FDA Faces New Pressure to Speed Approval Process

Nancy Sullivan, a fictional character who stars in a radio advertising campaign, is a 31-year-old woman with breast cancer who desperately needs a drug that is available overseas but not in the United States because the Food and Drug Administration is still determining whether it is safe and whether it works.

“Those of us who are sick don’t have time for this,” Sullivan says. “Someone needs to give [the FDA] a wake-up call, and that wake-up call has got to come from the U.S. Congress.”

The ad, paid for by Citizens for a Sound Economy, a nonprofit public policy group, is just one of a host of emotional pleas that is flooding the airwaves as Congress prepares to take up legislation aimed at accelerating FDA procedures for approving drugs and medical devices.

The bill’s fate could rest on whether the public is willing to believe the ads, which strike at the heart of many Americans’ deepest fears: coming down with a critical illness and being unable to get the drug that might cure it.

The ads are catchy--but are they truthful? FDA officials and their supporters call them deceptive because they ignore all the good that the FDA has done by keeping superficially appealing but potentially dangerous products off the market.

“The FDA’s fundamental political problem is that its successes are invisible,” said Donald Kettl, a University of Wisconsin professor of public policy. “There are things that people never hear about. All you have to do is look at the collection of things that could go wrong--and do go wrong--and you could see what would happen if there were no FDA, or a weakened FDA. But it’s very hard for the FDA to make that case.”

That is because federal law prohibits the FDA, as a government agency, from lobbying for public support.

“We can’t buy ad time,” said a senior agency official who requested anonymity. “That would be an inappropriate use of government money. . . . We can’t fight paid media with paid media.”

The FDA is allowed, however, to round up expert testimony, reports and statistics arguing that the agency has streamlined its approval process in recent years--but that to quicken the pace further would compromise public safety.

For example, it circulated two recent studies by the General Accounting Office, a congressional watchdog agency, on Europe’s new system of drug approval. FDA critics have pointed to the European system as a model of efficiency. The GAO concluded that it is too early to make such a judgment.

Dry and legalistic GAO reports, however, are no match for ads such as one sponsored by the Competitive Enterprise Institute, a public-policy group dedicated to limiting the reach of government regulation.

Its radio ad features a man who is allowed to drown while his would-be rescuers look on helplessly, unable to throw him a rope because government inspectors have not finished reviewing the paperwork describing the rope’s safety and effectiveness.

This is equivalent to what is happening as the FDA drags its heels, according to the ad, on allowing the sale of potentially life-saving drugs.

“If FDA approves a therapy that will start saving lives tomorrow,” intones the voice on the radio, “then how many people died yesterday waiting for FDA to act?”

Many of the nonprofit organizations behind the anti-FDA campaign receive funding from industries likely to benefit from a speedup of FDA functions, such as drug and medical device companies, although the groups deny that their positions are influenced by money.

“We do get industry money, of course,” said Greg Smith of the Competitive Enterprise Institute. “Most people don’t give us money just because they think we’re neat. But the bulk of our money doesn’t come from industries, it comes from foundations.”

Some FDA officials, speaking privately, have suggested that the campaign against the agency--and Republican lawmakers’ eagerness to go after it--are the result of opposition to their attempts to regulate tobacco as a drug.

But Lydia Verheggen, director of health policy for Citizens for a Sound Economy, insisted that the tobacco issue was only an indirect factor.

“It’s a distraction from the FDA’s core mission,” she said. “Why are they taking on tobacco when they can’t even get their regular job done? This agency touches everybody’s lives and it’s broken. It’s up to Congress to fix it.”

In past years, the FDA was criticized not for being too slow to approve new drugs but for being too cozy with the drug industry.

Before current Commissioner David A. Kessler’s tenure, the agency was shaken by allegations that FDA reviewers received clandestine industry payments in exchange for quick approval of generic drugs.

The FDA’s authority has been enhanced over the years in the wake of disasters affecting thousands of people. Medical devices, for example, were subjected to FDA regulation only in 1976, after the Dalkon Shield intrauterine device caused infertility and other problems for thousands of American women.

Nevertheless, the Republican-dominated Congress is expected to take up the issue of FDA reform when lawmakers return this week from their spring break.

The legislation now percolating in Congress would scale back the FDA’s authority. The Senate Labor and Human Resources Committee has sent a bill to the Senate floor and some House members have begun drafting a similar measure.

Prospects for the legislation are uncertain. Even if Congress should agree on a formula for reining in the FDA--and previous such efforts have failed--President Clinton is regarded as likely to veto it.

Kessler, a Republican first appointed by then-President Bush and reappointed by Clinton, has insisted that the agency and congressional reformers share the same goals. Lawmakers, he has said, are operating under an outdated perception of the agency’s performance.

“Unfortunately, too many of our critics justify the call for ‘reform’ based on how the FDA did its job in the 1980s or earlier,” Kessler said in recent testimony before the Senate Labor and Human Resources Committee.

“They have missed the substantial progress . . . that the FDA [has] achieved over the past several years,” he continued. “Those who fail to recognize the agency’s performance and achievements threaten . . . to undermine the real progress the agency has made.”

In 1987, Kessler said, it took the FDA an average of 33 months to act on applications for approval of new drugs. By 1992, the FDA had trimmed the average time to 19 months. And recently, the FDA, by allowing drugs for critical illnesses to reach the market before studies are complete, has reduced the review period to a matter of weeks for some AIDS drugs.

Moreover, the FDA has been able to beef up its own review staff with resources derived from user fees imposed on pharmaceutical manufacturers. Congress mandated the user fees in 1992 legislation that also required the agency to shorten its review periods to 12 months for standard drugs and six months for breakthrough drugs.

FDA officials have sought similar user-fee legislation for medical device review but Congress has not acted.

The Senate measure, which awaits full Senate action, would further reduce the drug review deadlines to six months and four months, respectively. Kessler calls those periods unrealistic and potentially dangerous.

“I do not believe the agency could meet the product review times . . . without compromising existing public health protection,” he said in Senate testimony.

To meet those deadlines, he said, manufacturers would have to submit perfect applications, requiring no clarification or new information. They would also need to be ready to manufacture the drug immediately, because the FDA would have to start pre-approval factory inspections at the same time it began reviewing the drug itself.

In addition, Kessler said, such tight deadlines would require the FDA staff to be “ready to work on the application the day it comes in the door.” That would mean putting other work on hold.

When the Senate committee drafted its bill, senators approved an amendment that would allow manufacturers of new medical devices to choose a private company, rather than the FDA, to review the safety and effectiveness of their products. The manufacturers would have to pay the cost of the review.

The FDA recently started its own program, but only for low-risk medical devices. An FDA insider who asked not to be named said that he was appalled by the Senate provision, which, he said, would allow manufacturers to “buy an approval.”

Finally, perhaps in an expression of how some Republican lawmakers personally feel about Kessler’s performance, the Senate committee also approved limiting the FDA commissioner’s term to five years.