WASHINGTON — Drug makers spent $155 million lobbying the federal government from 2005 to mid-2006, setting a record that they could top this year as Congress considers high stakes legislation for the industry and consumers, a public interest group said in a report Monday.
Researchers at the nonpartisan Center for Public Integrity said that the drug industry spent nearly $111 million on lobbying in 2005, a record for the sector in any one year. The record pace appeared to be sustained in the first half of 2006, the report said.
Pharmaceutical industry officials said the report distorted the industry's role in Washington, which they say is primarily educational and scientific. They said industry spending was designed to ensure that new drugs for intractable illnesses get government approval to be marketed.
"The Center for Public Integrity's report, not surprisingly, misses the mark when it comes to efforts by America's pharmaceutical research companies to educate policymakers," said Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America. "Our priority has always been to help advance patient health and ... we have supported policies and programs that bolster patient access to safe and effective medicines."
Lobbying is only one facet of the industry's influence. Drug company sources also accounted for more than $19 million in political contributions to candidates in last year's congressional election, mainly Republicans. And user fees paid by drug makers make up more than half the budget of the Food and Drug Administration centers that evaluate new drugs.
The industry's budget enabled drug makers to field about 1,100 agents to lobby congressional committees and administration offices in each of the last two years, the study said.
The industry achieved several of its major objectives, the report added, including upholding the government's ban on imports of lower-cost medications from abroad.
"Essentially what they did is they blocked any legislation," said M. Asif Ismail, director of the center's project to monitor the drug industry. "There have been several attempts to revisit this issue, and importation is still illegal."
With strong support from the Bush administration, the industry also appears to be in a position to make sure the prohibition against Medicare negotiating drug prices for seniors in its prescription program remains intact.
These battles are expected to be fought more fiercely this year because Democrats now control Congress. In the past, senior Republican leaders were able to keep import legislation from getting a floor vote.
"The industry is going to spend more money this time than the record amount that is reported by the center," said Dr. Sidney M. Wolfe, director of the consumer watchdog Public Citizen's Health Research Group. "From the perspective of the industry, this money is extremely well spent, because they have used it to win virtually every important battle."
The industry's clout will be severely tested in coming months.
Legislation authorizing the FDA's user-fee system will expire this year unless Congress acts. Such must-pass legislation often attracts amendments. Reforms to strengthen the FDA's drug safety system are expected to be part of the bill. And supporters of lifting the ban on pharmaceutical imports also are eyeing the user-fee bill as a vehicle.
Sens. Byron L. Dorgan (D-N.D.) and Olympia J. Snowe (R-Maine) have introduced legislation that would allow U.S. consumers to import cheaper prescription drugs from Canada. "They have a history of looking for vehicles to attach this legislation to, and I would expect that to continue," said Barry Piatt, a spokesman for Dorgan.
The industry is approaching the debate by offering carrots and sticks.
It has agreed to hefty user-fee increases that would pay for new safety reviewers at FDA and help set up a computerized surveillance system to aid in detecting harmful side effects in new drugs. But it is vowing to fight legislation allowing imports, arguing that it would lead to a flood of fake drugs.
"The bills will in all probability end up importing what has become a counterfeit epidemic around the world into the United States," W.J. "Billy" Tauzin, a former Louisiana congressman who is the industry's top lobbyist, said during a recent discussion with reporters. "Congress is looking at an importation bill that would bust open the biggest safety protections we have."
Asked if the industry would withdraw its support for an extended user-fee agreement if Congress added on objectionable amendments, Tauzin said it was too early to say.