June 10, 2012
Drug Approvals Faster In United States
Yale researchers find that the US Food and Drug Administration is faster than its Canadian and European counterparts when doing reviews for drug approvals.
Downing, Ross, and colleagues reviewed drug approval decisions of the FDA, the Canadian drug regulator, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. They studied each regulator's database of drug approvals to identify novel therapeutics as well as the timing of key regulatory events, allowing regulatory review speed to be calculated. Canada and Europe were chosen as a comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk..
Drugs reach the market in the United States sooner.
The team found that the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.
"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," said Downing. "The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews."
Downing added that most new drug therapies were first approved for use in the U.S. "Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S." he said.
I would like to see a much faster review process for drugs for fatal diseases. People who already have a diagnostic death sentence should be more free to try unproven drugs. If you get told you have just months to live the drug regulatory agencies can't protect you as much as they can kill you by preventing you from trying experimental drugs that are your last chance before checking out of the Life Hotel.
The amount of duplicated work between those 3 agencies must be staggering.
Only governments would spend their money that inefficiently.
The 2 less efficient ones should outsource to the FDA, and all 3 groups would save billions every year to spend on new research.
Why not just replace drug regulation by mandatory reporting of drug use consequences and vigorous prosecution of fraud?
It looks like this study analyzed the amount of time it took once the application was submitted.
However, the application may be submitted years earlier in Canada and EU as compared to US because the regulatory standards are easier to meet in those markets. If this typically the case for drugs? I know it is for medical devices.
Placebo wrote, "I know [regulatory standards are easier to meet in Canada and the EU than in the US] for medical devices."
This is definitely correct.
Marry in haste; repent at leisure.
Applies here, too, mutatis mutandis.
Mthson: Some drug approval agencies for other countries (I will not name them) basically do wait for FDA to approve a drug and then say "what they said" and approve it in their country.
Placebo: I think that the regulatory standards ARE higher in the US than for Health Canada and EMEA. But products appear in those jurisdictions earlier than the US because they make their applications there before here (US).
Future Pundit: you CAN get experimental drugs for free in the US, for life-threatening problems or mere jock itch. You just have to participate in a clinical trial during which the drug company keeps score to see if it helps anyone, and if it hurts anyone. If the drug "passes", then the FDA approves and then you can buy it for whatever the maker chooses to charge. But before that approval, drug companies are usually more than eager for you to get their experimental drug while participating in the IND (Investigational New Drug) application process. If anyone could make anything and make any claim about its utility and charge you for the privilege of using it, wouldn't you want someone with an independent lab and clinical expertise to tell you if it was sterile (if to be injected), whether it was what it purported to be, what the side effects where going to be, and whether it would make your cancer go away, and better yet, that you would actually live longer for taking it? Wouldn't you then re-invent the FDA or its equivalent?
Guessed wrote in part:
"If anyone could make anything and make any claim about its utility and charge you for the privilege of using it, wouldn't you want someone with an independent lab and clinical expertise to tell you if it was sterile (if to be injected), whether it was what it purported to be, what the side effects where going to be, and whether it would make your cancer go away, and better yet, that you would actually live longer for taking it? Wouldn't you then re-invent the FDA or its equivalent? "
Not if you wanted freedom to apply your own attention and judgement, and that of whatever healers you consult, to what you use to sustain your own life, no.
Guessed wrote a series of sentences that assumed every class bigot fantasy about businessmen who produce medicines. Those businessmen don't want a rep for killing their customers, especially since customers family and friends *do* remember, and tell their other friends as well!
The simple fact is that even the FDA's lesser delay than its foreign equivalents is killing far more people today than it is saving. They are doing it in service to the class bigotry that says businessmen must be continually overseen, or they will defraud/destroy everyone else. They are doing it by prosecuting people who do not wait the years for FDA bureaucrats to screen their medicines, while those bureaucrats would be costing the producers an average of $850,000,000 for each medication approved. They are doing it, knowing that it will force small drug developers to first develop a drug, and then sell out to the few remaining large producers *as*a*norm*, because the small companies cannot finance those $850,000,000 worth of tests.
Even scaling the FDA back to only testing for safety would be an enormous improvement in costs and speed of delivery.
Even this will go by the boards eventually, when genome testing becomes cheap enough that people can know what design of drug or medical equipment will work best *for*them*as*an*individual*, with the least side effects. Once that happens there will be millions of new drugs to test every year, which is utterly beyond the ability of the FDA to regulate. That, of course, is why the FDA is trying to squash the sale of genome testing kits, which are one of the markets driving down the cost of genome testing.
