[Congressional Record (Bound Edition), Volume 151 (2005), Part 2]
[Extensions of Remarks]
[Page 2618]
[From the U.S. Government Publishing Office, www.gpo.gov]




       INTRODUCING THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS 
                       ACCOUNTABILITY (PHRMA) ACT

                                 ______
                                 

                        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 6 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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