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Gothic Beauty

FDA Drug Approval Process

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Gothic Beauty

So I emailed the FDA the other day to see if I could figure out how much it costs to get a new drug approved. This is what I got:

Dear Ms. ******,

Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.

I can provide you with information about new drug application costs under the Prescription Drug User Fee Act (PDUFA)at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. There is no fee to file an investigational new drug application (IND) with the FDA. It will likely cost the sponsor a great deal to conduct the preclinical and clinical studies to be included in the IND and NDA. However, FDA does not collect any IND fees from the sponsor. The fees that FDA collects are associated with the Prescription Drug User Fees Act (PDUFA) and applies to New Drug Applications (NDAs), and are collected upon submission of the NDA to FDA: http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/default.htm.

PDUFA authorizes FDA to collect fees from companies that produce certain human drug and biological products. PDUFA established three types of user fees - application fees, establishment fees, and product fees. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process. Please find additional information about PDUFA at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm.

For information about general costs to conduct clinical trials, and for information about small business - large pharma relationships, I suggest that you contact PhRMA directly: http://www.phrma.org.

Best regards,

RL

Drug Information Specialist

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

I'm guessing that what this means is that all the "funding for research" does not really have anything to do with the FDA. The FDA basically controls what the price of the drug will be in the end when it's on the market. Just thought it was a fascinating tidbit to share. Any thoughts? Although this didn't really answer my initial question as to how much it would cost to get a new drug through the FDA process it did help a wee bit. I'm guessing that determining the cost for preclinical & clinical trials are up to the scientist's working on the drug sooo.... yea. Still trying to figure out an estimate so here's my question: "Not including the Dr./Prof.(s) salary who is working on the investigational new drug, how much would you think preclinical & clinical testing cost total? Does anyone really know?"

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accelerate the response

FDA drug approval, specifically phase three drug trial size, has little to do with science and much to do with litigation or the anticipation thereof. If a leading vaccinologist can stand up at an International Vaccine Congress and say that people are literally dying from conditions where the drugs already exist to treat them, but approval for clinical use is held up by the enormous costs and complexity of FDA approval, then there is a major scandal.

In his view, (Professor Ray Spier), the system should consist of a phase one, (ascending dose toxicity), trial and then an efficacy trial. On completion of that, it should be sufficient to license.

Phase three drug trial size he described as 'unscientific', which I take to mean that it is designed to meet potential litigation threats and not serve any scientific purpose. In may ways, the extraordinary potential length of what lawyers call 'the chain of causality' between a potential plaintiff and the originating event, as allowed by US law, is behind this state of affairs.

Many are the stories of such awards: the purchaser of a cup of coffee who spilled it on herself, sued and won because the cup did not say "Warning - Contents May Be Hot", is but one example. In the past, Judges could use the law to restrict such chains of causality using maxims like "reasonable foresight" to say, in the drinks case, limit the coffee vendors' liability by ruling that a purchaser could have been expected to 'reasonably foresee' that the coffee would be hot. Now, this seems not to be the case - i.e. the chain of causality is almost limitless with little to constrain it. Likewise, quantum of damages awards seem to bear little relation to the actual damage suffered.

When it comes to drugs, the potential damages awards are stupendous and so Pharma companies face several risks: research risk, that the drug fails in testing, as well as litigation risks - some very small group of recipients of the drug react badly and sue with awards likely to be so large that the company will be unable to meet them. Let alone the fact that a phase three drug trial for the FDA is likely to cost $250 million USD+ and so there must be a clear-cut market with potential sales in the billions to recover the development costs.

Reform of the drug approval process and the surrounding potential for litigation is absolutely necessary. Right now, the system is broken with only 23 new drugs approved last year by the FDA I understand.

