Medical Device Daily Washington Editor

If new FDA chief Andrew von Eschenbach concludes that his job is a lot like being drawn and quartered, even the casual observer might empathize.

The agency most recently is being lambasted for being too quick to approve drugs and devices seen most obviously in the flack it receives concerning the approval of Vioxx and emerging negative data tracking drug-eluting stents and it now must listen to the old refrain, heard most often in the '80s and '90s, that it isn't working quickly enough.

The Competitive Enterprise Institute (CEI; Washington) held a conference call yesterday to go over the results of its survey of 175 orthopedic surgeons from across the country, that poll seeking their impressions of the agency's approach to device and drug approvals.

Coming as no great surprise, the agency did not fare particularly well.

CEI said that the survey notes a consistency with its previous polls concerning the agency and it cited "an exceptionally negative view of FDA." In particular, it found that 76% of respondents think that the FDA is too slow to clear drugs and devices, and 73% believe that these delays hurt patients.

Seven of 10 respondents also voted in favor of allowing "access to unapproved therapies if they carry a warning about their unapproved status."

The renewed surge of opinion that the agency needs to work faster mirrors, and could come to exceed, a similar groundswell of criticism common in the years leading to the passage of the Food and Drug Modernization Act of 1997, with critics of the agency mostly from industry repeatedly complaining of slow review times and refusal to permit valuable new therapies into the market. (Did the imposition of user fees quiet those criticisms for a time, since faster agency action would likely result in calls from the agency for higher fees?)

Additionally, the notion of bypassing the FDA review mechanism, by allowing broader use of unapproved products, has now become a larger part of the discussion, thanks in part to the Washington Legal Foundation (Washington) and the Abigail Alliance for Better Access to Developmental Drugs (Fredericksburg, Virginia), which have been pushing this idea.

The CEI survey found that "orthopedic surgeons who had been in practice eight years or less consistently stood out as most critical of FDA's approval process," which may be the result of a greater awareness of recent technological developments by this group.

And about 73% said that the lag time at the agency "hurts patients by forcing them to go without potentially beneficial new therapies."

Sam Kazman, the CEI's general counsel, confirmed that up to 1997, "there was a growing recognition that there was a problem with FDA's approach." But he said that the greatest danger now is that "the wave of attacks on FDA for what is really a handful of questionable approvals" could cripple and further slow approval processes.

Concerning the too-fast-vs.-too-slow dilemma, Kazman remarked: "Just because a drug is available does not mean it has to be used. But if it's not available, nobody can use it."

Acknowledging the dangers of broad use of unapproved drugs and devices primarily a legal backlash Kazman emphasized that the physician would be obliged to tell the patient that the drug or device is unapproved and ethically bound to offer a solid explanation as to why it might be more effective than therapies that have cleared the FDA gauntlet.

On the other hand, he noted that if unapproved drugs and devices are more commonly employed, doctors may end up "being found guilty of not using the best possible treatment."

Kazman admitted that any move to circumvent the FDA approval process would require a public education component, given the perception that risk aversion is very much on the minds of Americans.

But, he asked rhetorically: "What is risk?"

While a bad drug or device makes it into distribution with the result that people suffer or even die delays also incur suffering, he noted. In this latter case, he said, "the agency stays out of trouble, invisible journalistically and politically" because those losses are not immediately apparent.

Kazman said that Congress may be in the best position to make the case to the public for broader use of unapproved devices and drugs.

"The challenge now for politicians is to make it clear that there are two sides to this coin," he said. "If your aim is to have zero unexpected side effects, you have to have zero therapies, which in our view would be a disaster."

Kazman noted that CEI has conducted similar polls for more than a decade and that the previous polls targeted specialties such as oncology, "not only because they're part of mainstream medicine, but also because they gave treatments of a life-or-death nature."

The decision to approach orthopedic surgeons for the current survey, he said, was prompted by emerging demographic trends and the need to focus more specifically on quality-of-life issues. Thus, joint replacement, arthritis and osteoporosis are "of increasing importance in the world we live in," he said, an obvious allusion to the Baby Boomer generation and the general greying of the U.S. population.

As for Vioxx, 80% of the respondents to the CEI survey indicated that they are in favor of Merck (Whitehouse Station, New Jersey) bringing its COX-2 inhibitor back on the market despite any liability concerns.

An FDA advisory panel has recommended that Merck reintroduce the drug, but the company steadfastly refuses to do so, even in the face of the impending lapse of patents for three products that combine for 22% of its sales volume.

Its position is undoubtedly reinforced by the specter of lawsuits in connection with allegations that its osteoporosis treatment, Fosamax, destroys bone tissue in the jaw. The company has put more than $900 million into its defense account for Vioxx and another $48 million for possible Fosamax suits.

An analysis of the survey indicates that more than 21,000 orthopedists are in practice in the U.S. and that the survey carried a margin of error of 7.4%.

"The vast majority (81%) of orthopedic surgeons operate private practices and, on average, perform 32 procedures per month," a statement concerning the survey said.