Manufacturers of pharmaceuticals, medical devices and other health products spent nearly $182 million on federal lobbying from January 2005 through June 2006, a Center for Public Integrity study of disclosure records shows.

Of that total, drug companies and their trade groups spent most of it, or $155 million, lobbying on a variety of issues ranging from protecting lucrative drug patents to keeping lower-priced Canadian drugs from being imported to the United States Drug interests employed about 1,100 lobbyists to do their bidding in each of the past two years.

Many of the bills targeted by lobbyists for drug interests last year were largely the result of public concerns over high drug prices and safety issues. Drug companies "have been facing an increasingly furious Congress and an increasingly disgruntled public," said Amy Allina, program director at the National Women's Health Network, a women's health advocacy group.

The drug industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) spent more than $18 million on lobbying last year, more than any single drug company and the most the group spent in one year since 1998, the earliest year of this analysis. In all, PhRMA has spent $104 million since 1998.

Among drug manufacturers, Pfizer, the world's largest drug firm, spent the most on lobbying last year — $12 million — bringing its total to more than $62 million since 1998. Merck spent about $48 million and Eli Lilly, Bristol-Myers and GlaxoSmithKline each spent around $40 million in the same period.

The pharmaceutical industry, which mounted a huge lobbying campaign to thwart attempts by states to reduce drug prices, also has spent tens of millions of dollars on campaign contributions and fights over ballot initiatives, a Center for Public Integrity analysis of state campaign funds has found.

Drug company executives, employees and political action committees donated more than a combined $18 million to state political groups and candidates from 2001 to 2004, according to the Center's analysis of data provided by the Montana-based Institute on Money in State Politics. And the industry spent more than four times that much last year for a lobbying campaign on competing California ballot initiatives.

The Center found that Republican groups and candidates received more than $11 million in campaign contributions — greater than 60 percent of the donations identified; Democrats received about $7 million.

Top group recipients of pharmaceutical industry money included the California Republican Party, which received more than $620,000; the Florida Republican Party (more than $610,000); the Senate Republican Campaign Committee of New York (more than $430,000); the New Jersey Republican Party (more than $350,000); the Democratic Assembly Campaign Committee of New York (more than $335,000); the New Jersey Democratic Party (more than $320,000) and the New York State Republican Party (more than $320,000).

Gubernatorial candidates were among the largest individual recipients of campaign money from the industry. Democrat Gray Davis, California's former governor, was the top individual recipient identified with at least $570,000. More than $100,000 apiece also was given to his successor Arnold Schwarzenegger and fellow Republicans Gov. Rick Perry of Texas and Mark Earley, the party's 2001 candidate in Virginia.

Pursuing average savings of 25 percent to 50 percent below U.S. prices, many states have defied the federal government and turned to countries such as Canada for access to affordable prescription drugs for their citizens.

An analysis by the Center for Public Integrity disclosed that 34 states have implemented or considered bills relating to the importation of prescription drugs since 2003.

Almost 100 such bills have been introduced in the last three years in state legislatures, according to tracking by the National Conference of State Legislatures, a bipartisan organization serving state legislators and staffs that advocates state interests before Congress and federal agencies. Those proposals include several resolutions urging Congress and the Bush administration to reconsider the federal stance on importation.

But such state legislative moves are opposed by the pharmaceutical industry and the federal government, both of which claim that there is no way to guarantee that drugs purchased in other countries are as safe as those sold in the United States.

The Food and Drug Administration has said repeatedly that importation would leave the country vulnerable to bioterrorist attacks and other problems due to contaminated drugs, despite studies that have shown that prescription drug regulations in Canada, for one, are at least as stringent as those in the United States.

Meanwhile, pharmaceutical companies also make the vehement argument that when drugs are purchased in Canada and Europe, buyers are importing more than medicine — they're also importing price controls.

Drug companies have tried to block importation in a variety of ways, including through legal challenges. In some instances, they have helped fund groups that ran anti-importation advertisements.