The concept of 'volente fit injuria', a latin legal maxim, could be used to contain liability within fixed limits. 'Volens' means willing. If, say, a patient is told by a qualified medical practitioner that a drug falls into a category, (and I would see drug treatments categorised as low, medium and high risk by the FDA), and that there can never be absolute certainty but that it meets their medical needs and that there was a limit to potential compensation based on which category the drug was in, then, after signing a legal waiver accepting these facts, the drug could be administered. The patient was willing, ('volens'), to undergo the procedure and cognisant of the risk category he or she was in.

Only gross negligence that could be described as reckless in the face of all facts surrounding the drug known at the time of license, (rather than retrospectively applying new knowledge discovered after licensing), could provoke a higher award than the mandated maximum according to the risk category of the drug itself, (low, medium or high). This would also mean that the FDA concentrated on categorising drugs rather than trying to micro-manage the understanding of each and every treatment it came across, which may well be a better use of its doubtless limited resources.

By adopting these measures by Statute the drug approval process would be liberalised in a way that addressed research risk, (that a drug fails trials), by limiting the cost of the trials required to a sensible sum, and addressed litigation risk by applying mandatory compensation limits related to the risks of the drug itself according to the category assigned to it. Unlimited liability would be capped to cases of reckless negligence as described above.

In this way the drug approval process might facilitate drug development rather than inhibit it, as is the case now. In effect, right now, the system is as good as broken and in a state of paralysis. I hope the petition to Congress to reform the FDA processes described elsewhere on this website succeeds, however vested interests are enormous here and it would take a massive popular movement in the USA to overturn them and effect real statutory change.

And, of course, if all of this came to pass, it would...accelerate the response to HSV, and many other conditions besides.

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lovelyoptimistic

Completely makes sense accelerate! Never thought of it that way.

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Dummy
FDA drug approval, specifically phase three drug trial size, has little to do with science and much to do with litigation or the anticipation thereof. If a leading vaccinologist can stand up at an International Vaccine Congress and say that people are literally dying from conditions where the drugs already exist to treat them, but approval for clinical use is held up by the enormous costs and complexity of FDA approval, then there is a major scandal.

In his view, (Professor Ray Spier), the system should consist of a phase one, (ascending dose toxicity), trial and then an efficacy trial. On completion of that, it should be sufficient to license.

Phase three drug trial size he described as 'unscientific', which I take to mean that it is designed to meet potential litigation threats and not serve any scientific purpose. In may ways, the extraordinary potential length of what lawyers call 'the chain of causality' between a potential plaintiff and the originating event, as allowed by US law, is behind this state of affairs.

Many are the stories of such awards: the purchaser of a cup of coffee who spilled it on herself, sued and won because the cup did not say "Warning - Contents May Be Hot", is but one example. In the past, Judges could use the law to restrict such chains of causality using maxims like "reasonable foresight" to say, in the drinks case, limit the coffee vendors' liability by ruling that a purchaser could have been expected to 'reasonably foresee' that the coffee would be hot. Now, this seems not to be the case - i.e. the chain of causality is almost limitless with little to constrain it. Likewise, quantum of damages awards seem to bear little relation to the actual damage suffered.

When it comes to drugs, the potential damages awards are stupendous and so Pharma companies face several risks: research risk, that the drug fails in testing, as well as litigation risks - some very small group of recipients of the drug react badly and sue with awards likely to be so large that the company will be unable to meet them. Let alone the fact that a phase three drug trial for the FDA is likely to cost $250 million USD+ and so there must be a clear-cut market with potential sales in the billions to recover the development costs.

Reform of the drug approval process and the surrounding potential for litigation is absolutely necessary. Right now, the system is broken with only 23 new drugs approved last year by the FDA I understand.

The concept of 'volente fit injuria', a latin legal maxim, could be used to contain liability within fixed limits. 'Volens' means willing. If, say, a patient is told by a qualified medical practitioner that a drug falls into a category, (and I would see drug treatments categorised as low, medium and high risk by the FDA), and that there can never be absolute certainty but that it meets their medical needs and that there was a limit to potential compensation based on which category the drug was in, then, after signing a legal waiver accepting these facts, the drug could be administered. The patient was willing, ('volens'), to undergo the procedure and cognisant of the risk category he or she was in.

