A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office.

Mansour has been perplexed, he reports, at the non-approvable letter that Schering Plough received recently. Its sugammadex is a genuinely novel therapy. (It reverses the effects of muscle relaxants used in anesthesia.) The FDA’s advisory committee voted to approve the drug unanimously. Then FDA said: “No.” As is its perogative.

There is no support group of sugammadex patients petitioning editorial pages. Bloggers are not up in arms about sugammadex being unavailable in recovery rooms. No Hollywood stars or rappers are coming to its defense.

Holding Pattern

What’s up? Mansour says that a pre-election FDA is girding itself for new management in the nation’s capitol, and is less interested in something that doesn’t cure cancer or heart disease. Higher-profile therapies, he says, are getting more attention. There’s a desire to have no decision that a new president or his aides would want to reopen.

“It would seem they could have approved this if they had wanted to,” Mansour says of the FDA. “It probably falls into a category of drugs they’re not willing to go out on a limb for. The politics are different than they used to be.”

FDA officials, he proposes, are hunkering down. ‘“They are concentrating their political capital on life-saving therapies, things that will get them positive recognition from the House and Senate, Waxman and Durbin and others,” says Mansour.

Black Box

Even so, he confesses a bit of frustration and bafflement at why the FDA made its decision. Thousands of pages of regulation and statute, a respectable Rolodex—none of it can really shed light on the agency’s thought process. Was there a scientific rationale? Presumably the FDA had ... doubts. “The decision-making process is really something we’re not privy to,” he says. “What is the genesis of those questions? Is it genuine concern? How is it that the Europeans are satisfied with the information, even with their precautionary nature, whereas our officials aren’t?”

Mansour makes it clear he has no knowledge of what motivation may underlie the FDA’s sugammadex decision. But the larger context is years of congressional criticism. We confessed to Mansour that we didn’t think it mattered if a shy, publicity-averse politician from the corn belt attacked the industry, simply because such attacks never become law.

Mansour disagreed. He thinks the cumulative weight of the criticism of the FDA has been internalized, and caused it to be more risk-averse. “They are developing an internal hierarchy of decisions,” Mansour says. “Those are largely a function of the political realities and the things that have happened in the past.” As in Vioxx.

Mansour says that once the political climate has moderated, there is a need for a more substantive discussion about how to improve the relative speed and efficiency of the U.S. regulatory process. “There are people sitting up on Capitol Hill and other places saying our drug approval process is unwieldy and takes forever,” he says. “Why not start focusing on making the process more efficient?”

In The Vise

It has not escaped Mansour’s attention that the FDA is under siege from two directions: industry types who believe it is too stringent and activist groups who believe it is weak. As he puts it, “They’re being hammered from both directions.”

Mansour doesn’t believe that significant increases in the FDA budget, especially after the FDAAA legislation last year, will have much affect. New funds will quickly be exhausted by genotyping tomatoes in Mexico or inspecting slaughterhouses in China. “There is always more to spend it on. They’re in a bind,” says Mansour.

New Management

Under more normal political circumstances, Mansour says, some sponsors feel so strongly about a rejected drug that they go over the heads of the FDA officials and petition their bosses at the U.S. Department of Health and Human Services (HHS). But that high-risk strategy is a no-go, he says, simply because everything is locked down. “That’s not going to work right now,” notes Mansour.

Mansour supposes that a Democratic administration would probably lean heavily on recommendations from Senators Edward Kennedy and Richard Durbin. And if the Republicans hold the White House? “It’s not realistic to assume McCain will be a friend to industry,” Mansour says. “Industry will have to find a way to work with either administration.”