Through an apparent loophole in agency rules the Food and Drug Administration has allowed its employees to receive more than $1.3 million in sponsored travel since 1999 from groups closely tied to pharmaceutical and medical device companies.

FDA policy bars employees from taking trips paid for by the drug, medical device and other companies the agency regulates or by their trade groups. But the Center for Public Integrity has found nonprofit associations that draw their members, their boards and even some of their funding from medical and pharmaceutical-related companies paying for the travel of hundreds of FDA employees.

The sponsor of the most trips was the Drug Information Association, which footed the bill for more than 600 trips taken by FDA employees. The nonprofit group made up of pharmaceutical and medical device employees, academics and government regulators boasts 13 members on its board of directors who work or have worked for the industry or its consulting groups.

At the behest of Congress, the Inspector General of the Department of Health and Human Services has investigated ties between the industry and the agencies that oversee it. Many of the top sponsors have membership or financial ties to medical and pharmaceutical-related companies. Nonprofit groups and universities with such ties paid for roughly a third of the more than 3,600 trips taken by agency officials, suggesting that the industry is indirectly subsidizing the travel taken by employees of the FDA.The FDA has come under heavy criticism since Vioxx and other widely prescribed drugs were recalled for safety reasons. Members of Congress and government watchdog groups have charged that the regulatory agency is too close to the industry it oversees to impartially and effectively police the roughly 10,000 drugs on the market.

Thalomid is a popular treatment for a progressive blood disease known as multiple myeloma—a cancer of the plasma cells that is responsible for more than 10,000 deaths annually in the United States. The drug accounted for more than three-quarters of the $377 million in revenue generated last year by its manufacturer, New Jersey-based Celgene Corp. In fact, the global pharmaceutical company's Web site proclaims that Thalomid is "the current driver of Celgene revenue growth."

According to the Food and Drug Administration, which determines what drugs enter the U.S. market and also oversees their development, manufacturing, marketing and distribution, Thalomid (the brand name version of thalidomide, which in the early 1960s was prescribed in Europe and Canada for morning sickness in pregnant women, then withdrawn from the market after being traced to severe birth defects) was approved to treat a severe skin disorder in leprosy patients. As a result, Celgene may not legally market the drug for any other use, but physicians may prescribe it for other conditions. A Celgene spokesperson admits that Thalomid is most often for off-label uses, rather than the leprosy condition.

As the widespread "off-label" use of Thalomid and several other drugs indicates, the FDA's decree is often not the last word for the industry. In recent years, off-label sales have generated billions of dollars in revenue. Only in one instance was a drug maker penalized: In May 2004, Pfizer subsidiary Warner-Lambert agreed to plead guilty and pay more than $430 million to settle all Justice Department charges related to the off-label marketing of its epilepsy drug Neurontin, which the company promoted as a treatment for everything from migraine and attention deficit disorder to drug-withdrawal seizures and bipolar disorder.

The pharmaceutical and health products industry has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years, a Center for Public Integrity investigation has found. Its lobbying operation, on which it reports spending more than $675 million, is the biggest in the nation. No other industry has spent more money to sway public policy in that period. Its combined political outlays on lobbying and campaign contributions is topped only by the insurance industry.

The drug industry's huge investments in Washington—though meager compared to the profits they make—have paid off handsomely, resulting in a series of favorable laws on Capitol Hill and tens of billions of dollars in additional profits. They have also fended off measures aimed at containing prices, like allowing importation of medicines from countries that cap prescription drug prices, which would have dented their profit margins.Pfizer, the world's largest drug company, made a profit of $11.3 billion last year, out of sales of $51 billion.

The industry's multi-faceted influence campaign has also led to a more industry-friendly regulatory policy at the Food and Drug Administration, the agency that approves its products for sale and most directly oversees drug makers.

Most of the industry's political spending paid for federal lobbying. Medicine makers hired about 3,000 lobbyists, more than a third of them former federal officials, to advance their interests before the House, the Senate, the FDA, the Department of Health and Human Services, and other executive branch offices.

