The Justice Department says the
corrupt FDA chemist (Cheng Yi Liang), who worked in the Office of New Drug
Quality Assessment, traded on multiple occasions by using non-public
information obtained through the agency’s password-protected internal tracking
system for new drug applications. Liang made nearly $4 million off the deals
and recently reached a plea agreement with federal prosecutors. This week he
was sentenced to five years in prison.
Perhaps the FDA will find a way to
keep him on its payroll. A few years ago a congressional report
exposed that government scientists convicted of felonies are allowed to conduct
essential drug and biologics research because the FDA doesn’t bother removing
them, even though federal law demands it. This means Liang may very well get
his job back after he’s done serving time.
His case is simply the most recent
of many controversies to hit the federal agency responsible for protecting
public health and safety. In the last few years the FDA has been embroiled in a
number of transgressions, mostly involving its failure to enforce federal laws
to please wealthy pharmaceuticals that pay hundreds of millions of dollars in
“fees.”
In fact, the appalling arrangement
has even been documented in various federal probes. One scathing congressional report outlines in detail how the FDA allows companies that
annually pay it more than $400 million in fees to compromise public safety.
Judicial Watch has exposed one
deadly example—Gardasil— that was fast-tracked by the FDA to protect against
cervical cancer. JW uncovered droves of government records listing thousands of
adverse reactions associated with the vaccine, which is manufactured by
pharmaceutical giant Merck. They include paralysis, convulsions, blindness and
dozens of deaths. Based on the records JW published a special report detailing Gardasil’s approval process, side effects, safety
concerns and marketing practices.
JW has also exposed FDA secrecy. A
few years ago JW reported how the agency avoided publicly
disclosing information about an approval
process by rebranding the product for veterinary use. It involved the first
genetically engineered animal for human consumption—genetically modified
fish—and the FDA wanted to keep the gory details from Americans who would eventually
it
Reflections
1.
What is the link to
Crisis Management?
A chemist working for the US
regulatory body Food and Drug Administration (FDA), has been found guilty of
insider trading. This employee used information that he gained through his work
at the FDA to make millions of dollars and has now been sentenced to five years
in prison.
2. What stage of Crisis Management does the system appear to be
at?
This situation is a risk for
the FDA because it makes them look like they did not do their due diligence to
stop something like this from happening. This is also a risk for the public
because they expect the FDA to approve drugs that are safe without worrying
about unsafe drugs and products being passed by the FDA just to make money.
3. How well does the system appear to be handling the
situation?
The FBI has been involved in
investigating crimes such as these but these are all reactive measures. The FDA
has strict measures in place to ensure that insider trading does not occur but
this situation has caught them off guard. They have not made a public statement
about this story which also calls into question other practices such as branding
a product for animal use in order to avoid public disclosure.
4. What level of crisis preparedness does the system appear to
have?
The FDA does not seem to
have a lot of crisis preparedness as most of their rules try to prevent
something like this from happening. One such rule is that employees must
disclose their earnings to the FDA on a yearly basis. In this case, the employee
used his family and friends’ accounts to hide his income. The FDA should
monitor their employees more closely and should also be more transparent as an
organization to avoid a crisis situation. Furthermore, they should have a crisis
communication team in place that can respond to the media if a situation like
this does occur.
5. What personal reactions/feelings does the description
trigger in you?
I feel that the FDA needs to
be a more transparent organization as they hold the safety of the public in
their hands. Being a regulatory body, they need to keep the pharmaceutical
industry in check and ensure that no unsafe products reach the public. The
story speaks about Gardasil being approved by the FDA for monetary gain even
though it was unsafe for the public. This triggers anger and fear in me as the
story insinuates that the FDA was aware of adverse side effects but still approved
the drug. I feel that regulatory bodies are in place to protect the public’s
interest and should be not-for-profit organizations whose sole goal should be
to protect the public.
6. What advice would you offer to those involved?
The story speaks about the
FDA re-hiring scientists that have been found guilty of transgressions. I would
advise them to do stringent background checks on future and present employees
and to put the safety of the public first.
I would also tell them to have a crisis management team in place so that
they can address situations that may occur in the future. They should also have
a crisis communication team in place that informs the public of their protocols
that protect the public from unsafe products. They should be more transparent
and assure the public that they do not accept fees from pharmaceutical companies
by compromising their regulatory responsibility in keeping the public safe.