Only gross negligence that could be described as reckless in the face of all facts surrounding the drug known at the time of license, (rather than retrospectively applying new knowledge discovered after licensing), could provoke a higher award than the mandated maximum according to the risk category of the drug itself, (low, medium or high). This would also mean that the FDA concentrated on categorising drugs rather than trying to micro-manage the understanding of each and every treatment it came across, which may well be a better use of its doubtless limited resources.

By adopting these measures by Statute the drug approval process would be liberalised in a way that addressed research risk, (that a drug fails trials), by limiting the cost of the trials required to a sensible sum, and addressed litigation risk by applying mandatory compensation limits related to the risks of the drug itself according to the category assigned to it. Unlimited liability would be capped to cases of reckless negligence as described above.

In this way the drug approval process might facilitate drug development rather than inhibit it, as is the case now. In effect, right now, the system is as good as broken and in a state of paralysis. I hope the petition to Congress to reform the FDA processes described elsewhere on this website succeeds, however vested interests are enormous here and it would take a massive popular movement in the USA to overturn them and effect real statutory change.

And, of course, if all of this came to pass, it would...accelerate the response to HSV, and many other conditions besides.

This is excellent.. however, whats disheartening is.. Who's listening.. who's reading what we put out?? How do we get the attention of those that matter? Just too many folks that DON'T have this condition .. that sit at the top.. who don't give a damn..

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accelerate the response

D thanks very much. I am a UK citizen and so cannot really influence the FDA but I would hope that any patient advocacy group in the USA can take some or all of what I have written here or just use the concepts and lobby like heck, with your Senator, your Congressman, on-line petitions to The White House, letters to the FDA itself asking about reform, The American Bar Association etc etc. If I can make enough time I will be approaching the EMA (European Medicines Agency) and asking them what their future approval process looks like.

In the meantime, if I were a start-up pharma company looking to commercialise academic research into HSV I would look to license in the CIS (Russia) and then reverse that approval into the EMA or FDA process. They appear to have a far more pragmatic approach to drug licensing, (and no, I don't mean 'anything goes'), and costs are at least contemplatable.

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osten

Accelerate the response,

I totally agree. The FDA (and related European, etc) clinical trial process is an absolute travesty.

It's not even really about HSV at all. It doesn't matter who has this condition or doesn't. It's about the countless drugs that could get to market and help people, that never do, because of the current system. I think that, perhaps most critically, by stifling innovation and incentive, it's slowing down the overall pace of medical advancement. I shudder to think at what cost.

It sort of reminds me of that quote from the early days of the AIDS epidemic, "I came here today in the hope that my epitaph would not read that I died of red tape."

Once Phase I trials have assessed safety, there is absolutely no reason why people with informed consent should not be permitted to take drugs that may (or may not) help them. If it's safe enough to enroll a subsequent trial of hundreds, or thousands of people, it is safe enough for that.

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Dummy
Accelerate the response,

I totally agree. The FDA (and related European, etc) clinical trial process is an absolute travesty.

It's not even really about HSV at all. It doesn't matter who has this condition or doesn't. It's about the countless drugs that could get to market and help people, that never do, because of the current system. I think that, perhaps most critically, by stifling innovation and incentive, it's slowing down the overall pace of medical advancement. I shudder to think at what cost.

It sort of reminds me of that quote from the early days of the AIDS epidemic, "I came here today in the hope that my epitaph would not read that I died of red tape."

Once Phase I trials have assessed safety, there is absolutely no reason why people with informed consent should not be permitted to take drugs that may (or may not) help them. If it's safe enough to enroll a subsequent trial of hundreds, or thousands of people, it is safe enough for that.

True indeed.. I agree Osten.. Makes alot of sense.. very unecessary to go beyond safety and efficacy..

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