don't speak for NPR readers (none / 0) (#37)
    by Yman on Tue Sep 06, 2016 at 05:12:13 PM EST
    Just because NPR raises genuine questions about the issue doesn't mean they - or certainly their readers - endorse your Fox News smears in the form of questions.  Not to mention the fact that they're fairly well-educated and anyone with a 6th grade education can spot someone pushing flawed logic and false dichotomies.

    Parent
    Nah (none / 0) (#38)
    by TrevorBolder on Tue Sep 06, 2016 at 07:19:03 PM EST
    Only a ideologue would deny the questions raised by the NPR article.

    But what I can't understand is, aren't liberals against big pharma, and this slow walking of generics benefits the profit margin of big pharma ...immensely. And hurts the American consumer....immensely

    And big pharma lobbies ....immensely

    You really must be a Romney voter, because a concerned liberal would already have known this..

    http://tinyurl.com/hy96jvo

    http://tinyurl.com/z6lwnyg

    http://tinyurl.com/lcz54qu

    Data compiled by the Center for Responsive Politics and commissioned by the Union of Concerned Scientists show that between 2009 and 2011, prescription drug, biotechnology and medical device companies spent more than $700 million lobbying Congress and the Obama administration.
    Over the same period, elected officials on a House subcommittee and a Senate committee with oversight over FDA received nearly $6.3 million in campaign contributions from these industries. Donations went to both Republicans and Democrats.

    I

    n his last months in office, President Obama continues to pursue his policy of appointing industry insiders and lobbyists to important posts within the federal government.

    A glaring example is his recent nomination of Dr. Robert Califf to become the new head of the FDA when current commissioner Margaret Hamburg steps down in March.
    Califf's appointment is hardly surprising'

    In other words, let the fox guard the hen house - which seems to have been the guiding philosophy behind many of President Obama's appointments.

    As Jeffrey Phillips of WeAreChange.org noted:

    "Califf's appointment is hardly surprising. Michael Taylor, the current Deputy Commissioner for Foods at the FDA -- also appointed by Barack Obama -- used to be Monsanto's vice president for public policy.

    "Collusion between corporations and the FDA is widely documented. This influence has presumably contributed to many questionable decisions, such as the FDA's approval of oxycontin for children or the ongoing approval of countless dangerous drugs that are later recalled."

    Democrats such as Bernie Sanders and Elizabeth Warren have been outspoken in opposition of the Califf nomination, but there is at least one Republican member of Congress who also believes he is unfit for the role of FDA chief.



    Parent
    You should buy a horse ... (none / 0) (#40)
    by Yman on Tue Sep 06, 2016 at 08:10:21 PM EST
    ... for all that straw you use in your arguments.  Of course, then you'd only have even more of the byproduct to deal with.

    1.  No one is denying NPR's legitimate questions.  What I'm saying is your "questions" aren't questions at all - they're just bull#$hit smears phrased as "questions" because you have no actual evidence.

    2.  Your "Natural News" links were funny.

    3.  Your "report" (as opposed to an actual study) by some sociologist was even funnier.

    4.  You still have no evidence to back up your smears.

    Oops.

    Guess you're a Romney voter.

    Parent

    Actually (none / 0) (#41)
    by TrevorBolder on Tue Sep 06, 2016 at 08:20:49 PM EST
    I was.

    And once , the liberal with no argument falls back upon the last bastion of losers...The Source..The Source

    What, a Harvard study is not good enough for you? The dollars spent on lobbying far surpassed the insurance industry, the facts linking Obama's new FDA head with Big Pharma, you didn't like those either. I know, facts are just so inconvenient some times.

    All the facts in the articles were accurate and irrefutable, as you didn't even try.

    And so now you oppose the great liberal lions Warren & Sanders??

    Hah!!  The only reason I can gather you post your juvenile Pee Wee Herman retorts is that this is another episode of Big Government gone wrong, and that bothers you. Or just the fact that I pointed it out, very childish of you, but I do notice you revel in these with other non liberals, I found my facts , proved my point, you can go back and argue with your other "friend" now

    For every liberal I know detests Big Pharma, and bemoans the ineffective FDA.

    Parent

    You were? (none / 0) (#42)
    by Yman on Tue Sep 06, 2016 at 09:05:44 PM EST
    That's not a surprise in the least.

    The credibility of a source offering an opinion is always an issue when those opinions are offered as evidence.  The fact that you're reduced to citing some sociologist in a "Natural News" blog is funny - but not convincing.

    BTW - A Harvard study would be persuasive, if it said what you are saying - but it doesn't.

    Oops.

    The rest of your response if just more silly, straw arguments.  You really should get a horse ...

    ... and a shovel.

    Parent

    Ok Pee Wee (none / 0) (#43)
    by TrevorBolder on Tue Sep 06, 2016 at 09:09:50 PM EST
    That's all you can come up with? (none / 0) (#44)
    by Yman on Tue Sep 06, 2016 at 09:12:58 PM EST
    pffffttttt ...

    (snicker)

    Parent

    FDA Big Pharma Lovefest (none / 0) (#39)
    by TrevorBolder on Tue Sep 06, 2016 at 07:41:44 PM EST
    http://tinyurl.com/janzfz4

    Freedom from prosecution?

