AG's opinion could sway pharmaceutical council

CHARLESTON – An opinion from the state Attorney General's office could end up bringing big changes to the way drug companies operate in West Virginia.

A move to have the drug companies disclose what they spend in the state on marketing will be brought before the state Pharmaceutical Cost Management Council again next week.

Kevin Outterson, a West Virginia University law professor who is on the council, said he plans to ask to have a section of the financial disclosure form restored after Darrell McGraw's office issued an opinion saying the council has the authority to demand the information.

The AG's opinion, written by Chief Deputy Attorney General Fran Hughes, said it was clear the Legislature's intent in the Pharmaceutical Availability and Affordability Act of 2004 was to require full disclosure of all advertising and marketing costs by drug companies doing business in the state.

Outterson said the council previously voted 5-4 to delete that section from the disclosure forms.

"Many of the people who voted that way then didn't think we had the authority," he said Tuesday. "Now, with the attorney general's opinion, I think several members of the council now will change their vote," he said.

"Some will change their votes because what was publicly stated as the major stumbling block has now been largely reduced or eliminated."

Outterson said he'll bring the issue up again at the council's meeting scheduled for July 28. At that meeting, the council will give final approval of disclosure rules for drug companies.

A letter to the council from Sen. Dan Foster, D-Kanawha, has asked the council to revisit disclosure requirements for sales representatives, and for direct gifts, grants and payments to physicians, in light of the opinion.

"It was the Legislature's decision to ask for disclosure of marketing information," Outterson said. "The state pays millions of dollars (for prescription drugs) through PEIA and Medicaid. When government buys things, they use that kind of procurement power.

"Nationwide, $280 billion is spent on pharmaceuticals. We suspect more of that is on the marketing, sales and administrative costs than on research and development. That's the reason why we're paying the higher prices is, theoretically."

Outterson also said drug companies outman the state in terms of getting their respective messages across.

He said the state has three positions for pharmacists meant to talk to doctors about prescribing the most suitable drugs for the circumstances. He said those three positions are there to "undo the damage, so to speak, of the drug reps."

But, he said all three of those positions currently are vacant.

"The people in those positions were hired away by drug companies," Outterson said. "We suspect the drug companies have hundreds doing the opposite of what we need. They're getting doctors to prescribe the most expensive drugs."

Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America (PhRMA), said America's pharmaceutical research companies are committed to working with the state to improve access to prescription drugs.

"More than 60,000 West Virginians have been helped by the prescription drug clearinghouse Rx for West Virginia which matches people with programs that provide free or nearly-free prescription drugs," he said Thursday in a statement to The Record. "Rx for West Virginia was so successful that the program was expanded nationally and became known as the Partnership for Prescription Assistance more than a year ago.

PhRMA represents the country's leading pharmaceutical research and biotechnology companies.

"Over the past few years, we have worked closely with the Pharmaceutical Cost Management Council on a number of topics, and we expect to continue to do so," Johnson said. "We will file comments on the Council's proposed marketing rules next Friday."