Edwards: Ban DTC For New Drugs For 2 Years
5 CommentsBy Ed Silverman // October 28th, 2007 // 5:25 pm
The Democratic contender raises an issue that was, initially, addressed in the recently passed FDA Amendsment Act, otherwise known as FDA reform, but was eventually watered down. You may recall the toughest restrictions in early drafts of the bill gave the FDA authority to block a drugmaker from advertising a med that carried serious safety concerns. But that was omitted. Instead, the FDA will get new power to require drugmakers to submit TV ads for review before they run, but can only recommend changes, not require them. The bill lets the agency levy fines for false and misleading ads.
Edwards believes this isn’t enough. And so he’s outlined a plan to regulate what he views as misleading drug ads, the Associated Press reports. And to bolster this conviction, Edwards argues that annual spending on such ads nearly has quadrupled to $4 billion in the decade since the government relaxed rules on advertising directly to consumers. He adds that spending on marketing and administrative expenses was twice as much as R&D.
“You’ve seen these ads. You know who’s paying for them, right? You are,” Edwards told a town hall meeting at a New Hampshire high school. “You’ll be skipping through the fields holding hands with your spouse. Basically, they do what they want, and they’re driving up demand for the most expensive and most profitable drugs. The next president needs to deal with this issue.”
The two-year delay would prevent TV ads from driving consumers to drugs that haven’t been proven safe, and would require drugmakers to get FDA approval before launching major ad campaigns. “I think two years makes sense. I think it gives enough time for a drug not just to have been tested in clinical trials but to be out among the public, to see what kind of adverse reactions there have been,” he told reporters later.
His plan also includes increased penalties for drugmakers that violate truth-in-advertising laws and would require disclosing more info about side effects and effectiveness compared to placebos and less expensive alternative drugs. Doing so would ensure that “salesmanship is not trumping the facts, so people learn what the real risks are associated with these drugs,” Edwards insists. And at several campaign stops, he told voters they can start ending the corrupting influence of drug company lobbyists and other special interests even before the election.
“If you, New Hampshire primary voters, said starting today, ‘I will not vote for a candidate for president who takes millions of dollars from Washington lobbyists, period, it would stop. I’m telling you, it would stop,” he said at a Concord middle school. “This is not about punishing anyone. This is about making the system work.”
Edwards has tried to portray Sen. Hillary Rodham Clinton as beholden to Washington lobbyists because, unlike him, she accepts their money. He said that in his days as a trial lawyer, he would have been charged with bribery had he offered money to the jurors he was trying to convince. “In Washington, when they do it, it’s called politics,” he said.
But why didn’t the FDA reform bill contain tougher advertising restrictions? Intense lobbying by advertising agencies and broadcasters, as well as drugmakers, of course. Various lobbying groups, including the National Association of Broadcasters, the Advertising Coalition and drugmakers, argued the initial legislation created First Amendment issues.
The FDA, by the way, last week published a notice in the Federal Register explaining the new DTC user fee program, asking drugmakers to notify the agency within 30 days whether they intend to participate in the program, and identify the number of planned DTC TV ads in the next fiscal year.
CA
Agreed! The DTC effort should be prohibited as it is in Europe. Instead of billions spent on inappropriate marketing efforts, Big Pharma should lower their prices for people that can’t afford it!!!!
Atlex
What makes it inappropriate, the fact that you don’t like it? Ever hear of the US Constitution–say the First Amendment. Pharma companies have the same rights as you do with regards to free speech and advertising typically falls under that protection. Can the government put restrictions on advertising–perhaps a few, but with limits?
Finally, your last statement makes no sense when you look at the data. The industry spent between $3 and $4 billion dollars last year on DTC. This amount to 1% to 2% of sales. Even if all of these expenses were directed toward lowering prices, the drop would be miniscule. Many would argue that a ban on advertising would yield increased prices.
Jack
There is one updside to DTC advertising - it increases awareness of treatment options. I don’t have restless leg syndrome, but if I did, would I know someone made a drug to treat it without DTC advertising? Probably not.
Alexander Hamilton
Good grief. The American Constitution functioned very well without DTC ads of the sort we have now. Even Bill Frist once supported a 2-year moratorium. Is he also an enemy of liberty and all things Constitutional?
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