    Federal law makes it illegal for Medicare and Medicaid to do business with "an excluded or debarred entity resulting from serious criminal charges." Accordingly, the FDA consistently refuses to prosecute major drug companies for wrongdoing so they can keep doing business with one another. For example, when Merck's Vioxx drug was pulled from the market because evidence showed it greatly increased the risk of heart attack, the company was able to get away with paying a criminal fine and pleading guilty to one misdemeanor--no serious criminal charges were ever filed by the government, despite the fact that Vioxx killed about 60,000 people.


    There are many, many examples of revolving door officials:  Let's list the big ones in our article.

    Claude Burcky, who took a job at Abbott Laboratories after negotiating a US/Australia trade deal that "undercut access to affordable medicines for Americans and Australians."
    Peter Pitts who, after serving as the FDA's associate commissioner for external affairs, joined a major lobbying firm to "counsel pharmaceutical, biotech, and food companies...on driving thought leadership on food and health issues facing the industry."
    Michael Taylor, the perfect example of a revolving door "sandwich." He started as an attorney for Monsanto, then "stopped by" the FDA long enough to draft FDA's policies decreeing that GMOs are "generally recognized as safe" and are exempt from labeling, and then went back to Monsanto, before returning to a key FDA job in the Obama administration.
    Elizabeth Fowler, who wins the dubious recognition of being the "embodiment of corporatist revolving-door greasing." She started as a top aide for Sen. Max Baucus, then left to become a lobbyist for WellPoint, the nation's largest health insurance provider. She then went back to Sen. Baucus's office, where she became the acknowledged architect of the Obamacare legislation (which, of course, was a huge gift to the private insurance industry). Ms. Fowler then joined the White House in order to oversee the implementation of Obamacare, only to leave for a senior-level lobbying position at Johnson and Johnson.
    The latest winner of the FDA-Big Pharma revolving door lottery is Dr. Robert Califf, the new FDA commissioner. Dr. Califf's lucrative dealings with the drug industry are well known. He ran a clinical research center at Duke University that received the majority of its multi-million-dollar budget from Big Pharma. According to financial disclosures from last year, Dr. Califf received money for consulting with at least seven drug and medical device companies, and, according to the New York Times, six other companies at least partially underwrote his university salary, including Merck, Novartis, and Eli Lilly. The conflict-of-interest section of a paper he wrote for the European Heart Journal last year lists financial support from more than twenty companies.




    Parent
    The "Alliance for Natural Health"??? (none / 0) (#45)
    by Yman on Tue Sep 06, 2016 at 09:16:52 PM EST
    Hahahahahahahahahahahahahaha ....

    Parent
    Trevor, it's been my experience (none / 0) (#12)
    by fishcamp on Fri Sep 02, 2016 at 08:04:13 AM EST
    if there is a generic version of a medication available the pharmacist will not fill the prescription with the original version, since many insurance companies, including Medicare, will only pay for the generic drug.  They usually call the doctor, who may not know a generic version just came out.  

    Parent
    Epipen is different in that regard (none / 0) (#15)
    by Abdul Abulbul Amir on Fri Sep 02, 2016 at 03:36:34 PM EST
    It helps that Mylan's CEO is the daughter of a US Senator.

    Parent
    Does it? (none / 0) (#18)
    by Yman on Fri Sep 02, 2016 at 07:35:17 PM EST
    How does it "help".  Be specific here, because it's fun pointing out how fact/evidence-free your silly CTs are.

    Parent
    Yes (none / 0) (#16)
    by TrevorBolder on Fri Sep 02, 2016 at 04:35:32 PM EST
    In most cases.
    EpiPen (Mylan) had specific legislation passed preventing generics from being substituted without a new prescription being written for the 1 generic version currently available in the US.

    But again, I feel the bigger issue is the fact that there is vast differences between Europe approving generic versions of drugs, and the US.
    And that difference is the FDA

    NPr link below discusses it

    http://tinyurl.com/hndsyqv

    Parent

    Ther check was from Mylan (none / 0) (#14)
    by Abdul Abulbul Amir on Fri Sep 02, 2016 at 03:34:28 PM EST
    She is/was the CEO.  

    Are you also saying that the Koch brothers have no responsibility for the donations of Koch Industries.  You are a hoot.

    Parent

    What I'm saying ... (none / 0) (#17)
    by Yman on Fri Sep 02, 2016 at 07:34:01 PM EST
    ... is that she made no donation.  The company made a donation.  See if you can tell the difference between the two ... it's not hard.

    I'm also saying your silly smear about the Clinton Foundation is complete bull$hit which you offer, as always, with no evidence.  Let me know if you need any help interpreting that.

    Parent

    The generic version of Prilosec (none / 0) (#21)
    by fishcamp on Fri Sep 02, 2016 at 10:15:57 PM EST
    the popular and relatively expensive, over the counter, acid reflux drug is Omeprazole.  My pharmacist said it costs exactly the same as Prilosec because they are the only people manufacturing it.  Medicare will only pay for the generic version, even though it's the same price as the original drug.  Strange but true.