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Board of Pharmacy unpacking 1993 health reform law

 

23-Mar-2007: That is how many are describing Minnesota's law requiring pharmaceutical and medical device companies to annually disclose all financial dealings with doctors and other people who prescribe drugs.

In 1993, the Minnesota Legislature passed a sweeping health reform bill. Included in it was the first law in the nation requiring drug company disclosure.

For years, no one looked at the forms stored in boxes at the Minnesota's Board of Pharmacy. That has changed.

This week a report compiled by doctors and a national watchdog group called Public Citizen was published in the Journal of the American Medical Association. Besides turning the spotlight on drug companies and doctors, the report brought the disclosure process to light.

"Although these laws are well-intentioned, they are so riddled with loopholes in drafting and enforcement that they are not delivering what they are supposed to," said Peter Lurie, deputy director of Public Citizen.

A former Rochester lawmaker who helped draft the bill, Sen. Shelia Kiscaden, said, "The Board of Pharmacy fell down on this, and the Legislature fell down in not saying what has been learned from this."

Kiscaden described the disclosures as a chance to look into what might be a reason for increasing health care costs.

Many health care costs are driven by the consumption of drugs and medical devices, which is higher in the United States than anywhere else. And companies' marketing contributes to the costs.

"We need to know what they are doing in that marketing," Kiscaden said. "Our intention was to make sure all of that was transparent, so you didn't have undue influence."

With no one looking at the disclosures, the transparency hasn't really occurred in the years since the rule was put in place.

"It was somebody's good intention," said Cody Wiberg, executive director of the Board of Pharmacy.

This is a good intention that Wiberg inherited when he took the job about 18 months ago.

As the organization that licenses pharmacists and inspects pharmacies, drug company disclosure forms were not on his radar when he started the job. However, soon a simple question changed that.

He was asked if a drug sales representative buying a meal for a doctor is considered a gift? Under the rules passed in 1993, pharmaceutical companies are restricted from giving gifts worth more than $50.

"In this process of trying to answer this, I started to review the disclosures," he said. "I realized some of the data looked to not be complete."

Wiberg eventually wrote a Frequently Asked Questions document about the disclosure issues and posted it on the board's Web site. In it he ruled that meals are gifts.

However, the FAQ says, "A meal is not considered a gift if the practitioner is serving on the faculty at a professional educational conference or meeting, or if the practitioner is providing to the manufacturer 'substantial professional and consulting services' as part of a genuine research project. Also, the law does allow a manufacturer to provide a meal to a practitioner as a 'gift' -- as long as the total value of all gifts provided to the practitioner does not exceed the $50 per year limit."

Besides clarifying some definitions, Wiberg has made all of the disclosure forms available on a CD. He hopes to eventually have all of the data available on the Web.

And what if a manufacturer doesn't comply with the rules? The board can order them to a hearing.

"We really can't take a large manufacturer's license away, for understandable reasons," Wiberg said. "Then they could not ship to the state, which would cause major problems for patients."

However, the board can issue a civil penalty of up to $10,000.

Steven Miles, who is a professor of medicine in the University of Minnesota's ethics and medicine department, said that the disclosure process is incomplete, but it is movement in the right direction.

"The mere fact that the data is now being used publicly is a good thing," he said.

Source: Post-Bulletin