Drug makers lobby US to hike FDA funds

James C. Greenwood, a former congressman now paid by the biotechnology industry to influence legislators, stood before an audience at the Massachusetts Biotechnology Council's annual meeting recently and outlined his next challenge: getting Congress to increase Food and Drug Administration funding.

Greenwood displayed a chart indicating zero growth in congressional appropriations to the FDA from fiscal years 1986 through 2006.

In sharp contrast, fees paid by the drug industry to the FDA to speed promising treatments to market have doubled from 1998 to 2005 , Greenwood said. Now, the FDA wants pharmaceutical companies to pay even more to help it better ensure drugs that patients take are safe.

Greenwood and others in the drug industry acknowledge the FDA is chronically underfunded and stressed by new responsibilities such as planning for a flu pandemic . And they agree adequate funding for drug safety is an admirable goal.

The industry just doesn't want all of the money coming out of its pocket . But persuading Congress to its point of view could be a hard sell, and as more and more new drugs come into the testing pipeline, debate is intensifying over who will foot the bill.

``Very simply, FDA is drowning under the weight of its added responsibilities and its budget woes, and it sees [user fees] as its life line," said Greenwood, president of the Biotechnology Industry Organization , a group that lobbies on behalf of the biotech industry.

In fiscal 2004, drug companies paid $232 million in fees to the FDA, accounting for 53 percent of the agency's $436 million budget for new-drug review . The 2007 budget includes $320.6 million in fees to be paid by drug makers .

With help from patient advocates , physicians, Democrats, and Republicans, the industry said it will press hard for ``adequate" appropriations , Greenwood said.

The FDA is pushing hard, too, for even more funding from drug makers to help shore up its faltering oversight of safety. Six years ago, a former FDA commissioner estimated the price tag for adding needed drug safety personnel and other improvements at $100 million , but Congress did not appropriate the funds.

``Although we would get questioned very strongly and sharply about why the agency wasn't doing a better job in the postmarket area and why did we have to recall all these drugs, we never saw money for it," said Dr. Jane Henney , FDA commissioner from late 1998 to early 2001 .

William Hubbard , an associate commissioner who retired from the FDA last year after more than 25 years, said he was routinely ignored or denied when he made such requests.

``I can't tell you the number of times that I would go to the department in the White House and ask . . . and be told either, `We'll think about it' -- which is `We'll think about it forever' -- or just flat `no,' " Hubbard said.

The user fee act, approved by Congress in 1992 , was reauthorized in 1997 and 2002 . Since its enactment, it has permitted the FDA to increase its staff to review new drugs from 1,277 in 1992 to 2,503 in 2004 .

Every 100 additional reviewers shortened the time it took the FDA to consider a new drug application by 3.4 months , according to Harvard University government professor Daniel Carpenter . Even the most promising lifesaving drugs took 16.3 months to review in 1993 . Last year, the median time for review and approval was six months for high-priority drugs .

Many would like to see the same kind of progress made in how the FDA monitors the safety of drugs after they go to market.

Carpenter supports using industry fees to finance such drug safety endeavors as clinical trials that compare drugs within a class -- like cholesterol-lowering statins . Because the industry has funneled so much money toward rapid FDA approval, it could polish its credibility by funding the other side of FDA's mission, he said.

``The industry would probably build itself some political and reputational capital," Carpenter said.

Negotiations between the FDA and drug makers over user fees will continue behind closed doors through Labor Day , but some are taking the battle public through fiery statements like those Greenwood made in Boston.

``The industry is really feeling like there is a steady progression toward them paying it all," Hubbard said, referring to the steady increase in the proportion of drug industry funding for the review of new drugs, from 20 to 53 percent in the past decade.

Lifting a line from their critics, drug makers say they worry about public perception should they increase their contributions .

``Even when they were 20 percent, we've seen the critics over and over again say, `Oh, look, the pharmaceutical companies are buying approvals,' " Greenwood said .

Eli Lilly & Co. chief executive Sidney Taurel said recently that for the FDA to be ``perceived as independent" the funding it receives from drug companies should be limited.

Part of the industry's motivation to set the tone on the public debate over FDA funding is the impending introduction of a bill by Edward M. Kennedy of and Michael Enzi of Wyoming , the top Democrat and Republican on a Senate committee with FDA oversight. Among other goals, the measure would give the FDA power to require label changes to warn patients of newly uncovered drug risks and would force drug makers to conduct postmarketing studies of treatments. The bill would increase industry fees to pay for the upgrades .

Another reason for the spirited debate is that the millions of dollars generated annually by the user fee act have become so crucial that neither side can afford for it to expire.

``The user fee legislation has created the proverbial scorpions in the bottle," said William W. Vodra , a former FDA lawyer and now a partner at the law firm Arnold & Porter . ``If the legislation is not renewed, then it has catastrophic consequences for both the FDA and the industry. So, the question then becomes who is going to blink first?"

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