INTRODUCING THE PHARMACEUTICAL ACCOUNTABILITY (PHRMA) ACT

[Guest guest]

INTRODUCING THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS

ACCOUNTABILITY (PHRMA) ACT -- (Extensions of Remarks - February 16,

2005)

 

 

[Page: E252] GPO's PDF

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SPEECH OF

HON. FORTNEY PETE STARK

OF CALIFORNIA

IN THE HOUSE OF REPRESENTATIVES

WEDNESDAY, FEBRUARY 16, 2005

Mr. STARK. Mr. Speaker, people are dying because the drug industry is

making billions marketing drugs they know to be unsafe. Today I

propose a bill that will end this dangerous practice by increasing

accountability for pharmaceutical manufacturers and their executives

who withhold evidence of drug risks.

The Pharmaceutical Research and Manufacturers Accountability (PhRMA)

Act would impose criminal penalties and fines on those who fail to

disclose evidence of serious adverse drug experiences. 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.

In the past six months alone, Vioxx has been taken off the market for

causing heart attacks and strokes, and a new ``black box'' warning has

been added to antidepressants due to increased risk of suicide in

children. What's worse, evidence suggests the manufacturers knew about

these deadly safety issues, but masked or withheld the information

from consumers and the FDA because they were making so much money on

these drugs.

Profit before public safety is the modern mantra of pharmaceutical

manufacturers. These companies continued to market drugs that caused

individuals to be severely physically disabled or die. While the

companies have been civilly sued for their actions, their typical

response has been to pay enormous monetary settlements that don't even

put a dent in their outrageously high drug profits. Even worse, the

manufacturers never admit guilt and require injured parties to sign

non-disclosure agreements as part of the settlement, effectively

hiding from the public the horrific tales of death and disability.

The PhRMA Act will put an end to this irresponsible corporate

citizenship by placing responsibility for the knowing concealment of

serious adverse drug experiences on the pharmaceutical executives who

ultimately decide to place profits over people's lives. In the wake of

Enron and other corporate accounting scandals, the Sarbanes-Oxley Act

created 10-year prison terms for withholding financial information

from shareholders and regulators. The PhRMA Act would impose a minimum

jail term of 20 years and fines of up to $2 million on executives who

withhold information, proving once and for all that life is more

valuable than the almighty dollar.

The bill would also require CEOs to annually attest that they have

disclosed all evidence of serious adverse drug experiences to the FDA.

Failure to meet this requirement would result in fines up to $100,000

per month for the CEO and $1 million per month for the Corporation.

Under today's fast track process at FDA, drugs are often approved with

the caveat that manufacturers complete specified post-marketing

studies of safety and effectiveness. Unfortunately, drug companies

currently ignore these requirements because they know FDA will not

revoke approval of a drug unless it is clearly unsafe. This perverse

system actually provides an incentive for manufacturers to ignore

required post-marketing studies so there is no new safety evidence

available for FDA to justify a market withdrawal.

The PhRMA Act ameliorates this problem by requiring post-marketing

studies to be completed in a time-period specified by the FDA. Failure

to complete these studies can lead to fines of $5 million for each

month the study goes unfinished. As always, FDA retains the authority

to pull a drug from the market, but the PhRMA Act would give them an

important intermediate sanction to make drug companies accountable for

meeting their obligations.

The influence of the drug industry has infiltrated every aspect of

society. The Bush Administration gave drug manufacturers a huge

windfall in the Medicare prescription drug bill, the FDA bows to the

industry while ignoring the science, and millions are taking

unnecessary prescriptions because of TV commercials or doctors bribed

by manufacturers.

The PhRMA Act can begin to turn the tide on an industry that

continually puts profit and shareholder earnings above patients' lives

and health. By holding pharmaceutical manufacturers and their

executives responsible for the safety of their products we can ensure

prescription drugs save lives, not destroy them.

 

 

 

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