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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