Pharma Deal With White House Delays Health Reform
50 CommentsBy Ed Silverman // December 11th, 2009 // 9:48 am
A deal between the White House and the pharmaceutical industry is holding up a bipartisan amendment to allow the importation of cheaper meds from abroad, according to reports. The Senate has been debating the amendment, sponsored by North Dakota’s Byron Dorgan this week, but has not voted, which is causing a delay in floor action on healthcare reform.
His amendment, which would permit bulk exports of meds from countries such as Canada, enjoys broad and bipartisan support and likely has the backing of more than 60 senators, which would guarantee its adoption on the healthcare reform bill, The Hill writes.
“People are walking on eggshells,” Dorgan, a Democrat, tells The New York Times. “If we pass legislation allowing people freedom to import drugs, the pharmaceutical industry might not support the health care bill.”
Drugmakers oppose legalizing additional imports and say the government can’t guarantee the safety of imported meds. You may recall that the White House and PhRMA, the industry trade group, struck a deal this summer to limit industry exposure under health care reform to $80 billion over 10 years, although terms were never fully disclosed.
And The Hill reminds us that President Barack Obama was one of the 35 co-sponsors of Dorgan’s drug reimportation legislation when Obama served in the Senate. In addition, White House Chief of Staff Rahm Emanuel was a leading supporter of the House version of the bill when he served in the lower chamber
The Dorgan amendment is co-sponsored by 19 senators, including Maine’s Olympia Snowe and Arizona’s John McCain, both Republicans, who have been leading the floor debate. Democratic senators from states home to drugmakers, including Tom Carper of Delaware, and New Jersey’s Frank Lautenberg and Robert Menendez, object to the amendment.
In a letter to the Senate, FDA commish Margaret Hamburg, wrote that imported drugs may be contaminated or counterfeit because the agency “does not have clear authority over foreign supply chains.”
However, the Congressional Budget Office estimates Dorgan’s amendment would save the federal government $19.4 billion over the next decade, because federal programs would spend less on drugs, and Dorgan aruges consumers will save about $100 billion over the next decade due to the lower prescription drug prices that will result from the legislation, the Pink Sheet notes.
Hamburg added that $5 million is included in FDA’s budget to begin working with various stakeholders to develop policy options related to drug importation.
PhRMA sent us this statement: “It would be a huge mistake for Congress to pursue policies that could expose Americans to counterfeit and substandard drug products and potentially weaken the Food and Drug Administration and the Department of Homeland Security by crippling their ability to protect public health and safety. The recent announcement by FDA about counterfeit H1N1 influenza products entering the US from foreign countries is just one example of how importation proposals could put patients’ health and safety at risk. Simply put, Congress should not be playing Russian roulette with the safety of patients.”
Justice in MI
In this case, I think I would go with Margaret Hamburg if she has the data to support the claim based on drugs from licensed, Canadian pharmacies (and assuming that can be known).
harry
great move Mr Dorgan. a democrat who takes a stand. payback time for the spineless politcians who got rid of the public option.
Fred Nelson
I doubt drug reimportation will move forward due to FDA opposition on the account of safety. I do expect additional provisions eventually in the legislation as the Hill looks to come after Pharma based upon the recent reports and House hearing on price hikes in the face of the pending reform legislation.
Lisa Van Syckel
FDA has lost their credibility over the years. The Vioxx and Paxil scanda come to mind, and lets not forget the bullying and the muzzeling of their own medical reviewers.
harry
fda and drug safety, how ironic.
reg agencies and pharma use the contaminated, counterfeit meds as a smoke screen to try and make it seem as though they are working to-gether, as a team, to prevent patients from taking contaminated, counterfeit drugs, how warm and fuzzy.
I am sure more patients are killed from the side-effects of FDA approved drugs than contaminated, counterfeit drugs. why don’t the FDA work to-gether with pharma to prevent patients from taking pharma/FDA drugs, with lethal side-effects.
Dr. Dave
Does anyone really think companies will allow their own drugs to be re-imported? When Canadian pharmacies were going full steam a few years ago, the big companies quickly limited sales to those companies to levels “that were appropriate to the market they served”.
