Broad Lobbying Begins in FDA Overhaul Effort

Broad Lobbying Begins in FDA Overhaul Effort

Rep. John D. Dingell is putting his considerable clout behind an ambitious import safety and Food and Drug Administration overhaul bill. But the opposition it is generating from almost every corner of the business world may prove to be a formidable counterweight.

From local port authorities to the seafood industry — with drugmakers and grocers in between — private industry groups and lobby organizations are concerned about the draft bill’s dozens of new regulations on drug and food imports and safety.

“It’s shotgun,” said Carl Nielsen, former head of import operations for the FDA. “It seems like . . . they just made a litany of every possibility.”

Dingell, D-Mich., is planning to hold Energy and Commerce Committee hearings on the draft bill and plans to mark it up in the next few weeks. But the first step in the process comes Thursday, in a hearing before the Health Subcommittee, chaired by Frank Pallone Jr. , D-N.J. Food safety advocates, as well as FDA staff, will share their thoughts before what is expected to be a capacity crowd in the Rayburn House Office Building hearing room. The hearing, said a spokeswoman for the committee, is “generating a ton of interest.”

The Dingell bill is still in draft form and still could be changed before he formally introduces it. The spokeswoman said the committee decided to go forward with the draft as a way to gather input and reactions rather than pull together lobby groups ahead of a formal bill introduction.

But some still wonder what Dingell and the committee ultimately have in mind.

“Do they intend freestanding legislation, or do they intend lots of warning shots across the FDA’s bow to get them to take some action?” asks Mark Scheineson, a former associate FDA commissioner who now heads the food and drug practice at the law firm Alston & Bird. “A lot of these provisions already exist within the FDA’s authority,” he said, adding that a larger question is whether Congress can provide resources to implement them.

Perhaps. But Dingell’s bill may still have a lot for industry to dislike. The measure would set up user fees for all domestic and foreign drug and food producers, using the hundreds of millions of dollars in fees to set up a new inspection and safety corps in the agency. Foreign drug producers would have to be inspected every two years, and new rules would govern how imported food and medical products could enter the United States.

Dingell has promised to move the bill quickly, but some say that could be a false promise. “Doing something over pharma or food processors and grocers is kind of heavy lifting, especially when you have a pro-business administration that would veto it,” said Scheineson. The Senate has shown interest, with a parallel hearing Thursday in Sen. Edward M. Kennedy ’s Health, Education, Labor and Pensions Committee. But it is unclear if the Massachusetts Democrat’s priorities are in line with Dingell’s.

Grocers, farmers and food safety experts all agree the nation needs a structured import safety system, but financing such a system is a point of contention. Dingell’s bill would levy a $2,000 fee on all food producers. The provision would recoup about $600 million for the FDA, more than doubling the agency’s food safety budget.

Grocers, Generics and Giving

Scott Faber, vice president for federal affairs at the Grocery Manufacturers Association, said the food industry shares Dingell’s determination to pass legislation this year, but he says the existing proposal “will dramatically increase the cost of producing food at a time of record-high food prices in return for virtually no improvement on the safety of food.”

An aide to a Democratic member on Energy and Commerce said the grocery manufacturing lobby has already been reaching out to lawmakers. “They’re not so excited about the user fee stuff. They think it’s kind of a tax,” said the aide.

Broad Lobbying Begins in FDA Overhaul Effort

The seafood industry, represented by the National Fisheries Institute, says the user fees are redundant in its case. “There’s a lot of importer fees, inspection fees, that we think it’s too much,” said spokesman Gavin Gibbons. The seafood industry, he said, already has FDA-approved inspection processes that do enough for product safety. “We’re not against inspections, because we know we’re going to pass, but we are against paying for them,” Gibbons adds.

The generic pharmaceutical industry isn’t happy either, especially about the proposed creation of an inspection regime that would require foreign drug plant inspections every two years.

Many generic and brand-name drugmakers manufacture or import drugs from abroad, where regulatory environments are weaker. Some overseas suppliers have operated without incident, but others have had difficulties — like the producers of the raw ingredients for the blood thinner heparin, which was recently implicated in dozens of patient deaths. Drugmakers want the FDA to focus hardest on these higher-risk manufacturers, rather than making companies with a clean track record share the burden.

“We should create legislation that’s risk-based,” said Andrew Hofelich, spokeswoman for the Generic Pharmaceutical Association.

According to an aide to a Democratic committee member, brand-name drugmakers, represented by the Pharmaceutical Research and Manufacturers of America, and medical device makers, represented by the Advanced Medical Technology Association, have all asked to speak with members. “Those meetings have really just started,” emphasized the aide.

Campaign money will be flowing, as well.According to, which tracks campaign contributions, pharmaceutical and health products companies so far this election cycle have contributed $1.1 million to Energy and Commerce members, evenly split between Democrats and Republicans, with $113,000 to Dingell.

Points of Entry

It’s not just drug and food manufacturers who are worried about provisions in the bill, though. The American Association of Port Authorities is concerned about a provision in the bill that would limit some food and drug imports to ports that have a local FDA inspection facility. Meredith Martino, the group’s government relations manager, said her organization is worried that limiting goods to just a few points of entry will drive up costs and road traffic, as importers are forced to ship to one port and then truck their goods to their final destination.

Farmers, like grocers, are puzzled by the concept of restricting ports of entry for non-certified exporters. Ron Gaskill, congressional relations director at the American Farm Bureau Federation, contends that many countries have already established safety infrastructures for shipping foods, and thus could ensure safety at the point of shipment. “It just doesn’t make sense to throw that infrastructure away” in an attempt “to control, somehow, some way, entry of food,” he said.

Another controversial proposal would mandate that all produce and processed-food labels display the country in which final processing of that food occurred.

Gaskill said manufacturers cannot be expected to relabel products every time they switch suppliers, which they frequently do when suppliers stop carrying certain ingredients. He suspects the end result of country-of-origin labeling will be “a kind of a boilerplate piece” that may not be useful to consumers.

Nielsen, the former FDA import director, also disagrees with the idea of broad country-of-origin labeling.

“I just don’t see it as meaningful,” he said. “Quality and safety is facility-specific, not country-specific. Just because something bad comes out of China doesn’t mean everything is bad. Bad things come out of here.”

Did You Know?

  • The FDA oversees 80 percent of the nation''s food supply, but only recieves 20 percent of food safety funding?
  • HACCP (Harzard Analysis and Critical Control Point) was originally developed for NASA to ensure the safety of food for consumption in space?
  • The FDA''s entire budget is actually less than the budget for the school system in Montgomory County, MD, where FDA resides?
  • Some in Congress would impose "User Fees" on Food Companies as a way to increase FDA''s budget. Such "fees" are really just new taxes on food and would undoubtedly be passed through to the consumer by way of higher food prices.
  • Current customs law already requires the importers of finished, packaged products, seafood, and some bulk foods to include country of origin labeling on the package. Beginning in 2008, fresh fruits and vegetables imported into the U.S. will also need to display their country of origin.