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Tess Vigeland: Every five years, Congress passes the hat to drug companies in the form of what’s called the Prescription Drug User Fee. It’s not actually a fee on users or prescription drugs, it’s a fee on Big Pharma. The money goes to the Food and Drug Administration, and is used to help run the drug-approval process.
The fee is scheduled to expire on September 30. The Senate already reauthorized it, the House will vote on the bill after its July 4 recess. If it passes, drug companies will have to pay a lot more into the pot — as much as $225 million over five years.
But not everyone thinks the extra money will make drugs safer. From Washington, Snigdha Prakash has the second of two reports.
Snigdha Prakash: Blame it on Vioxx, the blockbuster painkiller whose cardiac side-effects led to its withdrawal in 2004 after 20 million Americans had used it. Despite the drug industry’s strenuous lobbying, most lawmakers have come to believe that American drugs aren’t as safe as they should be.
California Democrat Henry Waxman has taken the lead in the House on figuring out why.
Henry Waxman: There’s a real push to get drugs approved as quickly as possible. And because of that rush to get drugs approved, we sometimes don’t know until larger numbers of people are using the drug that there’s a safety problem.
Waxman says drugs need to be scrutinized more closely after they’re on the market. But he says the FDA isn’t set up for that.
Waxman: FDA lacks the resources to do reviews that need to be done to catch safety problems. They need personnel to monitor these drugs. They need to make sure that the companies are doing the post-approval studies for safety.
The House Energy and Commerce Committee voted late last month to give the FDA those resources by imposing higher user fees on drug companies. It also voted to give the FDA new authority to demand that companies tell patients about safety risks they find.
But some inside the FDA don’t think drugs will be any safer as a result.
David Graham is deputy director of the FDA’s office of Surveillance and Epidemiology and an outspoken critic of the FDA’s safety record. Because the FDA won’t let Graham meet with reporters at his office, we went to a deli near his house outside Washington, and Graham explained why he’s skeptical:
Graham: The drug safety problems that we’ve had in the recent past, and even in the more distant past, have not been failures of surveillance or failures of identifying the safety problem. They’ve been failures of decision-making. Throwing money at the FDA won’t change the way decisions are made.
Graham says the problem is the same FDA team that approves a drug for sale also decides what to do if safety problems emerge later. He says approval teams don’t like to issue strong safety warnings or to pull drugs. Such actions raise questions about their initial judgments, and they also make drug companies angry.
Iowa Republican Chuck Grassley agrees with Graham. As chairman of the Senate Finance Committee for many years, Grassley investigated the FDA’s handling of drug-safety issues. He describes how the FDA treated scientists with safety concerns in a recent case:
Charles Grassley: There was a great deal of intimidation not to detract from the party line. And the party line is, “Don’t raise questions.”
In May, Grassley tried — and failed by just one vote in the Senate — to change that culture some. He offered an amendment to the Senate’s user fee reauthorization bill to give the FDA’s “Office of Surveillance and Epidemiology,” which tracks drugs after they go on the market, power to ACT if it sees problems. Right now, that office can only advise the folks who approve the drug.
The drug industry opposed the change. It says the right way to make such decisions is by scientific consensus. The FDA also opposed it.
An FDA spokeswoman turned down our request for an interview. But at a recent congressional hearing, FDA commissioner Andrew von Eschenbach made his feelings clear. He was flanked by the head of the drug approval office and the head of the surveillance office as he spoke:
Von Eschenbach: We’re here as partners, dedicated to collaborating even more closely to do the right thing.
California Democrat Henry Waxman says Americans are counting on the FDA to do just that — by acting promptly on safety problems once it has new powers and money.
In Washington, I’m Snigdha Prakash for Marketplace.