Should Americans Use Meds Approved In Europe First?
28 CommentsBy Ed Silverman // July 29th, 2010 // 8:54 am
Here’s a radical idea: Congress should amend the Food, Drug, and Cosmetic Act to allow Americans to use new meds once these are approved by the European Medicines Authority. Why? “Congress’s grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines,” according to a new report from the Pacific Research Institute, a conservative think tank. By amending the law, the contention is that regulatory competition would increase, patient choice would be expanded and lives could be saved for those suffering life-threatening illnesses without any options.
What about safeguard? John Graham, who authored the report, writes that the FDA would retain the power to compel drugmakers to label their meds with a warning that the FDA has not yet approved the safety or efficacy. And he suggests giving this idea a five-year trial run to see how it goes and then tweek any inadequacies. “This review,” he suggests, “might result in increasing regulatory competition even more by turning the FDA into a ‘certifier of certifiers,’ which would allow private-sector certifiers to compete to assess new medicines.”
To bolster his case, Graham points to recent approval data. During a 12-month period in 2008 and 2009, the EMA and the FDA approved a total of 39 new med. But 15 were approved only by the FDA, 11 were approved only by the EMA, and 13 were approved by both. In five of the 13 cases where the FDA and EMA both approved a drug, the EMA was the first to approve, and it issued those approvals 552 days faster than the FDA, on average. Even when including all 13 meds approved by both agencies, the EMA approved them 97 days faster, on average. “If the US government had allowed American patients to use new medicines that were approved by the EMA, but not yet by the FDA, American patients would have had faster access to 17 new medicines,” out of 39, he writes.
The notion is endorsed by Frank Burroughs, who heads the Abigail Alliance for Better Access to Developmental Drugs, which has lobbied for faster access to experimental meds. “How much power should the federal government have over patients’ right to choose medicines which might save their lives?” he writes in an intro to the report. “Graham’s research emphasizes the tragic loss of life due to the slow approval process at the FDA.” What do you think? Is this is a sound idea? Or a half-baked notion?
Should Americans Be Allowed To Use Meds Approved In Europe Before FDA Approval?
- Yes (55%, 121 Votes)
- No (45%, 99 Votes)
Total Voters: 220
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Jason
This is a poor idea for a number of reasons. The FDA and the EMA are friendlies, they work together and often review issues together (and not discounting other regulatory agencies who also work with them, like WHO, Canada, Japan, etc).
Having their combined input on drug development is a huge win for consumers.
The fact is, lives are not lost because a drug is not available. Lives are only saved when items are created. The loss of life is natural. It’s a positive step to find solutions, but it is incorrect to point fingers the other way around. It’s illogical and opportunistic, two issues that should be removed from the conversation when discussing helping humanity.
Mark
Wasn’t the reason why the US never saw any (or very few) thalidomide cases was that the FDA had it’s own approval process and demanded a higher standard than other countries?
Mark
Bernard Carroll
The “lives would be saved” mantra has a specious ring to it. For most anti-cancer drugs, for instance, the end point is not cure but delay of death. For most other new drugs the end points are symptom relief – maybe. For instance, Japan has approved milnacipran as an antidepressant but it has no apparent advantages over existing approved drugs in the US and it seems to be less efficacious. Allowing it into the US on the basis of Japan’s approval would do little to improve the US public health.
On the other hand, any truly impressive new drug will be quickly approved and will sell itself without crass marketing.
Christopher
Well, Burrough’s rhetorical “How much power should the federal govt have over patients’ right to choose medicines…” can be answered readily because until and unless independent certifiers (validated, qualified certifiers) are in place it’s the only option. I think the real question is whether combining resources of two closely aligned government bodies can improve access to new medicines and in a way that improves scrutiny, quality of review, pooled knowledge etc. (I mean EMA, not Japan.)
JiM might have a view on Mark’s thalidomide question but it’s worth remembering that at the time there was no EMA or combined European regulatory review, and that individual countries performed their own evaluations; obviously some better than others. The emergence of EMA from its previous incarnations has created a stronger regulatory body with pan-European authority. Adopting this proposal could further that across the Atlantic with potential mutual benefit.
