By Alexander Bolton - 05/09/12 12:55 AM EDT
A lobbyist for a generic drug company was introduced as a special consultant to Sen. Jeff Bingaman (D-N.M.) during negotiations on patent law, according to others who attended the meeting.
The incident took place last week when pharmaceutical-industry representatives were invited to Bingaman’s offices to voice their objections to his proposal to expand market access for generic drug companies.
The introduction struck the industry representatives as unusual because while congressional campaigns often employ consultants, it is highly unusual for Senate offices to do so.
As the meeting wrapped up, Giuli handed out his card identifying himself as director of government affairs and industry relations at Apotex Corp., which markets products for Apotex Inc., one of the largest generic drug manufacturers in the world.
Apotex supports Bingaman’s bill while several domestic generic drugmakers and PhRMA, the trade association that represents brand-name drugmakers, oppose it.
The drug industry representatives who went to Bingaman’s office to voice their concerns about the legislation were stunned to discover the person they thought was Bingaman’s consultant turned out to represent a major private-sector competitor.
Giuli strengthened the impression that he worked for Bingaman by describing the senator’s views throughout the meeting, according to sources familiar with the meeting.
The standard protocol on Capitol Hill is to identify meeting participants up front. If someone is not identified as belonging to a different office or outside group, they are assumed to be part of the team hosting the meeting.
Jock Friedly, president and founder of LegiStorm, a website devoted to improving congressional transparency, said the incident raises ethics concerns.
“If this report is true, a lobbyist was passing himself off as part of the lawmaker’s staff or team, which is troubling,” he said. “There is an ethics rule that prohibits the use of volunteer labor for this very reason. You can’t just have somebody providing their time.”
Friedly noted there are exceptions, such as for interns, who work without pay in exchange for educational benefits. But those exceptions do not cover lobbyists for generic drug companies.
Jude McCartin, a spokeswoman for Bingaman, said Giuli has consulted with Bingaman’s staff on the legislation but emphasized he does not speak for the senator and is certainly not a member of his staff.
“Clearly, we consulted with him — we consulted with a lot of people, an awful lot of people,” she said.
McCartin said she did not know what title or description was used to introduce Giuli nor whether he passed out his card at the beginning of the meeting or at its end.
She said it was at most a misunderstanding and suggested it was being exploited by opposing lobbyists who want to kill Bingaman’s bill, which sponsors say would save taxpayers and consumers hundreds of millions of dollars.
“You can see where these kind of things happen,” she said. “I can see where really busy people assume introductions were made. Clearly this was not a Bingaman staffer.”
Giuli did not respond to requests for comment left on his cellphone.
Friedly said he does not remember any instance of lawmakers using a consultant in recent years. He recalled one former congressional leader got into trouble for relying on a former staffer who was on a lobbying firm’s payroll.
Bingaman’s bill, introduced with Sens. Sherrod Brown (D-Ohio), David Vitter (R-La.) and Jeff Merkley (D-Ore.), would help generic drugmakers bring lower-priced prescription drugs to market more quickly.
Current law limits the number of generic drug companies that can bring products to the market during the 180-day exclusionary period after a patent expires. This access is reserved for generic drug companies that go through the expensive and time-consuming legal process of challenging the expiring patent.
Bingaman’s bill would expand the number of companies that can market generic drugs within six months of a patent expiring.
“Unfortunately, in many instances, the ‘first-filer’ is paid or settles with the name-brand company to delay selling their generic drug. This leaves only the expensive brand-name drug on the market, while both the name-brand company and the generic company financially benefit,” the sponsors explained in a November press release.
They estimate the bill will save consumers hundreds of millions of dollars.
PhRMA and domestic generic drug manufacturers oppose the bill because it cuts into their profits. Apotex likes it because the measure would let it come to market sooner without wrangling in the U.S. courts.
In addition to Apotex, the bill’s supporters include Wal-Mart, Families USA, U.S. PIRG, the Consumers Union, the Consumer Federation of America, the Center for Medicare Advocacy, the National Legislative Association on Prescription Drug Prices and the Alliance for Retired Americans.
Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pensions Committee, said he is undecided.
“This is very nuanced. I think Bingaman is on the right track on this. Something’s got to be done to close this sweetheart deal that generics sometimes have with brand-name drugs,” said Harkin. “Whether his formula is right or not, I don’t know.”
Bingaman is expected to introduce his legislation as an amendment to the reauthorization of the Prescription Drug User Fee Act.
Senate Majority Leader Harry Reid (D-Nev.) said Tuesday he will bring the reauthorization bill to the Senate floor before Memorial Day.