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Pharmaceutical disclosure rules pulled, worrying advocates

CHARLESTON, W.Va. -- Rules for enforcing a 2004 state law requiring pharmaceutical companies to disclose spending on advertising and marketing of brand-name drugs in the state have been withdrawn by Gov.-elect Earl Ray Tomblin's administration -- raising concerns among advocates of the sunshine law.

According to the State Register, Tomblin officials withdrew the rule for Prescription Drug Advertising Expense Reporting late last month.

Tomblin spokeswoman Kimberly Osborne said the rule, which went into effect in 2010, was withdrawn over concerns it had changed the filing requirements for drug manufacturers from the original 2006 rule.

"It would have changed filing requirements that prescription drug companies would have had to abide by," Osborne said Monday.

Under state law, agencies adopt rules spelling how they will carry out legislative mandates. Under the rule-making review process, those rules have to be formally approved by the Legislature before they go into effect.

The 2010 rule made two changes to the 2006 rule, allowing for electronic filing of reports and clarifying that the reports are to be filed with the Governors Office of Health Enhancement and Lifestyle Planning (GOHELP), rather than with the now-defunct office of the state Pharmaceutical Advocate.

Sen. Dan Foster, D-Kanawha, a physician and a key legislative advocate for the pharmaceutical spending disclosures, said Monday he was concerned that the rule had been withdrawn, particularly since there had been little or no advance notice to legislators.

"There seems to be a lack of transparency about how this was done," he said.

"I don't think that they talked to anybody in the House about this," said Foster. "[House Health and Human Resources Chairman] Don Perdue and I were very much involved in the initial legislation in 2004."

Foster said it is important that pharmaceutical companies be required to disclose what they are spending to encourage consumers to request -- and doctors to prescribe -- expensive brand-name prescription drugs.

"If we don't do things to control pharmaceutical costs, it's going to cost us more for PEIA and other programs," he said.

Osborne said the rule also was withdrawn to allow the next director of GOHELP to have input in any rule changes.

"We withdrew it because we want to have input from whoever becomes director," she said.

Martha Walker retired as GOHELP director July 31, and a successor has yet to be appointed.

There have been three financial disclosure reports published since the rule went into effect.

The first, by the Pharmaceutical Advocate and covering the last six months of 2007, disclosed that pharmaceutical companies had spent more than $16 million in direct-to-consumer advertising and for nearly 15,000 "gifts, grants or payments" to state physicians, ranging in amounts from $50 to $52,000.

The next report for calendar year 2008, showed more than $33.2 million in expenditures, including nearly 16,000 gifts, grants or payments. Four physicians received payments in excess of $100,000, according to the report.

The most recent report, for calendar year 2009, cited total spending of $28.6 million, of which $7.7 million was on direct-to-consumer advertising.

That report, the first prepared by GOHELP, was two pages long and did not provide a breakdown of payments to providers by payment categories.

Reach Phil Kabler at philk@wvgazette.com or 304-348-1220.


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