 last week that Vytorin did not show any evidence of reducing fatty plaque buildup in veins and arteries stirred up a lot of complaints from industry pundits who felt that the public was misled by pharma.

There's only one hitch: The two pharma companies never stated that the drug, a cholesterol-lowering combination of Zocor and Zetia, had an effect on plaque.

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News Analysis

Unlike Vioxx, Vytorin works exactly as explained in its now-famous food-and-family ads. So why are people up in arms against the drug? Experts ponder what went wrong.

Vytorin Study Causes Media Stir, but Are the Concerns Justified?

 on its Division of Drug Marketing, Advertising, and Communications (DDMAC) Web site last week stating that the direct-to-consumer television advertisement user fee program was being canceled due to lack of appropriate funds.

When President Bush signed the Prescription Drug User Fee Act in September last year, he included a provision that if FDA failed to raise at least $11.2 million in review fees by January 25, 2008, the program would be null and void.

Additionally, Congress sealed the program's fate on December 26 by declining funding for the user fee program and instead giving $4 million to fund traditional DTC prereviews.

"[FDA] held a party and nobody came," said Lou Morris, former acting director of DDMAC. "They didn?t make their $11 million nut, so they decided they couldn't forward fund it. Therefore, they basically scrapped it—at least temporarily."

This comes less than one month after FDA announced that pharma companies seeking to have their ads reviewed would need to shell out over $40,000 per television spot. In addition, a $165,000 one-time operating reserve fee would have to be paid to get in the front door.

Reactions to the program have been mixed from the get-go. Some industry experts felt that the ads would put pressure on pharma to create better advertising, while others felt that the pay-to-play program could lead to situations where pharma companies refuse to take blame for misleading commercials that get approval.

Some also wondered why the program wasn't set up like traditional user fee plans, where the government prefunds the program and then recoups the funds once the details have been ironed out.

"It's hard to presell something like this," Morris said. Agencies don't want to pay for it until they know how often they are going to use it. People just don?t plan to that level of detail."

Update: The Associated Press announced late Tuesday that Merck/Schering-Plough have voluntarily pulled all consumer television advertising for Vytorin and Zetia, citing "mischaracterization and misinterpretation of the enhanced trial results." No word on how long the ads will remain off the air.

In a surprising but not completely unexpected move, FDA announced last week that its Prescription Drug User Fee Act was dead on arrival. Feds cite lack of funding as main reason.

FDA Puts Kibosh on DTC User Fee Program

Yesterday, Verispan released the results of its biannual Managed Care Pharmacy Executive Audit, and Novartis is once again in the driver?s seat--holding the top position for the 11th consecutive time.

The audit is a panel-based survey answered by pharmacy directors at managed care organizations who are directly involved in formulary decisions.

Pharmacy executives regularly meet with pharma account directors to discuss decisions about drugs and new advances in therapeutic categories. The directors also provide unbiased education seminars for members of the plan or physicians affiliated with a plan. "It's not just about products. It is also information for the betterment of the physicians or the members themselves," said Keith Mandia, senior director of managed care product management at Verispan.

To conduct the study, Verispan used a list of executives who are in the pharmacy arena within the managed care companies. The only criterion was that they must have interactions with the account directors and be involved in pharmacy-related decisions. "Naturally, it's in our best interest to have folks on the panel that are common accounts of interest to our clients, but they can be small, medium, or large managed care organizations," Mandia told 

From cycle to cycle, Verispan retains approximately 85 percent of its panel. The executives rank account personnel, contracting, value-added programs, and an overall corporate approach. Finally, though not included in the overall ranking, is how helpful pharma companies are in regards to Medicare Part D.

"These companies that are in the top five are longtime participants in partnering with managed care organizations," Mandia said. 'These are the ones that we would typically see the top five or top ten for sure."

Managed care pharmacy executives list their favorite pharmaceutical companies based on promotional activities and the ability to meet managed care needs. Novartis reigns for 11th straight quarter.

Pharmaceutical Executive-01-23-2008

Vytorin Study Causes Media Stir, but Are the Concerns Justified?

FDA Puts Kibosh on DTC User Fee Program

Novartis Takes Top Spot in Managed Care Audit--Again