Fascinating concept but tough to see how the politicians would make it work.
harpy
what is the benefit of “increasing regulatory competition”? why would we want “private-sector certifiers to compete to assess new medicines”? aren’t there already provisions for desperate people to obtain desperate medicines? and when was the last time a medicine came out that really cured anything?
Lynn
The EMA approved new medications earlier that have ultimately been taken off the market due to safety concerns.
none
This is the stupidist idea ever.
Just because the EMEA does their job ~97 days faster doesn’t mean that they are doing a better job than the FDA.
Only a politician would thing this
none
Frank Burroughs:
“How much power should the federal government have over patients’ right to choose medicines which might save their lives?”
I cant believe someone could be so ignorant… Better yet: let’s just disband the FDA altoghether and let consumers take whatever they want!
Idiot!
Salmon
Lies, Damn Lies, and Statistics.
Vigabatrin was approved for use in the US on August 21, 2004 14.25 years after it was submitted to the FDA on May 2, 1994 which was still 5 years after it was approved in the EU.
Also if you look at other drugs approved by the US in 2008 and 2009 it looks like many were pushed through after being hung up for a number of years e.g. tetrabenazine (submitted to FDA Sept 1995 available in EU since mid 1970’s). Rufinamide (submitted to FDA in Nov 2005). GADOFOSVESET TRISODIUM approved Dec 2008 complete response letter issued Nov 21, 2005 can’t find original submission date.
It looks to me that many of the drugs approved by the FDA in early 2008 had been having problems being approved for years and so there may have been political pressure to approve them before a new administration came in.
This also coincides with Janet Woodcock returning as head of CDER. Remember PHRMA was pushing for her to be the new FDA Commissioner under a new administration.
Salmon
Cynical
Just because it’s new doesn’t mean it’s better. Think Vioxx.
Outside the Box
I wonder about the long term merits of a combined FDA/EMA process whereby the agencies could work in collaboration, each taking responsibility for different types of drug (probably based on MOA rather than disease category, although this would be complicated). There would surely be savings in time and resources and the higher concentration of expertise should result in a higher quality process. Isn’t it the case that the two agencies now accept trials conducted on each others patch? True collaborative approval could be a next logical step - although jurisdiction, sovereignty, budget protection, job protection and just plain old politics will most certainly prevent this from happening.
Cassandra
Regulatory competition is one of the worst ideas I have ever heard — but I voted yes nevertheless, because I think that was the correct answer to the question that was put.
I don’t want FDA and EMA to compete, I want them to collaborate. I don’t see any justification for that duplication of work. The money saved can go towards developing a better approval process.
none
Outside the Box:
riiiiiight. And while we’re at it let’s combie our military forces too. Also, congress-parliment-president.
Collaboration is not likely.
Andrea
I must say that while our FDA is slow, the process is thorough. Without some major review, I’m not so sure about the EMA. At least there is some ability to control and mandate expectations by the FDA…we’d totally be out of the loop with the EMA and other regulatory bodies…much less COMMERCIAL entities!
We won our independence a log time ago, why give it away?
Justice in MI
Agree with Salmon–FDA is _not_ slow. In the stats cited, FDA approved more drugs sooner than EMA. And, indeed, the majority of new drugs (64%, I recall from Psaty) are now first approved in the U.S.
The approval time issue is a reflection of tortured statistics. This is the very tired, very old, and still misleading “drug lag” propaganda that made Newt’s career until he got busted for a version of self-dealing.
The real question is this: Is there _any_ evidence that any pts have seriously suffered
as a result of not having access to a specific med that was available in Europe?
And whatever that number that can be defended, how does it compare with the number who would have suffered if the drug _had_ been available a few days sooner in the U.S.
Anyway, the bottom line is that _we_ are the guinea pigs now. It is, indeed, not 1961 any more.
Justice in MI
None wrote: ‘ cant believe someone could be so ignorant… Better yet: let’s just disband the FDA altoghether and let consumers take whatever they want!”
That is precisely what Newt and the hard right argued in the 90s, and almost succeeded in accomplishing. Read Hilts on FDA.
