Wednesday, May 23, 2012

Shortage of meds is in the hands of FDA… until they get paid by Pharm Companies…


The Wall Street Journal  05/19-20/12 Thomas M.Burton

“Lawmakers To Vote On FDA Clout”


The Senate could vote as soon as next week on whether to give the Food and Drug Administration broader regulatory authority, including new powers to prevent prescription-drug shortages, inspect overseas drug facilities and more closely track medical devices for safety flaws.

Brand-name drug companies are expected to pay about $4 billion in user fees over the five-year law, an increase of about 6% from the current law. Medical-device companies would pay about $600 million over the same period, which is about double the current rate

Under the proposed legislation, the generic drug industry would, for the first time, pitch in about $1.5 billion in user fees to pay for faster product reviews. Also new are proposed user fees for companies making "biosimilar" drugs, or knock-offs that could mimic complex drugs such as erythropoietin for anemia, Remicade for rheumatoid arthritis and Herceptin for cancer.

Both the House and Senate bills would give the agency power to block products' entry into the U.S. if the FDA were refused admission to fully inspect facilities, and put the burden on companies to ensure the integrity of their supply chains. Also, the FDA would get the authority to fix a huge disparity: that U.S. plants are inspected about every two years, and ones overseas every nine years. The legislation would give the FDA broad discretion to focus on the most risky products, anywhere in the world.

The FDA has struggled to avert shortages of prescription drugs such as injectable drugs for cancer. The agency often doesn't know of production shutdowns that can lead to shortages until too late. The Senate and House bills would require manufacturers to notify the agency early on if they believe a shortage is about to happen.

Common Sense Review

So what I understand here is the pharmaceutical companies pay the gov’t for faster review of current products and the FDA says it is trying to prevent drugs shortages.

Sounds about right.. The simplified view is the govt is the pimp that gets paid and controls getting the product on the street.  

It is continually frustrating that the price and accessibility of drugs are dictated to the people when the govt in its infinite wisdom get tax dollars on the front and paid by drug companies on the back. 

When are the people going to wake up… the accessibility to drugs are not the pharm companies but the govt.   Our health in left in the hands of the govt official who will not allow a drug hit the market until they are paid… So when is our govt supposed to be for the people…

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