Bioterrorism bill includes provision renewing drug user-fee law

While it is becoming increasingly unlikely that Congress this year will approve compromise legislation providing prescription drug benefits to Medicare recipients, a lower-profile piece of multibillion-dollar drug legislation is flying through with little public scrutiny.

Back in 1992, Congress passed the Prescription Drug User Fee Act, which allows the pharmaceutical industry to pay the Food and Drug Administration to review industry products more quickly. The idea was born out of a unique collaboration between AIDS activists, then-FDA Commissioner David Kessler, the drug industry, and Congress. In 1997, Congress renewed the law after vigorous debate and numerous hearings.

Now, through a series of secret meetings and behind-the-scenes negotiations, key lawmakers have again renewed and updated the law and quietly added it in conference committee-without much notice by the media or the public-to a high-profile $3 billion bill to battle bioterrorism.

The pharmaceutical industry was heavily involved in the latest reauthorization of the drug user-fee act, which occurred largely outside of Congress's "regular order." No committee markups were held on the issue, and neither the House nor the Senate approved its own legislation before the recent action in the bioterrorism conference committee, which wrapped up its work on May 21.

In March, the House Energy and Commerce Committee, chaired by Rep. W.J. "Billy" Tauzin, R-La., held the only congressional hearing during the 107th Congress on the drug user-fee legislation. Sen. Edward Kennedy, D-Mass., the chairman of the Senate Health, Education, Labor, and Pensions Committee, did not have a hearing-much to the consternation of consumer groups-for fear that the bill would become bogged down by extraneous amendments, congressional aides said.

"Senator Kennedy came to the conclusion that the bioterrorism conference report, which involved many of the stakeholders in the [drug user-fee] debate, was an excellent vehicle," said Kennedy spokesman Jim Manley.

Asked about criticisms over the way the drug user-fee act was reauthorized, spokesmen for Kennedy and Tauzin, the lead negotiators, have said they wanted a "clean bill." But a clean bill may be in the eye of the beholder.

By most accounts, the drug user-fee act, which was due to expire on September 30, has been a major success for the industry, patients, and the overburdened FDA. At the hearing by an Energy and Commerce subcommittee in March, Tauzin boasted of the program's success by citing statistics showing that about half of all new drugs are first made available in the United States, and 80 percent of all new drugs are available to American patients within a year of approval. The law "is working and must be renewed," Tauzin said.

During the 1980s, drug review times at the FDA lagged far behind those of its European counterparts, and patients and the industry demanded that more be done to get breakthrough products onto the market. In 1992, as the federal budget tightened and it became clear that major new government funding would not be forthcoming, Congress approved the proposal in which the drug industry would pay the FDA a set fee to move new drug applications through the review process more quickly.

"The drug approval process became much more efficient," said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents most large U.S. drugmakers. "Patients started receiving medicines faster."

Drug review times have plummeted since the act was first implemented. FDA data shows that in the late 1980s, it took the agency about 30 months to approve a regular new drug. In recent years, the median time has fallen to about 15 months.

The FDA also says that priority drugs-those singled out for their potential effect on life-threatening diseases-are getting to market more quickly. The median approval time for priority new drug and biotechnology applications dropped from 13 months in fiscal 1993 to only six months in fiscal 2000. Acting FDA Commissioner Lester Crawford told the Energy and Commerce Committee in March that he expects the rate to stay at that level.

The drug industry, which is a major booster of the user-fee concept, worked out the recent refinements to the law during a series of private meetings with FDA officials. Lawmakers included the refinements suggested by the FDA and the industry in the bioterrorism conference report virtually unchanged. The House approved the conference report on May 22, and Senate passage appeared likely by week's end or soon after the Memorial Day recess.

The user-fee process has meant big savings for the pharmaceutical industry, about $1.2 billion annually, according to FDA estimates. Over the next five years, the industry is expected to pay the agency a total of $1.2 billion in user fees.

But patient and consumer groups, including some that initially pushed for the creation of the user-fee program, are having second thoughts. Public Citizen contends that the program has led to an undue emphasis on speedy drug reviews at the expense of drug safety and other components of the FDA's core mission to protect public health.

"Our concern has been that the user-fee program may have undermined the integrity of the FDA's drug review process," said Ben Peck, legislative representative for Public Citizen's Congress Watch.

