CALPIRG and U.S. PIRG, the Federation of State PIRGs, Support the Enhancing Drug Safety and Innovation Act of 2007

U.S. PIRG—a nonpartisan, nonprofit public interest organization—supports H.R.1561, the “Enhancing Drugs Safety and Innovation Act of 2007”, which includes much-needed prescription drug safety sections.

The bill will improve the Food and Drug Administration’s ability to protect consumers.  It will reduce the number of patients who suffer adverse effects from prescription drugs, and it will save lives.
H.R. 1561 will:

1.    Strengthen Enforcement Powers at the FDA. Currently, the FDA lacks the authority to impose meaningful fines or sanctions when drug companies fail to do post-market studies or conduct misleading advertising campaigns. H.R. 1561 gives FDA the power to impose civil monetary fines of up to 10% of a drug’s gross U.S. sales revenue (capped at $1 million). It gives the FDA broader enforcement powers such as requiring special symbol on drug packages for the first two years the drug is on the market, and restricting the use and distribution of some drugs.

2.    Shine the Light on Clinical Studies.  Some drug companies highlight studies that show the benefits of their drug and bury studies that show their drug to be ineffective or unsafe.  GlaxoSmithKline’s Avandia, a diabetes drug linked to a significant increase in the risk of heart attacks, appears to be the latest example. H.R. 1516 requires that all phase II though IV clinical trial be made available in a publicly accessible registry and results database. Studies must be made public so that doctors, researchers and the public have access to needed information. Doctors, researchers and the public must also have access to FDA reviews of these studies.

3.    Increase Resources to Monitor Drug Safety.  The vast majority—as much as 90%—of FDA’s resources for drug evaluation and research are spent approving new drugs. H.R. 1561 permits PDUFA funds to be used for past-market drug safety.  U.S. PIRG recommends that 25% of PDUFA fees go toward post-market drug safety.  Additionally, the FDA must have increased resources to review ads before they are viewed by the public.

4.    Place Restrictions on Marketing New Drugs.  Studies conducted on a drug prior to approval are not broad enough to always find harmful side effects. For this reason, direct-to-consumer advertisements on television and in print should be restricted.  H.R. 1561 may impose a three year moratorium on some direct-to-consumer advertisements. This will create a window of time during which the FDA can monitor real-world use of new drugs before advertising campaigns expand a drug’s use to markets far greater, less healthy and more diverse than those studied in clinical trials.

U.S PIRG supports friendly amendments to H.R. 1561 that strengthen drug safety language in the bill such as enhancing the conflict-of-interest rules for advisory committees. The FDA relies on outside experts to guide its decisions on a range of critical issues.  Scientists on a company’s payroll or receiving stock or other compensation cannot be objective parties. The FDA must stop appointing advisory committee members whose conflicts of interest create biases. For instance, nearly one-third of the advisers who voted to approve Vioxx had taken money from the drug’s manufacturer.

For more information, contact Paul Brown, US PIRG Consumer Health Care Advocate, (202) 546-9707 ext 304 or pbrown@pirg.org