The amount of time necessary to move a new medication
from the research lab to the marketplace is a subject of great
debate. Drug makers argue the U.S. Food and Drug Administration
is too cautious, making the organization inefficient and subsequently
driving up drug costs. Consumer advocates say the opposite; that
the FDA review process is inadequate and that industry pressure
and limited resources have allowed dangerous drugs to enter the
market.
In the early 1990s, as the world became increasingly
aware of the threat from AIDS, there was great political pressure
to bring AIDS and HIV-related medications to market quickly. Congress
ordered the FDA to work with the pharmaceutical industry to accomplish
this goal.
As a result, the FDA began giving “fast-track
approval”
to certain new drugs. Drugs on fast-track went through the approval
process in half the normal time – one year instead of two.
And where only four percent of the new medications submitted for
FDA approval in 1988 eventually found their way to a pharmacist’s
shelf, by the end of the 1990’s the agency was approving
fully 80 percent of such new applications.
It was no surprise then that numerous patients
began developing an array of life threatening illnesses from drugs
that were approved on the fast track. Between 1998-2001, the FDA
recalled 10 drugs, and the American public began to wonder whether
the agency cared more about boosting big drug makers’ profits
than it did consumer safety. Media reports that the pharmaceutical
industry paid for more than half of the FDA’s costs for reviewing
new drugs made the situation worse. Critics also questioned whether
the fast-track system allowed enough time to thoroughly test the
drugs BEFORE they went to market, and whether American consumers
had become “guinea pigs.”
Now under new leadership, the FDA is backtracking
and drug approvals have declined to the lowest rate in a decade.
Whereas in 1997 the FDA approved 120 new medicines, by 2002 the
number had dropped to only 54. The agency cites increased testing
of drug-to-drug interactions and greater scrutiny of each new application.
Additionally, many medications submitted are variations of drugs
that are already on the market, rather than completely new drugs.
It’s too early to tell if the slowdown in
FDA approvals has translated into safer drugs. Regardless of the
FDA’s standards, it’s always a good idea to talk with
your doctor about any medications he or she prescribes for you.
Make sure you have an answer to any questions or doubts that you
might have and if necessary, do some research on you own via the
Internet or even by reviewing medical journals.
By law, drug manufacturers can be held liable
for injuries caused by a defective or unreasonably Dangerous
Drug Product, even if the manufacturer was unaware of the danger.
At The Rasansky Law Firm, we work to help victims who sought to
improve their health, but instead were injured by the very drugs
they relied on for relief.
If you or a loved one has suffered due to the
effects of a Dangerous Drug or
an Over The Counter Drug,
please contact the Rasansky Law Firm to look into your potential
claim.
