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When the Food and Drug Administration went hat in hand before Congress this year, hoping to sell the legislators on a funding increase for the agency, it didn’t go alone. In an unexpected role reversal, the business community, which often rails against its government overseers, played ally to the agency. Drug manufacturers, biotech pioneers, and food companies lobbied for the FDA, using a campaign that ranged from letters to Congress to personal meetings. While industry lobbyists won an extra $3.2 million for the agency to hire more personnel and buy more equipment for the Office of Generic Drugs, they also helped themselves. With more staff to review applications, drugs should move through the agency and into the market at a faster pace. “From the industry perspective, the quicker we can get approvals the happier we are,” says Jake Hansen, vice president of government affairs for Pomona, N.Y.-based Barr Laboratories, which produces generic drugs. “From the public health standpoint, the quicker we get approval, the quicker the public can get new, healthy drugs. In both cases, it’s a win-win situation.” It’s a relatively rare occurrence — the regulated lobbying for the regulators. More typical is the scenario where business expends its political clout to limit an agency’s spending. Already this year, the appropriations bills are littered with riders that tell various agencies how not to spend money. A rider from Sen. Ernest Hollings, D-S.C., bars the Federal Communications Commission from spending money to grant licenses to companies with more than 25 percent foreign ownership — a provision aimed squarely at Deutsche Telekom, which recently announced its intention to buy the VoiceStream Wireless Corp. The Occupational Safety and Health Administration will be barred from unveiling its new ergonomics regulations if a spending rider goes through. But other companies find it more useful to fight for their regulatory agency — and, by doing so, help steer money into areas that will be the most beneficial to them. Corporate human resource professionals are fighting to fund an Equal Employment Opportunity Commission mediation program which will cut down on the time and money companies have to spend battling discrimination complaints. Another case in point: the Patent and Trademark Office. When the House Appropriations Committee slashed $295 million from the PTO, the usually low-key intellectual property community sprang to the agency’s defense. A coalition of groups led by the Intellectual Property Owners Association contacted lawmakers to protest the cuts, and 39 chief IP counsel, general counsel, and other corporate officials sent a letter to Congress, as did the industry group Technet. Prior to the House floor vote, the association called for “a blizzard of last-minute calls to U.S. Representatives.” The Senate committee that handles the PTO’s budget awarded the agency $1.167 billion — $80 million more than the president’s request. And the IP association is taking credit. “In many cases, like the Patent and Trademark Office, the industries that rely on the agency don’t want the budget cut, they just want it used in certain ways that they want,” says Stan Collender, senior vice president and managing director of the Federal Budget Consulting Group at Fleishman-Hillard Inc., the mammoth, St. Louis-based PR firm. But it is also a lobbying technique that makes agency watchdog groups nervous. If industry supports the agency, they ask, how good of a job can the agency be doing to regulate industry? And nowhere is that more evident than for the FDA. “As far as we can tell, the industry’s love affair with the FDA is closer than ever,” says Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Industry loves what the FDA is doing, which should not be the case for a regulatory, policing agency.” GETTING ORGANIZED For years, companies have lobbied for more funding for the FDA, namely in the approval area, where the agency’s limited resources can translate to a hit on a company’s bottom line. But this year, industry was more organized. BIO, the biotechnology trade group, circulated a letter to Congress, backing full funding of the FDA. The letter was signed by 11 trade associations, including the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Industry Organization, and the Grocery Manufacturers of America. “We wanted to make it clear that there was a group of organizations that, regardless of individual agendas, all believe in more funding for the agency,” says Michael Werner, director of federal government relations at BIO. “We have been noticing that the FDA has not been getting the funding increases it needs.” The letter’s effectiveness is debatable. The agency received $66 million less than requested in the House version of the bill and $90 million less than in the Senate’s version, by Congress’ budget estimates. But industry was far more effective in winning increases for selected arms of the agency. Funding for generic drug approvals is the perfect example. According to the office of Sen. Orrin Hatch, R-Utah, who is a champion of cheaper pharmaceuticals, the Center for Drug Evaluation received $308 million last year. But the Office of Generic Drugs received only a fraction of that money — $37.8 million. “I think that you can lay this at the FDA,” says David Weeda, general and legislative counsel for the National Association of Pharmaceutical Manufacturers. “I don’t think they have an intense lobbying effort for the Office of Generic Drugs. They have a billion-dollar budget, but FDA is an expensive place to run. They have to worry about foods, medical devices, biologics, and everybody is crying for money.” So if the agency wasn’t going to make enough of a case, the manufacturers were. The trade groups met with Appropriations Committee members, laying out budget numbers and telling them how valuable generic drugs are to cost-conscious voters. The House awarded an additional $1.5 million to the budget for generic drugs. The Senate allotted $1.2 million. OPEN HATCH In the meantime, Hatch contacted Barr Laboratories, according to the company, and asked what generic manufacturers needed. The company had one answer — more funding for the FDA’s office. That is the same answer that Hatch heard from a number of drug manufacturers, consumers groups, and senior citizens organizations he spoke with, according to his office. Once the FDA’s appropriations bill made it to the Senate floor, Hatch and Sen. Richard Durbin, D-Ill., stepped in with the biggest award — $2 million. “We intend these funds to provide much-needed resources, that is, appropriately equipped staff, to the Office of Generic Drugs,” Hatch said during a debate on his increase. “This will help them reduce review times for generic alternatives to brand-name pharmaceuticals, a considerable benefit to the consumer.” Lobbying by other industry groups, such as the Consumer Healthcare Products Association, helped win other increases in the agency’s budget, including bump-ups for the dietary supplement office and the FDA’s adverse event reporting system. The House and Senate will confer on the two bills in September. “It’s in our interest and the public interest for [the FDA] to do a good job,” says David Keaney, director of federal government relations for the New York-based Bristol-Myers Squibb Co. “When you are talking about drugs, it is very important that the public perception be that our drugs are safe, and that perception is there when they get approval from the FDA. It behooves us to make sure it continues to be that way.” Legal Times News Editor Jenna Greene contributed to this report.

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