Chances are, the commercial is familiar, seen more often than not at dinnertime: a middle-aged woman begins a discussion by saying, "I can't even believe I'm talking about this."

The "this" in question is her overactive bladder, and the slightly unsettling advertisement is for oxybutinin chloride, better known by its brand name of Ditropan XL. The drug, available only by prescription, is manufactured by Alza, which began promoting it with a print and television campaign in 1999, using a strategy known as direct-to-consumer advertising, which critics contend leads to an overmedicated populace.

The approach's effectiveness in getting Americans to consider drug therapies is well-documented. A study conducted by researchers at Harvard University and the Massachusetts Institute of Technology found that for every dollar spent on direct-to-consumer advertising, drug sales increased by $4.20. In 2000, that translated to an additional $2.6 billion in pharmaceutical sales.

"By raising awareness of overactive bladder as a treatable medical condition," Thomas Bruckman, former executive director of a patients' advocacy organization called the American Foundation for Urologic Disease, said in a press release for Ditropan, "consumer campaigns like this one will help more people seek treatment from a urologist or other physician."

Bruckman's praise—cheerfully quoted by Alza in a 1999 press release touting its launch of the media campaign—wasn't his organization's only testimonial on behalf of the pharmaceutical industry. AFUD's mission is to "raise funds for research, lay education and patient advocacy for the prevention, detection, management and cure of urologic disease," according to its Web site. And over the years, it's been a reliable supporter of the industry.

The pharmaceutical and health products industry has given nearly $150 million to federal and state candidates and parties, along with some political non-profits, in the last four election cycles, according to a Center for Public Integrity analysis of campaign finance records provided by the Center for Responsive Politics and the Institute on Money in State Politics. Sixty-five percent, or almost $100 million, went to Republicans.

Employees and political action committees representing the industry gave nearly $87 million to federal candidates. In the last election cycle, in which the industry gave more than $17 million to federal candidates, President Bush was the top recipient of money from drug interests—receiving more than $1 million.

At the federal level, the industry's political donations peaked in the 2002 cycle. That was the last election before the so-called soft money was banned by the McCain-Feingold law. Soft money—which at the time could be given without limit by corporations, individuals or unions—accounted for two-thirds of that total. Twelve pharmaceutical companies contributed more than a million dollars in that cycle. The industry trade group, Pharmaceutical Research and Manufacturers of America, contributed another $3.5 million. In comparison, just two companies donated more than a million in the last election cycle.

It is no surprise that the largest companies are the top contributors. Pfizer gave the most for the 2004 election cycle, donating $1.6 million to federal candidates and political parties. Other top contributors were GlaxoSmithKline ($1.1 million) and Eli Lilly (just under $1 million).

2008

On Jan. 1, the administration of vaccines (in addition to the cost of the vaccine itself) is included in the coverage of Medicare Part D drugs.

In June, House Democrats announce plans to introduce legislation preventing FDA regulation from trumping medical device patients' ability to seek damages under state law.

2007

On Jan. 3, Speaker of the House Nancy Pelosi and House Democrats release their agenda for the first 100 hours of the legislative session, planning to enact a bill that will allow the Secretary of Health and Human Services to negotiate directly with pharmaceutical companies to negotiate lower prescription drug prices for Medicare beneficiaries. The Senate has not acted on the measure.

In mid-January, a bipartisan Congressional contingent announces plans for legislation to allow importation of prescription drugs from Canada and other foreign countries, estimating that consumers could save $50 billion over the next ten years if the measure is passed.

In April, patent reform legislation is introduced in the Senate to improve the U.S. patent system. Despite support from high-tech and communications companies, the measure is opposed by the pharmaceutical industry because of the possibility that it would weaken patent protections by reducing infringement penalties. The bill was reported out of committee but has not made it to the Senate floor.

In May, a drug-import plan that would have eased the process of importing cheaper prescription drugs into the country from Canada and other foreign countries is defeated during Senate debate on a bill designed to strengthen the FDA.