If the pharma companies start to limit sales to Canada, do you really think the Canadian gov’t will allow drug shortages to happen?
This will not work and it’s just another example of how politicians have NO idea how the economy works.
DD
patrons99
Well stated, harry. FDA, pharma, and drug safety. How totally ironic! “Drugmakers oppose legalizing additional imports and say the government can’t guarantee the safety of imported meds.” The reality is the government (FDA) can’t even guarantee the safety of domestic marketed meds. The opposition from PhRMA and pharma to imports has nothing to do with safety. Their real concern is controlling prices and protecting their profit.
Hap
It’s pretty spineless to expect other countries to do our work for us - reimportation is effectively making our prices subject to the limitations that Canada puts on their drug prices. If Congress wants to limit drug prices, they ought to either limit them themselves (and accept the consequences, either by accepting a lower supply of drugs or by funding its own drug research) or find another way to get drugs to people who need them.
The safety issue is a red herring - if it isn’t, I’m sure other countries might be willing to exert pressure on pharmaceutical companies to render their drugs safe for their markets. Telling Canada that its drugs aren’t safe ought to go over well with them, after all.
pharmavet
The Canadian market is pocket change for Big Pharma due to small population and price controls. I worked for a company that sold the same drug in US for 10X the price in Canada. The last time this issue came up, we decided that if reimportation became law we would simply stop selling this product in Canada. The small hit to the bottom line would be the price of doing business. If this approach holds form in the rest of Pharma, the ones to suffer will be the Canadians.
Anonymous
Pharma manufactures meds in China (which can’t even produce safe milk) them brings them into the US….and they’re afraid of meds from Canada?
Compliance Analyst
A lot of APIs are produced in China/India, but not as much in terms of finished product (~20% from last I heard estimated).
Anonymous_
The meds in Canada that are (by the way not manufactured there either) from those registered in the US such as Glaxosmithkline (actually a UK headquartered company), Novartis (actually a Swiss company), Sanofi-Aventis (Actually a French company) and Pfizer/BMS/Merck/Eli Lilly (manufacturer anywhere but here companies) are the same as the the ones that are here in the US as well as in the UK.
The issue is whether the FDA can still control the supply chain with a pharmacy, not a pharma being the middle man… considering that the bulk of drugs available in the US are not manufactured here anyway- exactly how much safety is the FDA guaranteeing now as they don’t do many foreign inspections…
The precise point of the bill is that the drugs aren’t being made here, we pay more for them than anyone else in the world and they are the same drug, here is something that Congress can maybe do on a small scale– because they are afraid of the drug lobby. As we can all tell.
Fred Nelson
Hap you’re right. Much easy and less of a dog fight for the Hill to take care of biz themselves if they really want to. Both the House and Senate bills require Medicare to negotiate drug prices… however there’s no stick, e.g. no formulary, so appropriately the CBO has assigned $0 savings on that piece of the legislation. If the Hill wanted to take care of business and they might… they simply could institute some sort of formulary in Medicare. A bit dicey on implementation but it is still a looming possibility.
Evelyn Pringle
I think it’s ironic that when the Medicare Prescription drug bill was passed, all the Democrats were saying the Republican were in Pharma’s pocket because they ruled out importation.
Funny now that drug company money has poured into Democratic coffers, many seem to have changed their tune.
As for the secret deal Obmama and Baucus made with the industry, what is $8 billion a year divided amongst the whole drug industry.
Nothing.
Besides, I thought Obama said during the campaign that there would be no secret deals, that negotiations would be broadcast on C-Span.
As I recall, he said something to the effect that if politicians wanted to carry the water for the drug companies let them do it on national TV.
I guess the luxury of living in the White House can change a guy’s mind on all kinds of issues.
Atlex
It is funny and worth noting that Dorgan, while heavily in favor of importing drugs from Canada, is also a leader in the effort to bar or limit importation of beef from Canada, citing among other things–safety. I guess that if Merck, Pfizer and Lilly (et al) were in North Dakota, he’d be against drug importation as well.
anonymous
Atlex– any idea who in Congress might have a long view of sustainability beyond their reelection chances? It does seem like self-interest versus public interest drives many decisions lately.
