'The Vioxx example showed that the FDA and Merck were too close for comfort. Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by [Vioxx manufacturer] Merck.'

"An independent drug safety office would more effectively regulate drugs once they're on the market," Sen. Grassley maintained. "If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drugs on the market in the first place."

The prospective legislation would provide that the drug safety office would have an independent director, along with the regulatory authority to require label changes, he said.

Accutane and Depression

Calling whistleblowers "patriots" who risk their own careers in the interest of public safety, Sen. Grassley recounted the recent controversies over the acne drug Accutane and the arthritis drug Vioxx that were fueled in great part by the efforts of two FDA scientists to shed light on their potential risks.

In the case of Accutane, which has been linked to depression and suicide risk, the FDA canceled an advisory committee presentation by Dr. Andrew Mosholder, the agency's in-house expert in the area, to avoid "confusing" the committee with different views. Dr. Mosholder found that there was a link between Accutane and depression, but FDA management disagreed.

"Instead of allowing Dr. Mosholder to present his findings publicly and subject them to committee scrutiny, the scientific process and his peers, the FDA effectively muzzled him," said Sen. Grassley. "But despite the FDA's best efforts, Dr. Mosholder wouldn't be silenced. Ultimately, months later, Dr. Mosholder was proven right."

Vioxx and Heart Disease

Sen. Grassley also recalled the more explosive Vioxx controversy, which was propelled by another FDA scientist, Dr. David Graham. The FDA "disregarded and stonewalled" concerns raised by Dr. Graham, Sen. Grassley charged.

"Dr. Graham completed a study that found an increased risk of heart attacks and strokes in patients taking Vioxx," Sen. Grassley told the Consumer Federation. "His immediate supervisor, however, dismissed this study as 'scientific rumor.' The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx, the FDA approved the use of Vioxx for children," he noted.

"The director of FDA's office of new drugs suggested that Dr. Graham water down his Vioxx conclusions. Dr. Graham replied that in good conscience he could not. When Dr. Graham was asked to present his findings at my committee's Vioxx hearing, he was also undermined. News reports that day show that Acting FDA Commissioner Dr. Lester Crawford called Dr. Graham 'a maverick who did not follow agency protocols.'

"This statement -- made on the eve of the hearing -- could logically serve no purpose other than to intimidate Dr. Graham," said Sen. Grassley.

'Too Close for Comfort'

"The Vioxx example showed that the FDA and Merck were too close for comfort," he said. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by [Vioxx manufacturer] Merck."

Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen. Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.

In the end, the scientific process prevailed, and today there is a black-box warning label on Vioxx -- which carries the FDA's strongest cautionary advice to physicians, noted Sen. Grassley. The case pointed out the "enormous implications of getting drug safety right or wrong," he said, as 20 million Americans were taking Vioxx.

"The job for Congress, the FDA, and consumer advocates is to get to the bottom of drug safety procedures and figure out, once and for all, what it'll take to make sure Americans can trust what's in our medicine cabinets," said Sen. Grassley.

The FDA "needs to demonstrate that it is unequivocally committed to the scientific process -- and those who speak up on its behalf -- when it comes to drug safety and that nothing gets in the way of that, whether it s pressure from profit-oriented drug makers or institutional ego that doesn't want to admit a mistake," he urged.

Good Works Tarnished by Greed

Acknowledging that the FDA has done "decades of good work," and that the pharmaceutical industry has developed "miracle drugs that heal and cure," Sen. Grassley noted that drug companies profit immensely from their efforts and that the huge profit incentive sometimes leads to fraud.

"According to the Department of Justice, there are currently under seal in the neighborhood of 100 whistleblower cases involving allegations against over 200 drug companies. During the past four years, the department recovered nearly 2 and a half billion dollars from whistleblower cases against drug companies," Sen. Grassely pointed out.

"In this fraudulent environment, the FDA's mission is more important than ever before. The FDA absolutely has to do a top-notch job on ensuring drug safety," he emphasized.

"When the FDA approves a drug, it should be a Good Housekeeping seal of approval. Americans should be able to bank on the benefits outweighing the risks. Consumers shouldn't have to second-guess the safety of what's in their medicine cabinets," Sen. Grassley said.