They were helped by free marketeers like Milton Friedman. But, unlike his preemption progeny, Friedman argued that tort liability would be the “market force” that regulated the industry.
Christopher
Stats aside - because any can be found to support any argument - I’m not sure it is speed of review and approval that could be improved but the quality and thoroughness to be gained by pooling resources and harnessing expertise from a larger base of experts.
Similarly, it could be debated ad nauseam whether patients have suffered because of a ‘delay’, or indeed would have suffered had they received a drug sooner. With a more thorough review perhaps more of the right drugs and fewer of the marginal ones could make it to market. And, once approved, be monitored more comprehensively post-marketing.
pharmavet
Salmon is right. In fact, some US companies such as Forest Labs have as a business model licensing mediocre drugs that have been kicking around europe for a long time. Case in point is citalopram (Celexa), which is a Lundbeck drug, mediocre at best, which Forest turned into a blockbuster with good marketing. No thanks, I don’t Europe’s leftovers.
Christopher
Ignoring the rather myopic ‘Europe’s leftovers’ comment, I’m wondering what PV’s answer has to do with the question which concerns approval of new compounds, not the marketing of existing ones.
pharmavet
Christopher, to address your point, it used to be fairly standard for drugs to be approved in Europe before US. However, the engine of pharmaceutical innovation in Europe has greatly slowed over the past 20 years to where it has practically ground to a halt in both hemispheres. If we wait for them or vice verse, it will turn into an endless waiting game. On the contrary both hemispheres need to figure out how they can both greatly accelerate the pace of development and approval so that we can get drugs for unmet medical needs and get more life-saving drugs to patients much more quickly.
It is appalling that even under PDUFA the FDA has consistently failed to meet its time-critical obligations to get NDA’s approved more quickly. I would prefer to concentrate on fixing the FDA to get the NDA’s cranked out more quickly and not worry about what EU does. As far as I’m concerned I think way too many years were wasted on the the “Harmonization” proceess, essentially a busy work exercise that diverted attention from the regulatory mission of actually approving drugs. Prior to ICH, the rate of drug approvals was actually faster via the individual country route. To me it was a problem that didn’t need fixing.
Christopher
Thanks PV for the reply. There are some that would argue that pharmaceutical innovation in Europe has fallen behind that of the US, but probably few to none would argue that overall the rate of progress is disppointing. (Try this link for an interesting discussion on EU:US rates http://tinyurl.com/29ekyem)
Fixing the FDA is important but if resources are at the heart of it - including their availability and effective deployment - perhaps more could be achieved through cooperation.
I’m not supporting this hypothesis but it makes for an interesting discussion; I said at the beginning it won’t work for political reasons. However, if beyond resources, the quality of safety evaluations pre and post-marketing continue to be important, perhaps two heads would be better than one, so to speak.
Whether harmonization helped can also be debated, but regardless of whether more drugs were approved faster, the oversight made possible by a collective review may well have improved the quality of evaluations and that is what maybe the prize here, not quantity.
Christopher
Should have said “there are some that would argue your(PV’s) assertion that pharmaceutical innovation…” That omission made a difference.
Justice in MI
Back up thread, I think I got Salmon’s argument backward. Sorry about that.
I agree with Christopher that impact of FDA timing–within certain limits–is pretty hard to quantify re: both good and bad results for pts. And, yeah, each side finds what it needs. (Or, in lieu of data, finds stuff to make up–see again, Hilts…)
Also agree that joint ventures, not competitive ones, would be very good. My understanding (admittedldy based on the reporting of Gardiner Harris here) is that there used to be more of that before PDUFDA steered most of CDER’s funding to new drug review–that is, using collaborative data bases, and so on.
I understand that some of that has been restored.
Certd
One word:
thalidomide
pharmavet
Thanks guys. Great blogging with you. Gone fishin’ for awhile.
Ed, keep up the good work.
PV
Christopher
Certd: two words - read above.
Dan Abshear
It was my understanding that many drugs are approved in Europe before the U.S., anyway.
Doc
Thalidomide was definitely an issue, but metformin was available for years in the rest of the world before the U.S. - now it is the cornerstone of type 2 diabetes treatment.