Jack Friday
I agree with Evelyn. I had such high hopes for Mr Obama.
http://www.rollingstone.com/politics/story/31234647/obamas_big_sellout
Jaynesday
Evelyn and Jack, pursuant to your concerns about politicians flipping when confronted with pharma deals, I have the same concern for the medical device bill resting now in Congress. Gov track - H.R. 1346: Medical Device Safety Act of 2009
This Spring it was continuously in the news as the Democrats talked of the need to impose product liability. But for months now it seems to be forgotten.
I would think the Pharma would have used the health care reform bill as leverage to eliminate support. Is this devices bill also a chip on the health care reform table?
Atlex
anonymous, I would be hard pressed to find anyone in the Senate or House who looks beyond their own electability. I’m sure there are a few, but not many.
Justice in MI
Yes, we all know where drugs are manufactured, yadayadayada.
The question is this. Margaret Hamburg is quoted:
“In a letter to the Senate, FDA commish Margaret Hamburg, wrote that imported drugs may be contaminated or counterfeit because the agency “does not have clear authority over foreign supply chains.”
Does anyone here sincerely believe Margaret Hamburg is “on the take” and does not believe what she wrote?
The supply chain issue is _not_ the same as the site of manufacture issue, and a number of “Canadian pharmacies” are, indeed, U.S. operations with Canadian subsidiaries who care even less about patient welfare than folks worst nightmares (often expressed on this blog).
Anonymous_
If Margaret Hamburg actually had clear control over the supply chain as is– then would it really have taken all those months to trace the contamination for Heparin? They are not testing the drugs individually by batch as they come into this country nor are they often inspecting foreign manufacturing sites, nor are they often auditing GMP outside the US. Let’s get real here. Dorgan was right when he said Lipitor is made in Ireland and Pfizer is guaranteeing the same product in the US and Canada.
The amendment is that “US FDA approved drugs” would be allowed to be purchased from the very same “US FDA approved manufacturing sites as those that are coming in currently with a verifiable chain and registry. The only difference is that the pharmacies and wholesalers in this country would be contracting with Canadian/UK etc. wholesalers.
And the pharma could not limit the supply as a means to keep the parallel imports from happening but would have to completely leave that country.
Dorgan has taken the arguments he has gotten for the last five years over this amendment- and actually come up with a system that is more accountable than how the FDA currently deals with imports..
It is not that believe that Margaret Hamburg is on the take but she is naive at best if she doesn’t realize that the FDA has no foreign supply chain control prior to or after manufacturing to speak of… if heparin didn’t teach you that then the exodus to Asia will in the future.
Evelyn Pringle
I will address a couple of replies.
First of all, Hamburg’s statement is almost the exact same statement made by the Bush team and Republican in 2003 when passing the Medicare Prescription Drug bill, which Democrats ridiculed mercilessly at the time.
To Jack Friday, I did not have high hopes for Obama. I took the time to investigate him in the spring and summer of 2008 because I thought I would be writing articles in support of his candidacy and realized that I knew nothing about the guy.
As a result of a 2 and half month investigation, done on my own time, instead of supporting Obama, this previously die-hard Democrat, ended up writing I think 12 articles exposing him for the corrupt fraud that he was and basically warned the American public about what would happen if he ended up in the White House.
I received quite a hammering for doing so at the time, from fellow Democrats who presumably went on to vote for Obama, but are now singing a different tune a mere 11 months into his Presidency.
The articles can be found by googling my name and Obama.
To Jaynesday, I too have been wondering what will become of the device maker bill and have noticed how everything has died down since Spring.
However, people may want to consider that the White House Office of Health Reform Czar, Nancy-Ann DeParle, earned more than $6.6 million as a paid director for U.S. healthcare firms, records indicate, as UPI reported on December 8, 2009.
UPI says the Washington Times reports that most of the companies, such as DaVita Inc, Boston Scientific Corp, Guidant Corp, and Specialty Laboratories Inc, have a vested interest in outcome of the healthcare industry reform measures now being considered by the Congress.
There was another story about her appointment on June 12, 2009, by Politico.
“In the days after her appointment, she stepped down from the corporate boards of Cerner, Medco Health Solutions, Boston Scientific, CareMore Health Plan and Legacy Hospital Partners, as well as from her post as managing director of a private equity firm that controlled some of those companies and a variety of other health care firms,” Politico wrote.
Obviously, the Obama administration is following the template set by the Bush administration, where industry insiders step in for a year or two of “public service,” and then will go right back to their top money making jobs in the health care industry.
harry
There is a difference between counterfeit and contaminated. I am thinking, counterfeit drugs, pharma are most afraid of because they threaten their own supplies and are manufactured outside of the FDA regulation. viagra? contamination may happen in FDA regulated products and seem to cause more problems for patients but pharma and the FDA don’t bother about this too much, ie heparin. inspectors in china.
Justice in MI
Anon,
You write in one par.:
The amendment is that “US FDA approved drugs” would be allowed to be purchased from the very same “US FDA approved manufacturing sites as those that are coming in currently with a verifiable chain and registry. The only difference is that the pharmacies and wholesalers in this country would be contracting with Canadian/UK etc. wholesalers.
There appears to be a closed quote missing. Is it after “registry”?
Justice in MI
Here is Dorgan’s quote as cited in Ed’s lead-in:
“My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk. It applies only to F.D.A.-approved prescription drugs produced in F.D.A.-approved plants from countries with comparable safety standards.”
I am hearing essentially two responses.
1. FDA essentially has no control now over contaminated or bogus products (e.g., Heparin)manufactured overseas (e.g., . China).
2. Thus, it will make no difference–they will have equally no control–to allow reimportation as proposed by Dorgan. Language like “countries with comparable safety standards” is either a cause for contentment or cynicism, but it should provide no basis for increased concern.
Do I have read you right?
BP Watch
This is a deal with the DEVIL!! Big pharma has made it’s bed by their actions over the past 8-10 years and should be made to lie in it. No more breaks for these guys. The top executives have been using the health care system for their own benefit. make them suffer!
Former SP
Oh Pharma, how I hate thee,
let me count the ways!
Wait, too numerous to count,
you greedy bastards!
Hope you all go to hell,
and burn til it hurts!
Justice in MI
I find it “ironic” that people who demonize pharma as a matter of faith miss the fact that reimportaion potentially opens the door even more widely to the same devil.
The international market in bad product is about as ruthless as anything anywhere–it’s not about fuzzy little Canadians in red suits and Smoky the Bear hats.
In the meanwhile, the amount of international bribery/graft that goes on–including much participated in by the big pharma cos. in order to bypass the usual inspection and clinical trial requirements–is boggling.
The knee-jerk respose that this is some sort of bogus problem–while psychologically understandable–requires putting away precisely the distrust in industry that so often characterizes commentary here.
Wake-up time.
Former Pharma Marketing Director
Folks,
You are forgetting one very important fact, and I have to admit it has me laughing - not at you but at our senate!
The reason the drugs are less expensive in Canada is because Canadians have UNIVERSAL HEALTH CARE!!!! This means the government negotiates prices with Pharma since the government picks up the tab on some of the drugs, not all of them mind you. This was as per a deal cut a few years ago, which I note Pharma is not really keeping their end up, the last I checked anyway.
So, solve our problems by allowing us to reimportant drugs from Canada that are cheaper? If we can do this then we will stop stonewalling the Health Care reform bill - um the drugs are cheaper in Canada, because of Canadian Health Care Reform….
By, the way, last I checked the drugs were not really always that much cheaper. Nice of the senate to bring this up though, I bet by the time they get there act together, Pharma will have taken another price increase…..
A country is judged by how they handle their most vulnerable population. Why do we do things that continually tightens the noose around the neck of our ill patients?
OK, I stopped laughing now….
Justice in MI
Hey, good points, Former. My “sense” is that brand names are often considerably cheaper in Land o’ Maple Leaf, while generics are often more expensive. Eh?
You ask: “A country is judged by how they handle their most vulnerable population. Why do we do things that continually tightens the noose around the neck of our ill patients?”
Yeah, that’s a laugh-stopper.
Anonymous_
Justice- Maybe it would be easier to provide you the text and the link to see how it changes the FDCA: As you can see - it merely substitutes the wholesaler for a manufacturer in a closed system. It does not allow the importation of every drug. Your most expensive drugs, often given by infusion, would not be covered. It does have a track and trace system that the secretary must provide and those who register. And gives the secretary right of first refusal for exporters — these are your small molecule drugs were there is still significant price differences, especially near patent expiry.
And as for the international market, that is where all our drugs are coming from now. If you are currently taking Lipitor, you’d better hope the gentleman who works for the Swiss government is not on the graft because the only way it is getting tested once it gets here is after a problem pops up.
full text:
http://www.govtrack.us/congress/billtext.xpd?bill=s111-525
Summary:
http://www.govtrack.us/congress/bill.xpd?bill=s111-525&tab=summary
SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.
‘(a) Importation of Prescription Drugs-
‘(1) IN GENERAL- In the case of qualifying drugs imported or offered for import into the United States from registered exporters or by registered importers–
‘(A) the limitation on importation that is established in section 801(d)(1) is waived; and
‘(B) the standards referred to in section 801(a) regarding admission of the drugs are subject to subsection (g) of this section (including with respect to qualifying drugs to which section 801(d)(1) does not apply).
‘(2) IMPORTERS- A qualifying drug may not be imported under paragraph (1) unless–
‘(A) the drug is imported by a pharmacy, group of pharmacies, or a wholesaler that is a registered importer; or
‘(B) the drug is imported by an individual for personal use or for the use of a family member of the individual (not for resale) from a registered exporter.
‘(3) RULE OF CONSTRUCTION- This section shall apply only with respect to a drug that is imported or offered for import into the United States–
‘(A) by a registered importer; or
‘(B) from a registered exporter to an individual.
‘(4) DEFINITIONS-
‘(A) REGISTERED EXPORTER; REGISTERED IMPORTER- For purposes of this section:
‘(i) The term ‘registered exporter’ means an exporter for which a registration under subsection (b) has been approved and is in effect.
‘(ii) The term ‘registered importer’ means a pharmacy, group of pharmacies, or a wholesaler for which a registration under subsection (b) has been approved and is in effect.
‘(iii) The term ‘registration condition’ means a condition that must exist for a registration under subsection (b) to be approved.
‘(B) QUALIFYING DRUG- For purposes of this section, the term ‘qualifying drug’ means a drug for which there is a corresponding U.S. label drug.
‘(C) U.S. LABEL DRUG- For purposes of this section, the term ‘U.S. label drug’ means a prescription drug that–
‘(i) with respect to a qualifying drug, has the same active ingredient or ingredients, route of administration, dosage form, and strength as the qualifying drug;
‘(ii) with respect to the qualifying drug, is manufactured by or for the person that manufactures the qualifying drug;
‘(iii) is approved under section 505(c); and
‘(iv) is not–
‘(I) a controlled substance, as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802);
‘(II) a biological product, as defined in section 351 of the Public Health Service Act (42 U.S.C. 262), including–
‘(aa) a therapeutic DNA plasmid product;
‘(bb) a therapeutic synthetic peptide product;
‘(cc) a monoclonal antibody product for in vivo use; and
‘(dd) a therapeutic recombinant DNA-derived product;
‘(III) an infused drug, including a peritoneal dialysis solution;
‘(IV) an injected drug;
‘(V) a drug that is inhaled during surgery;
‘(VI) a drug that is the listed drug referred to in 2 or more abbreviated new drug applications under which the drug is commercially marketed; or
‘(VII) a sterile opthlamic drug intended for topical use on or in the eye.
‘(D) OTHER DEFINITIONS- For purposes of this section:
‘(i)(I) The term ‘exporter’ means a person that is in the business of exporting a drug to individuals in the United States from Canada or from a permitted country designated by the Secretary under subclause (II), or that, pursuant to submitting a registration under subsection (b), seeks to be in such business.
‘(II) The Secretary shall designate a permitted country under subparagraph (E) (other than Canada) as a country from which an exporter may export a drug to individuals in the United States if the Secretary determines that–
‘(aa) the country has statutory or regulatory standards that are equivalent to the standards in the United States and Canada with respect to–
JaT
I watched this debate in the Senate and what killed me the most (literally yelling at my TV) were the comments by the NJ Senator.
He was going on about counterfeit drugs and how FDA approved drugs by domestic providers do not leave consumers wondering what is in their medication. He also spoke to our FDAs safe practices.
What?!?!?
Pardon me, Sir,
The Dilantin ANDA was apparently approved by the office of generic drugs, without review. Has anyone even confirmed the AUC that is claimed? Bet not.
Please don’t imply that the dangers of counterfeiting only comes from abroad.
Me: Do you have any of the old Dilantin Kapseals?
Pharmacist: You mean the name brand product?
Me: Well, yes, but they changed it and I cannot take the new one. They are both name brand Pfizer/PD products.
Pharmacist: Let me look.
~walks to the shelf, opens the bottle, :~O (surprise), calls the manufacturer… etc. etc.~
Pharmacist: We will not be getting the other formula anymore.
This happened over and over as I searched for Kapseals. Does it mean that counterfeiting is not counterfeiting if an American company does it?
Because our doctors and pharmacists no longer knew what they were dispensing.
______________________________
Olympia Snowe laid out the plan for confirming where drug ingredients come from (for both foreign and domestic drugs), with a tracking system, and those products having a pedigree for safety. Of course pharma doesn’t like it.
One of the Senators spoke to the fact that many of our products are not domestically made as it is.
My neuro actually disclaimered himself by saying he does not own Glaxo stock when he wrote one prescription. I was puzzled until I had it filled. I have a fortune in drugs I cannot take. What I don’t have anymore is my house and the reasonable well-being I once enjoyed.
If HCR is partly about cost then pharma has cost my insurer a small fortune in MD & Neuro visits, prescription fills, MRIs, EEGs, ER visits leading to more prescription fills, and on and on.
My average treatment schedule (pre-reformulation) was twice a year. Two sets of labs a year. And my med refills. That WAS the extent of my cost to myself and our insurer for controlling epilepsy. That is how well I once was. That is why I cannot just sit here and take it.
I couldn’t find the whole debate but this is Dorgan speaking on his amendment.
http://www.youtube.com/watch?v=IJxBlrPgH7A&feature=related
http://www.youtube.com/watch?v=m5JysSwRzm8&feature=related
JaT
What this should say is not…
My average treatment schedule (pre-reformulation) was twice a year
but rather…
My average treatment schedule (pre-reformulation) was 2 MD visits a year.
harry
I think I understand finally from reading the above posts! reimportation means that the US government will negotiate with canadian wholesalers rather than US drug companies directly. cuts out, not the middle man but the drug companies in the US who have the legal authority to charge high drug prices because of medicare, which the gov pays for. I don’t see where the safety issue comes to play? Why does the government not just negotiate directly with the drug companies? wouldn’t that be easier. apologies if there is a previous post that explains the reason.
harry
I think I understand finally, I hope, from reading the above posts! reimportation means that the US government will negotiate with canadian wholesalers rather than US drug companies directly. cuts out, not the middle man but the drug companies, who have the legal authority to charge high drug prices in the US because of medicare, and insurance plans. I don’t see where the safety issue comes to play? Why does the government not just negotiate directly with the drug companies? wouldn’t that be easier. apologies if there is a previous post that explains the reason.
Justice in MI
Great stuff, anonymous, thank you.
But my question remains. If, as we all know, we are already dealing with an international manufacturing system which is not “under control,” would it not make sense that reimportation would add to the problem?
Real question. I’d be more than happy if the answer was No.
Justice in MI
A personal aside–I was interested to see that
“sterile opthalmic solutions” were to be excluded by this reimportation bill.
It happens, that my own experience with the issue concerned an eye drop I was using that went off patent. At that point, the manufacturer tweaked its formulation, and discontinued sales of the original drop in the U.S. (but not in some 30 other countries).
The original drug continued to be made in California, and was exported to those thirty other countries. But it was not available to anyone here. As it turns out, the tweaked version didn’t work for me (and, as FDA documents show, for many others). But I was up the creek until a generic came out–an event that the brand company was able to delay for about two years post patent expiration.
Anonymous_
Justice– the finished product is the same–it is truly switching the middleman. I am not certain that I find a reputable exporter under the guidelines Dorgan has set out any different than the current system- just lower markup.
The safety issue is the supply chain before the finished product that is the issue.. that was the case with heparin and will be in the years to come.. where drugs are manufactured, suppliers used and subcontractors along the way that is where the danger to cut corners, not to abide by GMP, no one looking at manufacturing facilities in countries like Singapore, Thailand, etc. and manufacturers who fall victim to suppliers who “change” ingredients without their knowledge to make a larger profit margin.
Justice in MI
Thanks for all the clarifications, Anon.
Change of topic, but today’s long NYT piece on Wyeth/Premarin–combined with a bushel of court documents–pretty chilling, even relative to the stories we have become used to hearing.
JaT
Anon?
“Justice– the finished product is the same–it is truly switching the middleman.”
“manufacturers who fall victim to suppliers who “change” ingredients without their knowledge to make a larger profit margin.”
“the finished product is the same”
““change” ingredients”
Maybe this can be resolved with the pedigree system that Dorgan/Snowe includes. Why doesn’t pharma like it if they fall victim to their suppliers? Maybe it lies with purchasing and the purveyor that offers the best deal?
cliffintokyo
What is missing from the above discussion are the financial numbers.
If, as people say here, the gov only intends to allow in some generic products from Canada, this will not hurt US pharma industry.
If this is correct, the objections by big pharma are purely political blustering and should be treated as such and ignored.
If there is a quality problem (unlikely in my view), FDA can say ‘we told you so’.
Former Pharma Marketing Director
Cliffintokyo,
You are probably right, it is “political blustering”.
Pharma doe snot want to have to negotiate with governments about the price of their drugs.
Lowering drug prices in the US will significantly help other Countries to lower their prices.
We really need to start educating people to stop taking drugs that are not absolutely necessary and those who are on drugs, must find a way off - it is completely ravishing our health and health care plans…
JUST SAY NO TO DRUGS!!!!!
patrons99
OMG! I never thought I’d hear a former pharma say “Just say no to drugs!” When did you find religion? You are starting to sound a bit like a naturopath. In all seriousness, I’d love to see a health care system that promoted wellness, probably through some combination of allopathy and homeopathy. Some drugs are life-saving. Many others, however, are a complete waste of health care resources, e.g., uppers, downers, sleep-aids, sex-toys, me-too drugs. Quite a few marketed drugs are of very dubious safety. Some marketed drugs are actually dangerous, and should never have been approved in the first place.
Pharma Clarifier
As a pharmaceutical executive I was involved in the investigation of counterfeit Lipitor that was imported through a very elaborate supply chain set-up several years ago. It took the intensive cooperation of industry, FDA and customs, and countless man-hours of time to solve the mystery. This is a legitimate reason for FDA being fearful of reimportation, not the hogwash on this board about FDA “protecting” Pharma. I firmly believe that if we legalize reimportation we will be inviting similar problems on a massive scale.
cliffintokyo
PC: Thanks for the inside story
“Similar problems on a massive scale” is really
rather *hyperbolic* though.
So what FDA is really worried about is the disproportionate amount of resources needed to unravel the few cases of counterfeits that might emerge (despite the tough new labeling recommendations that will make fakes easy to spot).
We are really most interested in seeing the copy products quickly off the market; we don’t actually care about all the follow-up work that FDA has to do up to the successful prosecution of the trangressors.
