Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, August 20, 2015

Forbes: FDA Approval MEANINGLESS!

The FDA Is Basically Approving Everything. Here's The Data To Prove It

Matthew Herper  AUG 20, 2015 @ 5:53 AM 
Remember when the FDA rejected drugs?
We just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.
As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.
Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.
The way BioMedTracker follows new molecular entities is slightly different from the FDA does. BioMedTracker users want to know about every use of a new medicine. That means that the 2015 rejection count includes rejections of Avycaz, a new antibiotic from Allergan ngIf: ticker AGN -1.27% ngIf: show_card end ngIf: ticker , for hospital-acquired pneumonia, and selling Jardiance, a diabetes drug from Eli Lilly ngIf: ticker and Boehringer Ingelheim ngIf: ticker , in combination of metformin. But Avycaz was approved for two other uses and Jardiance is on the market by itself.
So in reality, the FDA approval rate is more like 96%. Eliminating BioMedTrackers counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ngIf: ticker ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.
But it’s worth sticking to BioMedTracker’s definitions, because it allows us to compare this incredibly high approval rate with the past. And that tells a story of an agency that has been giving the green light more and more often.

In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%. In 2009, the NME approval rate fell to 44%, as 28 uses were rejected and 22 were approved. That rate rose to 86% in 2011, partly as some of those rejected drugs reached the market, fell again to 60% in 2013, and in last year rose to 88%. The evidence is that we’re living in a golden age of drug approvals, at least from a drug company’s perspective.
And there’s even more data to back up the contention that the FDA is basically providing a rubber stamp. BioMedTracker doesn’t just track what happens to NMEs, or new drugs. It follows closely every time a company asks the FDA for an approval. (One flaw in the data: while drug approvals are a matter of public record, we only know about rejections, known by the euphemism of “complete response letters,” if drugmakers feel the need to share them publicly.
For this analysis, BioMedTracker also looked at every time that a company asked the FDA to either approve a new drug or approve a new marketing claim for an existing medicine. The numbers parallel what was seen with brand new medicines.
In 2008, companies asked for 134 approvals and got 75 of them, a 56% approval rate. That rate hovered steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%, with 97 out of 126 requests for approval coming back positive. This year’s approval rate? It was 88%.
Again, nine out of ten times, when a pharmaceutical company asks the FDA for a new marketing claim, it gets it. That’s why all of the arguments about Addyi, whose maker, Sprout Pharmaceuticals, is now being bought by specialty pharma giant Valeant Pharmaceuticals ngIf: ticker for $1 billion, were a little silly. The odds of a rejection were low at best.
The FDA points out that one reason that drug approval rates are going up is because it is doing its job, as defined by Congress. The agency has deadlines for when it is supposed to approve new drugs, and it is meeting them. More than that, it has instituted new procedures to make sure it communicates well with drug companies before they file new drug applications. And the FDA has had a program to ask patient advocates what they want. Many sick patients would prefer that the FDA approve a drug with a marginal benefit than reject it.
Right now, it only looks like this trend will continue. A new bill called the 21st Century Cures Act attempts to further speed up approvals and remove red tape.
But the risks of speeding up approvals should be pretty clear, too. In the late 1990s and early 2000s, there was a boom of new drug approvals. In 1999, the FDA approved two drugs that became synonymous with drug safety scandals: Vioxx, which was withdrawn from the market by Merck, and Avandia, made by GlaxoSmithKline, which later had its use severely restricted. The approval boom is good only so long as it doesn’t trigger another drug safety conference.
That’s why we should tread carefully here. Already, the FDA is approving drugs almost all the time. It is doing so rapidly, with appropriately lower standards for rare diseases. How low do we want the bar to go?
And it seems appropriate to also give a warning to biotechnology investors. For any drug facing an FDA decision in the near term, this is good news. Worried about whether the muscular dystrophy drugs being developed by Sarepta and Biomarin will be approved? The odds are probably better than you think.
But we’re also living through an unprecedented biotech boom, with the iShares Nasdaq Biotechnology Index up 360% over five years in part because the regulatory environment for drug companies has improved. Well, this could be as good as it gets. If 96% of new drugs are getting approved, approval rates can only go down. If you’re looking for an indication that we’re hitting a peak, this could be it.
And I think it’s likely that the current approval rates are as much a result of the political environment as anything else. To the extent that they think about the FDA, politicians on the right generally want the FDA to get drugs to patients faster, giving them choices. Those on the left worry more about approving dangerous drugs.

But the FDA doesn’t follow the tone set by the President or the party in power, because the FDA is never the center of anybody’s agenda. Instead, its tendency, even if its unconscious, is to protect itself against attacks from the opposing party. A lame duck Democrat and a Republican Congress? You’re going to get an easy FDA. If a Republican wins the White House next year, think about selling your drug stocks.

I posted the article on my Facebook page with this comment:  

Thank you, Helen Haskell for sharing this article. I was trained 9/2010 at FDA/CDRH to be a Patient Representative. I have NEVER been contacted to serve on an AdvisoryPanel. Patient Representatives are NON-VOTING and most devices are cleared as 'substantially equivalent' 510(k)-grandfathered. I would like to see a similar report on medical devices and have a requirement that this information be a part of 'Informed Consent' for the patient.

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