For violators of FDA rules in general, injunctions, arrests and fines are on the rise.

WASHINGTON (AP) – The government is ordering the maker of a popular anti-cholesterol drug to air corrections after overstating Pravachol’s benefits in ads to both consumers and doctors – an unusually tough move that signals more scrutiny of how truthful drug companies are about their products.

The Food and Drug Administration’s new commissioner highlighted the order to Pravachol maker Bristol-Myers Squibb Co. in a speech Friday designed to put the industry on notice that the agency is getting tougher with lawbreakers.

Bristol-Myers received a warning letter from the FDA about the Pravachol ads on Thursday, company spokeswoman Julie Keenan said Friday.

“Bristol-Myers Squibb will work closely with the FDA to resolve all issues outlined in the letter,” Keenan said.

For violators of FDA rules in general, injunctions, arrests and fines are on the rise, said FDA Commissioner Mark McClellan.

But among the priorities McClellan singled out Friday is increased scrutiny of what makers of drugs, dietary supplements and other products tell consumers and doctors about those products’ benefits.

“I consider it a public health hazard when people are misled by false claims,” he said.

As part of that increased scrutiny, manufacturers should expect new guidelines soon on how to ensure direct-to-consumer advertising of prescription drugs is truthful, he said.

“I don’t want to just play whack-a-mole with ads,” McClellan told reporters, promising the guidelines would help deter misleading ads in the first place.

Direct-to-consumer drug advertising has tripled, to $2.8 billion worth a year, since the FDA loosened restrictions in 1997. Drug makers argue the ads inform people about the latest treatments. Critics argue the ads too often make pills seem a panacea, and the most expensive drugs are advertised while cheaper, unadvertised ones might work better. The FDA will hold a special conference next month to hear both sides before issuing the new guidelines.

The FDA’s new scrutiny won’t be just on ads, McClellan warned. Manufacturers spend almost twice that amount on sales visits to doctors to promote their products, and another $2 billion on “educational events.” The FDA is working with the Securities and Exchange Commission to investigate misleading promotion and even criminal kickbacks, and will have “more to say soon,” McClellan promised.

“Shady claims” by the largely unregulated dietary supplement industry also are going to get more FDA scrutiny, he said.

Underscoring McClellan’s warning about over-enthusiastic salesmen, the FDA on Friday ordered another company, Gilead Sciences, to quit downplaying the risks of its anti-HIV drug Viread at AIDS meetings – and to tell salesmen to quit calling it a “miracle drug.”

The letter marked the FDA’s second warning about the drug’s promotion, and to Gilead. FDA ordered the manufacturer to get accurate information about the drug’s risks and benefits to doctors who attended the meetings in question.

Gilead said it took the warning seriously and would retrain sales staff not to over-promote products, said spokeswoman Amy Flood.

For Pravachol, one of the top-selling anti-cholesterol medicines, the FDA complained that ads in major newspapers and magazines give consumers the impression that the drug is the lone treatment for preventing strokes. It’s not, and it only reduces the risk of strokes in people who already have heart disease, the FDA said.

Bristol-Myers must cease the ads at once and air corrections, the FDA ordered – an expensive endeavor that is an unusual remedy for the agency.