So let’s accelerate the introduction of the new labeling and make sure FDA has enough resources and muscle; happy?
It is not really helping FDA to pretend that pharma is working hand-in-hand with them; that is just what the public is afraid of.
Anonymous_
Pharmaclarifier.. the example you cite is an example that could happen with reimportation… but it did happen without it..Why? BECAUSE LIPITOR ISN’T MADE IN THE US SO IT IS IMPORTED IN ANYWAY….
Heparin was adulterated and killed individuals and not because it was reimportated but because it had a global supply chain just the same as Lipitor…it probably happens now and you know it still cost more than in Canada. So we pay more for what?
If Pharma wants to stand up and say it isn’t safe and the US pays a premium for safety, then make that be the case. Go back to buying API in the US and manufacturing for the US only in the US. Unless you are willing as an industry to do that then it is pure hyperbole to pretend that the higher prices support safety for the US or to save R&D that is moving to Asia at amazing speed.
If you want to charge the US a premium, advertise unchecked and market with regulations more lax than any other country under the name of “free speech” then maybe in return the US consumer could get a little more for their money than the one in Canada and that would be a closed manufacturing and supply chain.
pharmavet
Cliff, it is so thoughtful of you not to care about counterfeit imports. Tell that to the patients who may have suffered a serious adverse event from not receiving their genuine Lipitor. Maybe they don’t take such things as seiously in Tokyo, but they darn sure as well do in the United States. The reality is that the FDA customs division is a weak link in the supply chain. Why should they have to devote scarce resources to “muscle up” when banning reimportation will allow them to devote those resources elsewhere, like approving critical new important medicines more rapidly.
Anonymous_
Pharmavet you act like the FDA is the issue here??.. It is pharma that created this condition between outsourcing and offshoring … giving countries with loose regulatory and even sketchier skills a role in the supply chain- teaching them what is it in it and what it looks like.. How long did you think that it would be before they learned to do it without you and pocket the money? Places where toothpaste and dog food are routinely adulterated?? .. Not to mention creating such insane margins between pricing in the US and Canada that it is incentive for counterfeiters.
There would be no imported Lipitor if Pfizer was just manufacturing in Groton.. Oh wait, Lipitor is in Ireland.. and they closed that down to move to Asia anyway.
Approving critical new important medicines should take longer considering the changes that pharma has made in R&D and manufacturing. The FDA is all the American public has and that is not saying much.
The current state of affairs has little to do with the truly dedicated employees and amazing scientists at pharmaceutical companies who have truly been shafted these last few years, especially in the U.S.
It has everything to do with the C-suite and above that has put their own salary/bonus interests, Wall Street expectations and short term profitability ahead of safety of the consumers of their products, job security for their employees and longterm profitability and viability of their industry. They did us all a disservice.
cliffintokyo
PV
I did not write that I do not care about patients; and the problem is counterfeits not reimports.
It is really up to pharma, not FDA, to quickly introduce labeling that allows us to easily spot the fakes and get them off the market promptly. Why did lipitor manufacturers make their packaging so easy to copy?
Anon has repeatedly pointed out (tnx) that the problem of adulterated products (actually another issue) will not go away just by banning reimports because more than 80% of active ingredients are manufactured outside the US. Perhaps finished product manufacturers in the US just might need to do more? FDA will probably insist they do anyway once reimports become legal.
nancy
Medication I get now comes from other country all ready. I remember
getting my medication for $2.00, after years, Went up to $3.00,
Then $5.00, 10.00, And the mail order was supposed to be cheaper
but started out $5.oo for 3months, Then 10.00, then they wanted
you to buy gernetic medication, If you didn’t you had pay the
differnce. The cheaper beginnig was pharmist at farmer Jacks,
Then went to Medco, now went CVs pharmacy, now $50.00 for
medication, Now going back to Medco. BuT I like going to
the Pharmacy than mail order. The reason medication keeps
going up to help others, and alot of my medications comes
from all over depends who has it.
We need go back making medication in United States not other
country, has hurt united states, and the american tax payers,
and in the end it has hurt the everyday person .