Commentary Magazine


Posts For: June 19, 2007

Taking the FDA Global

The Food and Drug Administration, created in 1906, has been one of the most successful regulators in history—carrying out the monumentally complicated task of keeping America’s pantries and medicine cabinets free of harmful products even as the food and drug businesses have grown exponentially more complex. But as the drug business in particular has gone global in the past few decades, the FDA’s job has moved from extremely difficult to well-nigh impossible. Unless, of course, it can make some radical changes.

The drug business has been an international market for a very long time. Until recently, this has just meant that many of the most familiar drugs in your pharmacy have come from France or Switzerland—countries whose regulators work closely with the FDA. No one really worries about the quality of imported Canadian or European drugs, and the FDA is well positioned to inspect and certify those drugs.

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The Food and Drug Administration, created in 1906, has been one of the most successful regulators in history—carrying out the monumentally complicated task of keeping America’s pantries and medicine cabinets free of harmful products even as the food and drug businesses have grown exponentially more complex. But as the drug business in particular has gone global in the past few decades, the FDA’s job has moved from extremely difficult to well-nigh impossible. Unless, of course, it can make some radical changes.

The drug business has been an international market for a very long time. Until recently, this has just meant that many of the most familiar drugs in your pharmacy have come from France or Switzerland—countries whose regulators work closely with the FDA. No one really worries about the quality of imported Canadian or European drugs, and the FDA is well positioned to inspect and certify those drugs.

But as the Washington Post reported on Sunday, the Euro-American character of the drug industry is rapidly changing. India has become a major pharmaceutical power, and China is increasingly a source of ingredients and chemicals used by drug companies worldwide. As the Post notes:

In 1999, India did not appear on an FDA chart of master files [applications to sell pharmaceutical ingredients in the U.S.]. By 2004, almost half of the reviewed files for drug ingredients destined for U.S. patients came from Indian companies. More recently, Indian companies have moved more aggressively into making finished drugs, and Chinese companies—which expect as many as 4,000 international buyers at a series of drug ingredient conferences in Shanghai this month—have expanded their share of the market in active ingredients.

The FDA is supposed to inspect foreign sites that produce significant amounts of food or drugs sold in America. But there are very few inspectors in India and China, and for the most part the FDA relies on each nation’s internal quality control measures.

So far, there has not been a major safety scare with drugs from India or China; these problems, for the moment, lie under our consumer radar. But given long enough our luck will run out. The pet food scandal earlier this year, which involved ingredients from China, offered a tiny hint of what a major international drug scare would look like. It would reveal the thin strands of our drug safety net, and the extremes to which the FDA is now being stretched.

The drug industry looks nothing like it did in the year of the FDA’s birth. The time has come for the agency to change as well. It is simultaneously too stringent in reviewing domestic drug development and too lax in assuring the basic safety of drugs and ingredients imported from abroad. The former problem could be addressed by a greater focus on the post-approval testing of new drugs, while the latter would benefit from much more oversight of the countries that are becoming the main suppliers of our drugs and drug ingredients. The agency needs to return to its founding mission as a guarantor of essential safety and efficacy, which means doing both far more and far less than it does now.

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Teaching Soldiers

It seems fairly certain that the Army will expand over the next few years. The only question is by how much. Secretary of Defense Robert Gates wants to increase it from 510,000 soldiers to 547,000. Many of the presidential candidates, both Republican and Democratic, are calling for even bigger increases. Tom Donnelly of the American Enterprise Institute argues persuasively in the Weekly Standard that we should aim for a force of 750,000, which would represent a return to the level at the end of the cold war.

These calls for expansion are necessary. But an important secondary issue, and one not discussed publicly as much as it should be, is what to do with all these extra troops. Donnelly lays out a wide variety of missions that the U.S. armed forces need to carry out around the world. Unfortunately, as we are learning in Afghanistan and Iraq, today’s military is still not well-prepared for the challenges of a post-9/11 world. But now one of the Army’s most innovative thinkers, Lieutenant Colonel John Nagl, has come forward with a simple but brilliant idea for one step that his service should take to reshape itself: create a standing Advisor Corps of 20,000 soldiers for the training of foreign military services.

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It seems fairly certain that the Army will expand over the next few years. The only question is by how much. Secretary of Defense Robert Gates wants to increase it from 510,000 soldiers to 547,000. Many of the presidential candidates, both Republican and Democratic, are calling for even bigger increases. Tom Donnelly of the American Enterprise Institute argues persuasively in the Weekly Standard that we should aim for a force of 750,000, which would represent a return to the level at the end of the cold war.

These calls for expansion are necessary. But an important secondary issue, and one not discussed publicly as much as it should be, is what to do with all these extra troops. Donnelly lays out a wide variety of missions that the U.S. armed forces need to carry out around the world. Unfortunately, as we are learning in Afghanistan and Iraq, today’s military is still not well-prepared for the challenges of a post-9/11 world. But now one of the Army’s most innovative thinkers, Lieutenant Colonel John Nagl, has come forward with a simple but brilliant idea for one step that his service should take to reshape itself: create a standing Advisor Corps of 20,000 soldiers for the training of foreign military services.

Nagl’s views deserve to be taken very seriously. Not only is he a combat veteran of Operation Desert Storm and Operation Iraqi Freedom, he is a contributor to the new U.S. Army/Marine Corps Counterinsurgency Field Manual and the author of an influential study of counterinsurgency, