How to Speed Up the Drug Approval Process
Unless you are an asthma sufferer, you probably didn’t see the Food and Drug Administration’s (FDA) recent announcement that beginning next year it will ban the sale of Primatene Mist, the only over-the-counter asthma inhaler sold in the United States.
Do new tests show that the drug is harmful or that there are unanticipated side effects? No. In fact, Primatene Mist has proven to be one of the most effective treatments for temporary asthma symptoms. Instead, the drug is being pulled for environmental reasons — yes, you read that right. The only over-the-counter asthma treatment will no longer be available because of an international agreement created to stop the substances that damage the environment. Because Primatene Mist uses chlorofluorocarbons (CFCs) as a propellant (spray), the medicine is considered an atmospheric pollutant.
Not only is this a heavy-handed response by the feds, but it could actually be dangerous. Rather than put the needs of asthma sufferers first, this FDA action will require patients to pay more for alternative medical treatment and limit the likelihood that temporary asthma symptoms can be treated quickly and effectively.
For patients without medical insurance, this decision could likely lead to black-market purchases or an increased willingness to use stale-dated products. This is far more dangerous than the effects of the inhalers on the environment.
However, such decisions demonstrate that the FDA has gone far afield from its responsibility to ensure that efficacious drugs are efficiently approved for sale in the U.S. In fact, it really is time to consider reforms to the FDA like the Heartland Institute’s Free To Choose Medicine (FTCM) initiative.
How does Free To Choose Medicine work? FTCM makes an end run around the costly and time-consuming FDA reform approval process — a process that in some instances is approaching 10 years. While providing modest safety protection, the longer approval times give little comfort to a patient with a terminal condition. In fact, there are literally hundreds of cases where a drug that would ultimately prove safe and effective was denied to patients — and tragically, the patients died before getting access to the drug.
Free To Choose Medicine relies on a two-tiered system. One tier keeps the status quo for any who still believe it is useful or effective. A second tier relies on an innovative waiver approval process whereby patients with either a terminal diagnosis or a chronic illness are allowed to access drugs that have already been submitted to the FDA — well before their formal approval would occur in the first tier.
Speeding the process would certainly make the tort lawyer’s job in court easier! Might speed the front end approval up, the tort attorneys would remove it on the back end. Any time a natural death occurs to anyone taking the medication, the med will be blamed for the death. Maybe start the process by eliminating the tort scum.
Exactly right. This plan will not last long – the first lawsuit will sink it.
Get tort reform accomplished, and we can fix a lot of other things that cannot be fixed now.
If someone dies because they can not get an inhaler, can that persons family sue the FDA.
Mr. Cooper:
“Ultimately, America can’t afford to have a health care system where it is acceptable to let people suffer or die needlessly due to delay in receipt of drugs.”
Gee…I’ve heard this schlock before! Now where and when did I hear it… oh, that’s right! I heard thuis exact same song and dance from the “ACT-UP” crowd in the late 1980′s and early 1990′s!
Yeah…back then it was all about “fast-tracking” experimental drugs for AIDS patients who would DIE because of FDA’s “slow-belling”. And as I recall, they got their way and FDA fast-tracking was established.
But wait a minute, ace. Here we are 20 years down the pike, and the treatment for people with HIV is the EXACT SAME “AZT cocktail” that it was in 1991.
So, exactly WHICH drugs got “fast-tracked”? I suggest giving the folks at Sokolove Law Group a call to find out…their number is 1-800 BAD-DRUG.
Or maybe you can ask the poor schlubs who took Accutane for acne, and who now can’t defecate correctly from the side effects.
This is the kind of thing that FDA should find out about BEFORE the drugs are released to the market, not AFTER.
But then along come folks like you who are flacking for Big Pharma, either consciously or not, who whip up the herd to yammer at the bureacrats.
By all means, put the boot into FDA when they go off their narrowly defined mission and try “saving the Earth”, but do this in order to get their minds right with doing the job they were instituted to do, NOT to bulldog them into being a rubber-stamp so that Snake-Oil Inc. can profit from foisting toxic compounds on the unsuspecting public.
Your recycled “ACT-UP” song and dance might enrapture some of the weaker-minded hereabouts, but I heard this number before from the original cast the first time it opened.
There’s no such thing as a safe drug–period. People like you scream that Pharma and the FDA are supposed to eliminate 100% of risk. However, the ONLY way to eliminate 100% of risk is to stop making drugs altogether. Thanks to screamers like you, that is about to happen.
The only way to speed up the approval process is to send in the payoff to the FDA before your submission request for approval.
The FDA is NOT what it once was. Today, it is a government front for revenues. If you don’t ‘submit’ an offering adequate for the FDA to be “interested” you will be turned down or put at the very end of the line. That means more than 10 years of continuous bribes, counter bribes and ‘fees’.
Once your company has been adequately ransacked for ‘capital’ you most likely will be turned down.
They already took the CFCs out of Albuterol, the main rescue inhaler for asthmatics. Unfortunately, the substitute propellant, while environmentally correct, does not work as well. The inhaler now must be used with a “spacer,” essentially a carburetor for your medicine. These are bulky items usually left at home, while the old rescue inhaler could be carried everywhere. Like so many Green products, this one costs 3x as much while performing much worse.
Megan McArdle wrote about this some time ago. From her account of the testing and approval process, it is evident that the FDA determined the politically desirable outcome in advance. The testing was reverse-engineered to yield the desired results. Consider this a preview of political medicine under Obamacare.
http://www.theatlantic.com/business/archive/2009/05/the-patients-are-the-problem/17578/
Following the good post by #5. The CFC thing is all junk science to start. At its peak, 2500 tons of CFC’s were manufactured and almost all used as refrigerants. Supposedly this destroyed ozone, O3, in the higher level of the atmosphere, but only if in contact on a surface on which to react. Roughly one third of this could actually become “free chloride ion” or about 1000 tons maximum.
Meanwhile the oceans are in a balance that in response to sunlight and many of the active biological processes, releases an estimated 600 million tons of free chloride ion…unregulated by the enviro whackos.
Interestingly enough, DuPont opposed this particular environmental idiocy until its patent ran out on the CFC’s….guess who owns the patent on the HFC’s at now 20 times the price with 60% of the effectiveness. +
Bingo!
Sorta like how we couldn’t have halogen headlights until patents ran out and GE was able to start making them…
So why doesn’t California allow “Medical Inhalers”, that could be manufactured in-state for the relief of this horrible medical condition. They could make a *mint* by running the taxes up on them, and 56 other states would be more than happy to mail-order them by the ton.