No Guessed, I would never want to re-invent the FDA. Let it die, before it kills me, and many more like me.
T Billings: I actually work with people who develop drugs and put them through clinical trials. I make NO assumption about any of them. For the most part they are fine people and do their best, and I have been pleased with the results of the drugs they are developing. Some are more fastidious about their data than others, and some work hard to get me to say good things about their products. I don't think pharmaceutical manufacturers are necessarily any better or worse than any other kind of businessman.
If you think that people or businessmen value their good name above profits and don't want to be associated with bad products, why do we read on a weekly basis about someone injecting silicone into women's butts in hotel rooms and killing them? You can say that they aren't "real" businessmen or developing "real" drugs, but if you want no regulation, then what these people do will be just as legitimate as any regulated Big Pharma venture now. There is no small amount of counterfeiting of legit drugs that are probably harmless (aside from economic loss), or even harmful. Why would the Chinese not care about killing our patients with their defective (contaminated) heparins, or melamine/arsenic/toxin containing baby formula or pet foods. Things they sell not only to us, but to their own people? Even reputable drug companies have products with issues that come to light after approval. Maybe you trust self-interest and self-regulation to carry the day, like our banking and financial services sector has shown. Enlightened self-interest and all that. Funny how that didn't work out so well.
I personally think you should be free to do anything you propose. However, I predict that if we went with a libertarian approach to regulation, the FDA would be re-invented by private market sources, much like Underwriters Laboratories, or the like. It might not even be a government body, but I bet its core functions would be re-created pretty quickly by people who want to get an opinion that is independent, not just BS testimonial crap on a web site from company puppets.
The reason the FDA bar is so high is not because the FDA necessarily wants to raise the bar. Every time there is a health disaster of some sort, there is a public outcry to "do something", Congress picks up the ball and "does something" (pass a law), and at the end of the statute comes the enabling legislation that permits/requires FDA to make regulations to enforce the law.
I agree that the cost of regulation is too high. So lower the bar, all you want. That is a political decision. The politicians decided that vitamins and nutritional supplements were not to be regulated by the FDA, and the FDA therefore has nothing to do with them. And not much bad seems to have come of it, good or bad. That is probably because vitamins and nutritional supplements are just not very potent, compared to most drugs. There have been no outbreaks of deaths related to vitamins or supplements (except for some bad tryptophan that caused muscle breakdown), and for that matter, no cures for cancer that have been "suppressed" by the establishment have come to light.
The sale of genome testing kits should be allowed. Have at it. But nobody selling them should be allowed to make claims (lie) about their accuracy without demonstrating that they are accurate. If you have a genome of 3 billion base pairs, and sequence it with 0.001% error rate, you have a built in error rate of 30,000 bases mis-called. More than a few of the 30,000 errors will imply a disease that you don't even have, but if you want to go that route, feel free to do so. I have patients in my practice who were told that they were carriers for bleeding disorders on the basis of DNA testing, and the measured clotting proteins were perfectly fine. I predict that as genome sequencing gets to be more widespread, and more people use it this issue will be quite common, and someone will ask Congress to "do something". And they will. Just like CLIA to regulate clinical labs in 1988. You, personally, may not ask for it, but the American peole will do so, mark my words.
The FDA exists in its current configuation because the American people through their Congress, asked for it to be that way, whether they know it or not.
One reform I would advocate for clinical trials. Instead of always comparing with placebo, allow trials that compare with the standard current treatment. Then see which treatment helps best. I think that would produce better results, and it would solve an ethical dilemma in clinical trials, where the people getting placebo have their conditions get worse, because they are not receiving standard tretment.
Richard40: Most Institutional Review Boards (IRBs) that oversee the conduct of clinical trials at universities or clinical research centers (VA, county hospitals, NIH, private hospitals, etc) will not permit a trial where the standard of care is withheld so a drug can be tested against placebo, where there is some accepted standard of care. If there is no standard of care, then comparison to placebo is considered acceptable (in fact preferable). If it is a minor illness where it is not critical that the patient recieve the standard care, it may be appropriate to randomize patients to the new drug or the standard care, without knowing who got what, then switch to the standard care in the absence of improvement. If a drug works better or as well as the standard care, then it may be approved based on non-inferiority. You don't have to be better than the standard care, just equivalent.
If you look at the label (package insert) for approved drugs that have been compared to placebo, it is remarkable how many people have side effects with placebos, and how many show some improvement with a placebo. Which is why it is hard to prove new drugs work or don't work. Drug development is damned hard work, and the low hanging fruit has largely been picked already.