By: Samuel Loewenberg

A push by Democrats for two major overhauls in the food and drug industries could be jeopardized as they encounter industry opposition in the middle of an abbreviated election-year legislative schedule.

At stake are proposals to regulate foreign food and drug imports and to limit drug advertising on television.

The industries’ lobbying strategy appears to use the ticking clock as a point of leverage in their negotiations. Democrats see this as cynical politicking and say that public opinion is on their side.

The biggest fight is over legislation in the House Energy and Commerce Committee that would impose a broad new inspection regime on both food and drug companies, a move triggered by a series of recalls of products imported from China and other developing nations over the past two years. There were 313 alone in the food industry, according to the committee.

The food manufacturers lobby, in particular, is resisting the changes.

“We are very concerned that legislation that taxes food companies and consumers at a time of runaway food inflation has little chance of passage,” said Scott Faber, a lobbyist for the Grocery Manufacturers Association, which represents agribusiness and food processing companies.

“Clearly, the clock is running out on this session of Congress,” Faber said, arguing that the import safety bill would impose new costs on industry that are a “recipe for stalemate.”

A committee spokeswoman said the Democrats were undaunted.

“Our plan is still to do a comprehensive overhaul of FDA to equip it to deal with an increasingly globalized market,” said spokeswoman Jodi Seth. “We’re interested in cleaning up the whole mess, including contaminated heparin and tainted tomatoes. Consumers want all the products they consume to be safe.”

Drug makers, meanwhile, are taking a more conciliatory stance, although they still want their own changes to the legislation.

“The drug industry is already globally regulated, so this does not frighten us the way it does some other industries that are not globally regulated,” said Richard Buckley, a lobbyist for drug maker AstraZeneca.

Part of the difficulty is that the legislation seeks to regulate imports from two different industries, drugs and food, which are themselves already very internally differentiated, said Steven Grossman, a former Reagan administration health care official who is now a lobbyist. Grossman runs a coalition seeking reform of the FDA.

“It made the agreement more complex in a situation when you have a dwindling number of days,” Grossman said, speaking on his own behalf.

The legislation’s Democratic sponsors say what is needed is more regulation, not less, and that especially goes for the food industry.

Last month, the sponsors, Energy and Commerce Committee Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) wrote 49 multinational food processing companies, asking them to detail all of their recalls and chemical or microbiological contamination incidents since 2000.

“Food processors have, for the most part, avoided the kind of regulation and inspections that are imposed on drug and medical device manufacturers,” Stupak said. “We intend to determine exactly how rigorous these large multinational corporations have been in protecting the health of the American consumers.”

The food processors are particularly concerned about user fees for importing food, which would be used to fund the new inspection regime.

Having to hire third-party inspectors at food facilities around the world would be costly and cumbersome for the industry, Faber said.

“There are some parts of the world where it is hard to imagine that anybody but Blackwater would be able to provide third-party certification,” he said, referencing the controversial private security firm that is under investigation for its work for the State Department in Iraq.

Instead, the food industry lobby is pushing a bill authored by House Agriculture Committee member Jim Costa (D-Calif.) and Republican Conference Chairman Adam Putnam (R-Fla.). The food manufacturers favor the measure because it imposes far lower user fees and regulatory requirements than the Dingell-Stupak legislation.

Agribusiness is by far the largest campaign contributor to Costa and Putnam, according to the Center for Responsive Politics. Costa has received nearly $700,000 from the industry since he first ran for Congress four years ago, and Putnam, the third-highest-ranking Republican in the House, has received $775,000 since 2001.

So far, the drug industry is letting the food companies take the lead in opposing the legislation. And drug lobbyists say they are bracing for new regulation.

“One thing you never want to do is bet against John Dingell,” said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. “He is an extraordinarily skilled politician. You should never underestimate his ability to get things done.”

When it comes to cutting back on television commercials, however, the drug industry is not so sanguine.

In May, Dingell’s committee sent a letter to drug companies asking for their compliance with six standards, which included the request that companies not run advertisements aimed at consumers until two years after the drug was introduced and until the drug makers have performed outcome studies on the drugs to examine their full effects.

“Marketing department leaders have failed to commit to reducing misleading and deceptive ads, so we’re now asking the CEOs to make this agreement,” Dingell said.

The FDA first allowed so-called direct-to-consumer advertising a decade ago, making the United States one of only two countries that allow television ads for drugs.

For every $1 a drug company spends on advertising, the companies have a $6 increase in sales, according to the House Energy and Commerce Committee.

Not surprisingly, this request to curtail direct-to-consumer advertising did not go over well with the pharmaceutical industry.

In a letter to Dingell, Jeff Kindler, the chief executive officer of drug industry giant Pfizer, rebuffed many of the committee’s requests.

Waiting to advertise until outcome studies have been performed could be “detrimental to the public health,” he wrote. Such studies are both time-consuming and usually not required before a product is put on the market, he argued, and consumers should be able to receive information as soon as possible.

The company also rejected the two-year moratorium, saying it already waits six months before running ads, enough time to inform doctors about a drug’s dangers and benefits.

Pfizer, along with Merck and Schering-Plough, pulled drug ads in the wake of scandals arising from the committee’s investigations over the past year.

PhRMA, the drug industry trade association, tried to sound a conciliatory note.

“We have concluded that a one-size-fits-all strategy isn’t appropriate in this case,” Johnson said.

Still, he said, the trade association is trying to broker a compromise.

“We are in the process now of taking a second look at the code, even though we just revised it two years ago,” Johnson said. ”We are trying to find the sweet spot, if you will.”

Drug companies and their trade groups spent a record $168 million on lobbying in 2007, a 32 percent increase from 2006, according to a new report by the Center for Public Integrity.

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