Wednesday, February 1, 2017

Who really wants to blow up the FDA? Not the drug industry

Health Train Express is following the issues that POTUS is addressing in regard to health care.

Following his not too surprising nomination of Tom Price for the head of HHS, he now turns his attention to another big player, the Food and Drug Administration.  While the FDA plays a major role in the safety of food products in the United States, not much is said about that during political campaigns or in decision making.  It's role in pharma, medical devices, and now mobile health applications draws headlines.

What most industry reporters usually mention is the length of time and the expense of developing new drugs, and how that contributes to increased drug costs.



President Trump has repeatedly said that the FDA needs to be overhauled. He’s talked about speeding up drug approvals and reducing regulations — he’s vetted possible FDA heads who want to put drugs to market before we know they are effective. But, outside the White House and Capitol Hill, is there anyone who agrees with this? STAT’s Damian Garde takes a look.


Trump has big plans to fix drug prices. Here’s your reality check

Eli Lilly has raised the price of insulin more than tenfold since 2001 and is now facing a class-action lawsuit and threats of a congressional investigation.
Amgen has repeatedly raised the price of Enbrel, a blockbuster anti-inflammatory treatment that has been on the market for nearly 20 years. The price of J&J’s competing Remicade rose by 63 percent between 2011 and 2016.Since 2010, Merck has raised its drug prices by more than 9 percent on average, and Novartis has increased the price of the cancer drug Gleevec from $26,400 in 2001 to more than $120,000 this year.
There have also been cases where drug prices have acutely skyrocketed, in come cases over 1,000 %.  drug for treating pinworm, an intestinal parasite was sold for $ 3.00 a dose, and now costs $ 300.00 dollars. Anthelmintics, such as mebendazole, pyrantel pamoate, and albendazole, are active against Enterobius vermicularis.
Mebendazole is now being studied as a drug to prevent cancer. (coincidence, or opportunistic ??
His pledges, which will need to be fleshed out, would likely require work from the Food and Drug Administration. Trump also said Tuesday that he would soon appoint a commissioner to lead the agency.
The industry, for its part, has rolled out an advertising campaign backed by tens of millions of dollars to burnish its public image. Industry officials described Tuesday’s meeting with Trump as a chance to get in the door with the new president after his incendiary comments. Depending on the time of the year, and politically expedient slogans pharma can change it's mantra.  
Late in 2014, the Amgen announced their original restructuring plans to reduce payroll was too modest, upping its goal on job cuts to 4,000. And the pharma giant followed up in the spring of 2015 by axing about 300 staffers after Bradway decided to shutter the Onyx campus obtained with its acquisition of Kyprolis.

Trump confronts big Pharma on Pricing


On Tuesday, though, Bradway became a job creator.
“We’ll be adding 1600 jobs at Amgen this year,” he told President Donald Trump, minutes after the president had finished a harangue about the new American jobs he expected in exchange for reduced regulations.
It may be unwise to paint the whole of pharma with the same accusations.  Politicians focus on the "outliers" to prove a point.  Readers should carefully consider the source and not take pronouncements at face value.
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