The group has published a series of reports suggesting that since the first user-fee law was enacted in 1992, the FDA has had to withdraw more dangerous drugs from the market. "Despite the unprecedented removal from the market for safety reasons of nine drugs approved from 1993 through 2000, not one committee with jurisdiction over the FDA has held a single oversight hearing," Public Citizen said in a report in February. FDA officials respond that the drug withdrawal figures are increasing proportionately with the increases in new drug approvals.

Another interest group, the Patient and Consumer Coalition, contends that the user-fee process does not allow for adequate input from consumers and patients. "Consumers are the ones that pay for and use the medical products, and therefore have a vital stake in the safety and effectiveness of the nation's drugs," the coalition said in a recent briefing paper.

Through the recent hush-hush deliberations, the FDA insisted on making some changes to the user-fee law. For instance, the reauthorization legislation includes a provision allowing the FDA to direct user-fee money to monitoring the safety of new drug products after they reach the market.

Initially, the industry was reluctant to have its user fees go toward anything but drug approval. "This represents a little bit of a paradigm shift here," said Alan Goldhammer, the vice president for regulatory affairs at PhRMA, who formerly worked for the Biotechnology Industry Organization, the trade association of the major biotechnology firms. "One of the concerns was that the program was no longer a fee-for-service program; rather it would end up being a tax on the industry."

Eventually, the FDA and the industry reached an agreement, which they forwarded to Congress in March. The agreement allows the agency, in certain cases, to direct user fees to specific drug-safety programs for two or three years after drug approvals.

Drug-safety advocates say that the compromise does not go far enough, and they complain about the closed process under which the legislation was developed. Rep. Sherrod Brown, D-Ohio, the ranking member of the House Energy and Commerce Health Subcommittee, had pushed strongly to give the FDA broad authority to direct user-fee money toward general drug-safety programs, not just the ones the industry approves. Brown also wanted to devote more funding to FDA regulation of drug advertising.

"The public really needs to believe that, ultimately, the FDA is in their corner," said Ted Miller, a spokesman for Brown. Miller added that House Democrats were less than thrilled with the way the user-fee law was reauthorized. "We have to work within the process that is under way," he acknowledged.

The connection between user-fee money and drug safety may also pose conflicts of interest at the FDA between drug-application reviewers and drug-safety officers. "Under the current system, the post-marketing [drug-safety] folks were kind of separated from the environment of approvals," said Public Citizen's Peck. "Now they won't be. Our concern is they will develop a vested interest in the approval."

Rather than relying so heavily on industry fees, Peck suggests that the FDA should receive more funds through the regular congressional appropriations process. Congress is "willing to put money into the [National Institutes of Health] for new cures," he said. "It doesn't seem to make sense not to put money into drug safety." Peck added: "It's a very bad process for the FDA to go to industry every five years and say: What do you want?"

Industry officials bristle at such comments. "Critics of the industry have been given ample time to get in their shots," said Trewhitt of PhRMA. He noted that the drug user-fee agreement has been available for public review since March.

Meanwhile, the user-fee program for drug approvals inspired manufacturers of medical devices to develop their own user-fee program. They pushed, albeit unsuccessfully, to have their proposal attached to the bioterrorism conference report as well.

The proposal for a user-fee program for FDA review of medical-device applications would have required $150 million in industry user fees and $75 million in new congressional appropriations over the next five years. According to Steve Ubl, a lobbyist for AdvaMed, the medical-device industry's trade association, the FDA's device review program has been "facing the perfect storm of declining resources and a flat budget over the past 10 years." Ubl added: "On the other hand, they've faced a rising tide of innovation, more applications, and more-complex applications."

Kennedy this week raised the prospect that his committee will act on the proposal separately this year. Not all medical-device companies are happy with the plan, however. Although the proposal makes some provisions for smaller companies, the trade association that represents many smaller companies believes that the process may have set a bad precedent.

"The process is being done in a way that may not protect small manufacturers," said Larry Holden of the Medical Device Manufacturers Association, who was not directly involved in the negotiations. "It does harm the policy of user fees by negotiating it behind closed doors."

April Fulton is a reporter for National Journal's CongressDaily.