Washington Editor

WASHINGTON - The path is clearing for Andrew von Eschenbach to lead the FDA as its commissioner on a full-time basis. Recent news on resolving an over-the-counter application for the Plan B contraceptive product, which has held up his Senate confirmation process thus far, should help usher him to the post.

For many who watch the agency, particularly those in the drug development industry, that's a good thing.

Over the last five years, the FDA has had a Senate-confirmed commissioner for only 18 months, and that revolving door has coincided with an eroding confidence in the agency's ability to fulfill its charter of regulating the safety and efficacy of health care products. In addition to widely reported risks with a number of popular prescription drugs, there have been charges of politics trumping science in regulatory decisions. As a result, the role has been described as a hot seat.

But a strong leader would have the ability to reverse the negative image at the FDA.

Former FDA official Amit Sachdev, who now works as the Biotechnology Industry Organization's executive vice president for health, said that Senate approval provides "clear authority" for a commissioner "to lay out and execute a broader vision for transforming the agency." The Washington-based trade organization supports von Eschenbach's nomination, and sooner rather than later.

Having him at the helm would be a boost to the industry for a couple of reasons. One biotech company executive told BioWorld Today that effective guidance from the top filters directly down to the culture around drug reviewers, and effective management can ensure that the recent heightened safety concerns at FDA don't supersede a product's therapeutic efficacy. Fewer FDA approvals per year and a retooling of its post-approval oversight have been feared by drug companies and some patient advocacy groups in the two years since the market withdrawal of the painkiller Vioxx.

From a budget perspective, a confirmed leader would have the "power and ability to effectively work for good base appropriations" at the FDA, Sachdev said, which could turn around funding problems faced by the agency's drug-review teams, and thus decrease a reliance on user fees. Those industry-generated funds "were never intended to supplant" congressional appropriations, Sachdev added.

Still, that's exactly what has happened. A glance at FDA spending since the Prescription Drug User Fee Act became law reveals that user fees have become a crutch. In 1993, PDUFA fees covered 7 percent of drug review costs, while these days the fees account for 53 percent of the same costs. However, the duration of reviews has flat lined of late - standard reviews have taken about 12 months, on average, between 1998 and last year, and priority reviews have averaged a little more than six months - even though PDUFA fees have nearly doubled, from about $125 million to $250 million in that same seven-year time frame.

While PDUFA fees have increased, congressionally appropriated funds available for drug review have decreased, and drug companies have not been happy with that outcome. Paying for new tasks related to biodefense, pandemic preparedness and other matters beyond the FDA's original focus is important, but doing so by reassigning drug review money hasn't been the right answer.

"There has not been significant growth in [funding] the core mission and core base appropriation for the FDA," Sachdev said, "and a confirmed commissioner can really help deliver those types of results."

Discussions on PDUFA's next iteration remain ongoing, partly to ensure that the user fee program is not an outright "deficit-reduction mechanism when there are reductions in base appropriations," he added. Representatives from the FDA, BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA) are operating in concert to finalize the bill's language ahead of next year's expiration of the third version of PDUFA.

An approved leader also benefits FDA personnel, its "primary asset," Sachdev said. Already, 60 percent of its overall budget is tabbed for staff salaries and benefits, he said, and that grows to 80 percent when including regulatory affairs personnel. Von Eschenbach's confirmation, he said, would "provide both leadership and direction to the staff in a way that encourages and enhances morale." Internal dissatisfaction has been on the increase, according to independent polls, though they contrast FDA-conducted surveys.

Also, congressional approval could prove a boon for the public and private investors on whom the biotech industry heavily relies. Sachdev said stable, predictable leadership at the agency "helps foster" a steady regulatory climate, "and that's got to provide some comfort to the markets."

Along similar lines, an industry executive told BioWorld Today that companies and patient groups view confirmation as a step toward ensuring that today's initiatives and guidances to speed the drug development process are here to stay.

Action on von Eschenbach's nomination could come next month, when congressional members reconvene following this month's recess, if President Bush doesn't appoint him beforehand. A hearing by the Senate Health, Education, Labor and Pensions Committee was held just before the break, and Chairman Mike Enzi (R-Wyo.) has indicated that there is enough support to advance the nomination through the committee process. But beyond that, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) would have to lift their procedural block to permit a vote by the full chamber.

That could happen if indeed the agency settles the Plan B contraceptive controversy.