Lawmakers plan to curb TV prescription drug ads

From The New York Times:

In the 1980s, Nancy Reagan told Americans to “Just Say No” to recreational drugs.

Now a handful of legislators are just saying no to TV commercials for prescription drugs. The politicians are taking aim at the 60-second spots that have made viewers familiar with maladies like male urinary urgency and deficient eyelashes (pictured)— not to mention side effects like four-hour erections.

Representative James P. Moran, Democrat of Virginia, is sponsoring a House bill that would ban ads for prescription sexual aids like Viagra and Levitra from prime-time television, on decency grounds. Representative Henry A. Waxman, Democrat of California, has said he favors empowering the Food and Drug Administration to bar consumer advertisements for new drugs for an initial period after the F.D.A. approves them — until there has been more real-world experience with the medications.

Meanwhile, Representative Jerrold Nadler, Democrat of New York, has introduced a bill called the Say No to Drug Ads Act. It would amend the federal tax code to prevent pharmaceutical companies from deducting the cost of direct-to-consumer drug advertisements as a business expense.

“You should not be going to a doctor saying, ‘I have restless leg syndrome’ — whatever the hell that is — or going to a doctor saying, ‘I have the mumps,’ ” Mr. Nadler said in an interview. “You should not be diagnosed by some pitchman on TV who doesn’t know you whatsoever.”

In the context of the battle over health care reform in Washington, the war on drug ads may represent but a side skirmish. Over the years, legislators have introduced and failed to enact similar bills to restrict drug advertising.

Such measures never get very far because they conflict with free-speech rights, said Billy Tauzin, the president of the Pharmaceutical Researchers and Manufacturers of America, an industry trade group.

Representative Charles B. Rangel, Democrat of New York and chairman of the House Ways and Means Committee, said last month that legislators would consider ending the tax break for drug ads as a way to raise money to pay for the health care overhaul. But, after lobbying from broadcasters and newspapers, Mr. Tauzin said, legislators quickly abandoned the idea, concluding that such a measure would not raise significant money.

With lawmakers still fighting over how to finance health care reform, Mr. Nadler said he hoped his bill might find an audience.

“On First Amendment grounds, I am not going to say we will ban” drug advertising, said Mr. Nadler, who represents parts of Manhattan and Brooklyn. “But they should not be able to get taxpayers to subsidize it.”

Meanwhile, Representative Daniel Lipinski, Democrat of Illinois, is pushing his own bill that would end the tax deduction for drug company spending on advertisements.

For some legislators and consumer advocates, the ads are a daily reminder of a health care system run amok. Critics contend that drug ads are intended to prompt people to diagnose themselves with chronic quality-of-life problems like insomnia or restless leg syndrome; lead people to pressure their doctors for prescriptions for expensive brand-name drugs to treat these conditions; and steer people away from cheaper generic pills.

And, critics say, such ads may overstate benefits and understate risks of drugs, or by drumming up audiences for the latest pills at a time when the side effects of such drugs may not yet be fully known.

Some academic studies have indicated that such advertising can help people who do need treatment to start taking, and stay on, appropriate drugs, said Julie M. Donohue, an assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health.

In 2008, pharmaceutical manufacturers spent about $4.8 billion on direct-to-consumer television, radio, magazine and newspaper advertising, according to Nielsen Media Research. But that sum represents merely a “rounding error” in the estimated national health care bill of $2.4 trillion, Robert Ehrlich, a pharmaceutical marketing executive, wrote earlier this month on his blog.

“It is easy to criticize, even though they know the money is trivial compared to overall health spending,” Mr. Ehrlich said in an interview. “When every congressman can see it on the 6 o’clock news, it just reinforces the problem.”

He added that drug companies spent much more on direct marketing to physicians.

Ads, however, do drive up the number of prescriptions and increase drug revenue. Of the $235 billion spent last year on prescription drugs in the United States, an estimated $8 billion could be a result of drug ads, Mr. Ehrlich wrote in his blog.

The United States is one of only two countries that permit direct-to-consumer drug advertisements. The other is New Zealand, where several years ago some health officials and politicians tried and failed to ban drug ads.

In this country, drug ads must list known side effects. And under current regulations, drug makers voluntarily submit ads to the F.D.A. for vetting before they appear. In May, the agency published new guidelines cautioning companies not to play down a drug’s risks by using tricks like distracting viewers with loud music or using a typeface smaller than the one used to describe a drug’s benefits.

Some legislators and consumer advocates cite past episodes that they say demonstrate the need for tighter regulation of drug advertising.

In 2004, for example, Merck withdrew the pain drug Vioxx from the market over safety concerns, after years of robust sales that were stoked by extensive consumer advertising.

In 2008, Pfizer stopped running a television commercial for its blockbuster cholesterol drug Lipitor after critics charged the ad misrepresented the credentials of a doctor who endorsed the drug.

In February, attorneys general from 27 states ordered Bayer Pharmaceuticals to run a $20 million campaign to correct deceptive ads for Yaz, a popular birth control pill.

And last week, under a settlement with attorneys general from 35 states who charged that Merck and Schering-Plough had overstated the benefits of the cholesterol drug Vytorin, Merck agreed to submit all new television commercials to the F.D.A. for approval before they are broadcast.

Because health problems with new pills sometimes emerge several years after the drugs go on the market, critics react more strongly to drug ads than to ads for products like cars or alcohol whose risks are known, said Prasad Naik, a professor of management at the University of California, Davis.

“Five years later, they say it causes blindness, and now you’re in trouble,” said Mr. Naik, who has conducted research on pharmaceutical marketing. So it makes sense, he said, that “legislators are sensitive to it and say, ‘Don’t make it so easy to sell.’ ”