It seems that two house democrats have introduced a bill that would hold pharmaceutical executives criminally liable when they fail to disclose
evidence of serious adverse events related to their products.
The Pharmaceutical Research and Manufacturers Accountability Act (PhRMA Act), was introduced by Pete Stark (D-Calif.) and Marion Berry (D-Ark.), and
would impose stiff jail sentences and financial penalties on executives who knowingly withhold safety data. This legislation would also impose heavy
fines on drug companies that don't meet FDA requirements for postapproval studies.
Stark was quoted as saying: "It is unfortunate we need this legislation, but the only way to make manufacturers accountable for drug safety is to hit
them where it hurts — putting executives in jail and imposing large individual and corporate fines for wrongdoing."
The PhRMA Act can be viewed here
It seems like even the powers that be are tiring of the antics and profiteering that occur in the pharma industry at the expense of the consumer. It
will interesting to see if this bill makes it through both houses and is signed. I can imagine that the pharma lobby is going to spend some major
bucks stifling this one.
This bill might help to alleviate situations like this one
a biotech firm kept data from it shareholders about significant toxicity problems that led to a cessation of clinical trials.
It would further help to alleviate the burden placed on the judicial system by 'whistleblowers' who expose the collusion amongst the pharma and
medical to increase profits at the expense of the consumer. A brief list of such lawsuits can be found
. This site contains a good list of Pharma and other health
care related companies that have been sued by whistleblowers for substantial misconduct. It also contains links to the original news articles, which
Apparently, this type of thing goes on more than we'd like to believe: Taken from the
FDA's Devices and Diagnostics letter
(you won't be able to access the news
article unless you sign up, so I'll post what I've available.
Whistleblower Files Lawsuit Against HP, Agilent
A complaint was filed against Hewlett-Packard (HP) and its spin-off, Agilent Technologies, by a former employee, citing a "scheme to defraud its
customers by knowingly selling defective and potentially dangerous medical devices."
The lawsuit, filed by Robert Hindin on behalf of himself and the state of California in San Francisco Superior Court, estimates that over a six-year
period, from 1991 to 1997, HP distributed and allowed to remain in use thousands of such inferior medical devices.
The medical devices cited in the suit include Anesthesia Gas Monitors; Pulse Oximeters, and Ultrasound Imaging Transducers. According to the lawsuit,
HP had falsely certified to the government that it had complied with FDA requirements, including reporting each product failure, investigating these
failures and addressing the problems.
[edit on 28-2-2005 by mattison0922]