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Post by seanismorris on Mar 10, 2017 15:16:41 GMT -5
O'Neill called for allowing drugs to be marketed after they had been proven safe, but before they had been shown to be effective.
O'Neill's views and Trump's recent comments that the FDA's approval process is “slow and burdensome”— despite data showing that reviews have accelerated — caused alarm in some quarters that the agency faced the kind of tectonic changes now affecting the Environmental Protection Agency.
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Post by kbrion77 on Mar 10, 2017 15:29:45 GMT -5
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Post by seanismorris on Mar 10, 2017 15:45:20 GMT -5
Right you are. I was reading another article.
I didn't catch the fact they switched to talking about (and quotes) of the guy that didn't get the job.
Quote:
If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also viewed as someone who would preserve the agency's basic function: to ensure that drugs are proven to be safe and effective before they are allowed to be sold.
Gottlieb does seem a better choice, but it's not very clear what would change under him... maybe accelerated approvals?
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Post by kbrion77 on Mar 10, 2017 16:05:36 GMT -5
Right you are. I was reading another article. I didn't catch the fact they switched to talking about (and quotes) of the guy that didn't get the job. Quote: If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also viewed as someone who would preserve the agency's basic function: to ensure that drugs are proven to be safe and effective before they are allowed to be sold. Gottlieb does seem a better choice, but it's not very clear what would change under him... maybe accelerated approvals? You read this and just say can it get any worse? She fast tracked and pushed through Opioids like candy and now we are facing an epidemic. She will never face charges against the clear serious conflict of interest between her and her husbands hedge fund. Just the world we live in. |
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Post by peppy on Mar 10, 2017 17:44:56 GMT -5
Looks to me that opiods are out
The FDA from 2009 to 2015 under Hamburg approved and expanded uses for a wide range of medications, including opioids or chronic pain medications, creating good news for many patients and pharmaceutical firms.
Cancer drugs are in.
Citing sources, Reuters reported Friday afternoon that President Trump is close to naming Scott Gottlieb as the next FDA commissioner. The news could come any moment, according to the wire service, resolving an issue that has huge implications for biopharma.
If the story holds up, Gottlieb’s nomination would be widely applauded by the biopharma industry, which would likely see the move as a commitment for continued reform without the kind of wholesale deregulation that would scuttle the agency’s gold standard for drug reviews.
As I reported two weeks ago, Gottlieb has mapped out an aggressive reform agenda in anticipation of this appointment.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He’s also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials.
Regime change.
Have you read the FDA approval of a cancer drug? here is a monoclonal antibody advertised on the news hour in the USA. probably one of the new class we read about. The name sounds good. www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf Other clinically important adverse reactions observed in up to 10% of patients treated with KEYTRUDA
were:
Infections and infestations: sepsis Ever see sepsis? takes you in hours.
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ican
Lab Rat
Posts: 28
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Post by ican on Mar 10, 2017 20:45:40 GMT -5
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Post by mnkdfann on Mar 12, 2017 15:09:07 GMT -5
Be careful what you wish for. 1. Would it really be a good thing if companies can market drugs for conditions not approved, and before they are proved to be effective? I suppose reasonable people might disagree on this. Personally, I'd like to have some assurance that a drug being marketed isn't snake oil or a placebo. 2. Say it happens, quite possibly (and I think likely) it would do more to help Mannkind's competitors than Mannkind itself. |
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