CONGRESSMAN PETE STARK 239 CANNON HOB, WASHINGTON, DC 20515 (202) 225-5065 http://www.house.gov/stark

THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS ACCOUNTABILITY ACT 0F 2005

Introduced February 16, 2005

Reps. Stark and Berry

- BILL SUMMARY -

OVERVIEW

Over the past decade, it has become apparent that the drug industry will do anything – including withholding information about the dangers of their drugs – in the name of keeping their products on the market.  The Pharmaceutical Research and Manufacturers Accountability (PhRMA) Act will help put an end to these dangerous corporate tactics by holding executives criminally liable when their misdeeds lead to serious adverse drug experiences.

The PhRMA Act also forces drug companies to meet FDA requirements for post-approval studies.  Currently, under the fast track process at FDA, drugs are often approved with the caveat that manufacturers complete specified post-marketing studies of safety and effectiveness. Drug manufacturers often fail to complete these studies because the FDA doesn’t have sufficient enforcement tools.

SUMMARY

The bill takes three distinct steps to ensure both the government and consumers have access to important information they need to make decisions on the safety of prescription drugs.

1) The proposal would send drug industry CEO’s and other executives to jail for a minimum of 20 years if they knowingly conceal serious adverse drug experiences. A fine of up to $2 million could also be imposed on an individual found to be in violation.

2) Drug companies CEO’s would be required by the bill to annually attest that all evidence of serious adverse drug experiences for an approved drug has been disclosed to the Secretary. Failure to attest would result in fines of up to $100,000 per month for individuals and $1 million per month for the corporation. The Secretary would also have the option to remove a drug’s approval under this situation.

3) The PhRMA Act requires post-marketing studies to be completed in a time-period specified by the by the Secretary.  Failure to complete these studies would lead to fines of up to $5 million for each month the study goes unfinished.  FDA would retain the authority to pull a drug from the market if manufacturers fail to comply.

The Pharmaceutical Research and Manufacturers Accountability Act will help keep the prescription drug market safe from profit driven manufacturers who care more about stockholders’ earnings than patients’ health.  For more information on this legislation or to become a co-sponsor please contact Chad Shearer at 5-5065 or chad.shearer@stark.house.gov.