“This repeal effort was started by legislators concerned that the law is hurting the state’s economy,” explained PhRMA’s Senior Assistant General Counsel Marjorie Powell in a prepared statement. “And it is certainly true that it adds an extra level of administrative complexity for companies in the state. Pharmaceutical marketing is already effectively regulated by such federal government agencies as the Food and Drug Administration.”

The Massachusetts ban was part of the larger Health Care Cost and Quality Act. Although the bill is best known for extending health insurance almost universally in the state, it also created a new code of conduct for sales reps and established penalties for wayward reps of up to $5,000 per violation. It also created the Massachusetts Public Health Council, which has the power to create rules further limiting marketing practices.

Last year the Council passed new rules for both pharma and medical device companies, making Massachusetts the state with the most comprehensive marketing and disclosure code. The rules specifically mandate disclosure of fees, payments and other compensation to doctors; ban promotional items such as pens and mugs; and restrict meals to those provided at training or educational events. Payments for research and clinical trials, rebates and discounts, prescription drugs provided for patient use and demonstration units for charity care are exempt. All other payments of $50 or more must be disclosed.

Currently, Vermont and Maine have bans on all food service “gifts” to physicians. Minnesota limits gifts to under $50, while California, Louisiana, Maine, Massachusetts, West Virginia and the District of Columbia all require pharmaceutical and biotech companies to report marketing spending on physicians, but do not ban food service outright.

The popularity of unbranded pharma Web sites amongst consumers appears to be on an up tick, according to new data released by Manhattan Research this week.

The report, “Unbranded Web sites: Brand Reach throughout the Patient Life Cycle” looked at how many consumers actively use unbranded pharma sites and to what degree they trust the information. Thirty-five percent of consumers interviewed said that they do use these sites though many might not have been aware that pharma companies ran them.

“We found that relatively few consumers outright mistrust pharma online resources,” said Monique Levy, senior director of research, Manhattan Research. “On the flip side, there a lot of consumers that are cautious yet open to using pharma resources.”

When asked what kind of content they would like to see on the site, information about the condition wasn’t the primary service or utility that they were looking for. The top tools consumers want are financial assistance and incentives, tools for finding specialists, and tools that allow them to manage their condition day to day.

“People are not looking for the type of information that they can find on a WebMD, disease association, or a government site,” Levy said. “They seem to be interested in looking for supportive services.”

Levy said that marketers commonly state that it’s hard to measure the impact of unbranded initiatives. The goal of informational campaigns is to raise awareness and motivate consumers to find out more about the category and the disease, thereby raising sales of prescription drugs.

“After visiting an unbranded site, a significant share of consumers research more information about the condition itself as well as treatments for the condition,” Levy said. “That’s a positive indicator that these initiatives are working.”

After months of increasingly rancorous debate, the House finally approved legislation March 21 that makes significant changes in the nation’s health care system. The Senate is slated to approve the House-passed changes to its original reform bill shortly.

Of most importance to pharmaceutical companies, the legislation promises to significantly expand the number of Americans with some kind of health care coverage. This will enlarge the market for prescription drugs and moderate pressures for price controls. The legislation sets up a scheme to eliminate the confusing and contentious “doughnut hole” in the Medicare program, while avoiding proposals for government negotiation of Medicare drug prices. Drug reimportation is off the table, at least for the moment.

A major plus for pharma is that the bill establishes a clear pathway for authorizing follow-on biologics. Brand-name firms won a 12-year data exclusivity period, despite loud protests from generics makers. But all manufacturers are likely to benefit from clearer policies on how to proceed in developing and regulating “biosimilars” and “biobetters.”

Pharmaceutical companies will finance the high cost of reform by paying additional fees and higher Medicaid rebates. Fees based on a company’s share of market are slated to total $28 billion over ten years, starting at $2.5 billion in 2011. The Medicaid rebate also increases from 15 percent to 23 percent.

The legislation reshapes the health insurance market as well as government health care programs, all promising to impact the coverage and delivery of prescription drugs. Implementation will be a huge challenge, especially for state governments. Republicans, as well as various interest groups, are already looking for revisions and challenges. We will examine these issues more fully in the next issue of Pharm Exec.

A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity.

The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They made it clear, however, that they are not calling for a ban on acetaminophen alone, or banning the narcotic component of the pain drugs—just those factors in tandem.

“The top recommendation of the committee is that the agency needs to do something to address and decrease the ‘usual dose’ of acetaminophen for OTC products and prescription combination products,” said Sharon Hertz, deputy director, Division of Anesthesia, Analgesia, and Rheumatology Products, CDER. “The usual dose that people take, whether it’s called the single dose or the maximum daily dose, should be lowered to ensure a greater margin of safety.”

With regard to prescription products, FDA said that there is a high likelihood of overdose of prescription narcotic acetaminophen products, and if those products are not eliminated the acetaminophen dose should be lowered significantly. The panel also suggested boxed warnings so that physicians will be more aware of the potential for liver damage.

“This is clearly an issue that’s been on FDA’s mind for a long time,” said Gerald Dal Pan, director, Office of Surveillance and Epidemiology, CDER. “In 2007, we looked at the results of an education campaign, and formed an internal group at CDER to examine the issue and report some recommendations. This is the result of those recommendations.”

FDA said that there is no silver bullet to reverse the trend, and that label changes and public awareness campaigns wouldn’t have solved the problem.

No Surprise

“This is not a problem that arose overnight,” Hertz said. “The problem is very complicated and has multiple components. There probably isn’t one thing that will reverse the trend of acetaminophen-related liver toxicity. In addition, all of the components of the problem are moving at the same time that use patterns are changing. New products are coming and going from the market, and different patterns of prescribing are occurring.”

OTC combination drugs such as NyQyil are not in question, Nelson said, because data showed indicated many deaths each year from prescription combination products, and deaths from OTC treatments are far lower.

“Based on that epidemiology, you get more bang for the buck by eliminating prescription drugs,” Nelson said.

FDA is now going to back and look at the discussion and decide whether they want to move on the advisory panel’s suggestion. Pharma companies are being encouraged to change their labels and address dosage quantities before FDA announces any changes.