Posted on 12/07/2016 2:50:18 PM PST by oblomov
WASHINGTON—Passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to “cut red tape” at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation.
The Senate on Wednesday cleared the measure known as the 21st Century Cures bill, which lays out in detail speedier and more pro-industry methods for the FDA to approve new drugs and medical devices. Its supporters, such as PhRMA, the drug-industry association, and AdvaMed, representing device makers, praise it as a way to bring about more innovation and get treatments to patients faster.
Republicans have been pushing for the changes for the past few years, arguing that the FDA takes too long to study scientific evidence and sometimes wrongly insists on large, multiyear clinical studies that delay important treatments to patients.
The bill’s mechanisms allow the FDA to use shorter and simpler studies more widely. Under the measure, certain new antibiotics could see shorter trials, and a fairly wide range of drugs could get additional approvals for new uses based on relatively low amounts of evidence, such as data summaries and data from company registries.
Sen. Lamar Alexander (R., Tenn.), chairman of the Senate Health Committee, said the bill “will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the country.”
President Barack Obama said after the vote he would sign the measure “as soon as it reaches my desk.”
(Excerpt) Read more at wsj.com ...
But the legislation has drawn strong criticism from some medical experts and consumer advocates, who say the legislation in combination with the expressed views of Mr. Trump will amount to an unfortunate mix.
Who are these "consumer advocates" that want to keep new medicines out of the hands of patients? Just the usual statist Social Democrats who want to snuff grandma:
“We were already seeing weakening of FDA standards under the Obama administration,” said attorney Sarah Sorscher of the Public Citizen Health Research Group. She cited the recent example of the FDA approving a muscular-dystrophy drug that didn’t prove any benefit in outcomes of patients.
FDA needs total reform and downsizing.
There is so much movement between fda and drug companies - revolving doors - it is gross. Approve something under fda, then be hired by said company for a LOT of money, then eventually go back to fda, or after working for drug company to get approval, then hop over to fda to work, etc.
It is just sickening the unchecked quid pro quo crapola.
A boom for product liability lawyers I think.
‘weakening of FDA standards under the Obama administration’ - tell that to the 4 companies spending millions of dollars in the cleveland akron area the past 10 years -— oh wait one is out of biz now...
If we’re talking about someone who will be dying anyway without the medication, I say risk it. Let them have it. Give them a chance.
Across the board, this can be very problematic. I’m not here to defend the FDA, but even one bad mediation can cause terrible problems.
Rushing to market is not a good idea.
Thalidomide is a good example.
There again, after fully testing, studying the medication and certain promising indications, it was brought back to market. In some cases it is quite useful.
If FDA approves a product, then it is exempt from product liability litigation, unless the plaintiff can show that the new drug application to the FDA was fraudulent in some was.
This doctrine of “preemption” is a cornerstone of US regulatory law, for good or ill.
I believe that Apple wanted this legislation, to speed approval of medical apps and devices for the Apple watch.
Screw that long FDA process-adults do not need to be watched over by a nanny government using our tax money to do it-shorten the process, provide info of all the known benefits, liabilities, etc and let people have whatever drug they want to try-at their own risk after being informed-let the buyer beware, just like anything else...
I personally have never/do not use drugs-neither prescription or illicit, seldom use even OTC and prefer natural remedies-that is my personal choice. Let everyone else have their personal choice, too-they may well be better at making a choice that will heal them or save their life than some FDA official or even MD-no one knows themselves better than the person who lives in that body...
Agreed. Life-saving meds should be approved. Right now I’m taking Keytruda. Although FDA approved for some cancers, it is not approved for mine so insurance won’t pay for it and it is $16,000 every 3 weeks. Merck is providing it to me for free — compassionate use — because they believe it will help me. It is. It is working miracles for me and we expect a full remission after 7 years fighting. This drug could save tens of thousands of lives right now, but those poor people will likely die instead, waiting on clinical trials for “their” cancer test with the drug. It’s obscene.
I agree, and you are the exact person I was advocating for with that part of my comments.
There’s no reason the compassionate use path could not be used more for human trials.
If there’s no other hope, take the lifeline route. Death is a pretty bad outcome for non-provision, I’d say.
Best wishes for you. I hope this gives you complete victory.
Glad to see that you have new hope. God bless you
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