Lobbyists take aim at generic biologics

WASHINGTON -- Urging caution on a bill that would permit marketing of cheaper generic versions of biologic therapies, Representative Thomas Davis III directed attention to an image on oversized television screens set around the hearing room -- a diagram of a massive protein looming over a tiny, much simpler protein.

Davis's message was as simple as the image was complicated: Generic biologics are too complex to approve without first conducting clinical trials.

The image may have been familiar to many of Davis's fellow lawmakers. The same slide is part of a PowerPoint presentation that James C. Greenwood , a former congressman now leading the Biotechnology Industry Organization , has been showing in his lobbying campaign.

Pharmaceutical and biotechnology industry lobbyists trying to slow passage of the legislation are getting help from a few well-placed friends of industry. In congressional hearings, the most vocal opponents have been echoing concerns expressed by the powerful industry lobbies: To ensure patient safety, these newest generic products must undergo clinical trials before Food and Drug Administration approval. They also argue that clinical trials may be needed after approval to make clear whether a branded product or a generic is responsible for side effects that crop up.

Davis , who PoliticalMoneyLine says has received $380,497 from health-related political action committees since 1994 , in an interview said the pharmaceutical and biotech industry lobbies have reached out to him. But the Virginia Republican added that he's also sought their input.

"If you don't have legislation that specifically addresses this, we're not going to get the innovation that I think the country needs. We're going to need a bill," Davis said. "If you want to encourage innovation, we need to get it right. The alternative is a lot of this research can go somewhere else, maybe Europe, or it's not developed at all."

Pharmaceutical , medical device and other health product companies plowed nearly $182 million into lobbying Congress from January 2005 through June 2006 , the Center for Public Integrity reported this month. From July to December last year -- which includes the run-up to midterm elections that propelled Democrats to the majority in the House and Senate -- the Pharmaceutical Research and Manufacturers of America tallied $8.8 million in lobbying expenses, according to PoliticalMoneyLine .

"I never saw a more powerful domestic economy lobby than the pharmaceutical lobby. They are pervasive. They've got so much money," said William Vaughan , a senior policy analyst at Consumers Union with 36 years of Hill experience.

Senator Orrin G. Hatch , a Republican from Utah, since 1980 has attracted $1.4 million in healthcare PAC contributions, including from pharmaceutical manufacturers, according to PoliticalMoneyLine . Hatch makes it clear that he's advocating strongly on behalf of biotechnology industry pioneers, saying that the legislation too heavily favors generic manufacturers and could "stultify" innovation.

The legislation's sponsors are "more interested in spurring on the generic industry -- which is important to me," Hatch said. "The generic industry loves it. But it's penny-wise and pound-foolish."

Hatch and Representative Henry A. Waxman , Democrat of California , earlier co sponsored a bill that speeds to market generics that are chemical equivalents to branded products, saving consumers billions .

Hatch said that bill took a more balanced approach that rewarded innovation at the same time it lowered barriers for generics.

"Unless we can balance both sides, we are going to really hurt the development of the follow-on biologics," Hatch said.

Asked about industry lobbying on the bill, Senator Richard M. Burr , a North Carolina Republican and a critic of the current legislation, said he had not been lobbied. Burr quickly pivoted.

"Well, if 'educated' is lobbied, I've met with everybody who wanted to meet and I've reached out to folks who I felt were knowledgeable," said Burr.

The $399,551 that he's received from healthcare industry PACs since 2004 -- which includes pharmaceutical political action committees -- has no bearing on his go-slower stance toward generic biologics, Burr said. "It does not [bear] on this bill. It does not [bear] on my decision on any piece of legislation, but it is a valuable tool to reach out to industry to understand the process as best we can."

PAC money is just part of what drives stiff opposition to the current legislation, Consumers Union's Vaughan said. Such members as Burr represent districts where pharmaceutical and biotechnology industries are major employers and others, such as Davis and Hatch , seek to ensure that the innovator industry makes enough profit and enjoys sufficient patent protections to keep those economic drivers located in the United States.

"There is a world view. And there are some other things that you can attribute this to," Vaughan said.

Another vocal opponent, Representative Darrell Issa , Republican of California , said that he's been approached by industry lobbyists and Amgen Inc. Analysts have already begun to pare revenue forecasts for the California-based biotech heavyweight's anemia remedies Aranesp and Epogen because the generic biologic bill is expected to pass earlier than anticipated.

Issa, like industry lobbyists, points to potential safety problems that could occur if generic biologics are released without first undergoing clinical trials. In future hearings, he said he intends to prod the FDA to prove it has the scientific expertise to handle the approvals.

"The stakes are very high," Issa said. "To pretend that we don't need clinical trials . . . flies in the face of common sense."

Diedtra Henderson can be reached at dhenderson@globe.com.