Testimony Urges Senators to Strengthen Drug Safety Reform

Consumers Union is urging the Senate health committee to strengthen several measures in a bipartisan drug safety bill -- including quicker publication of clinical trial results and tougher penalties for drug companies that fail to perform safety studies -- to help prevent future Vioxx-type disasters.

"Too many Americans have died or been injured because pharmaceutical companies suppressed clinical trials and other studies with critical safety information," says Jim Guest, president and CEO of Consumers Union, publisher of Consumer Reports, who is testifying at today's hearing.

"We support the bill's clinical trial registry requirements, but urge that publication of results be required within one year, not two," says Guest, adding that all Phase II trials results also should be made public, as well as studies conducted prior to the legislation.

Guest was scheduled to testify before the Senate HELP Committee on S. 3807, the Enhancing Drug Safe and Innovation Act of 2006, a bipartisan bill introduced by Sens. Mike Enzi (R-Wyo.) and Ted Kennedy (D-Mass.).

To read Guest's complete testimony submitted to the Senate HELP committee, go to http://www.ConsumersUnion.org

Consumers Union supports the bill as a good first step toward reforming the nation's broken drug safety system, but is urging it be strengthened to ensure the Food and Drug Administration can adequately protect the public on drug safety issues.

"This bill is a good first step, and it will bring greater balance to the process, save countless lives and help restore the public trust in our nation's drug safety system," Guest says. "Despite what the pharmaceutical industry would have the public believe, this bill does not impede rapid approval of safe, effective medications, particularly life-saving drugs."

In addition to the clinical trial improvements, Consumers Union is urging the Senate committee to strengthen the bill in several key areas:

-- Improve the FDA's power to protect the public health by reviewing drugs for safety problems once they have been on the market for five years, and again on a 10- to 15-year basis. Most drug adverse events do not show up until nearly seven years after a drug has been approved.

-- Limit advertising for new drugs for up to three years, not just two.

-- Increase civil monetary penalties, especially for repeat offenders who do not perform required safety studies.

-- Require safety studies of those drugs most widely used off- label.

-- Require that at least 90 percent of Advisory Committee members who ultimately decide whether a drug should be approved for market are free of conflicts-of-interest from the drug industry

-- Establish a climate of open and honest scientific debate at the FDA by institutionalizing a system of transparency, making public all staff dissent and additional views on new drug applications, and ensure whistleblower protections

-- Ensure more resources so the agency can do its job. One option is to free the FDA from detailed restrictions on how user fees are spent, or to increase user fees to deal with the backlog of safety issues.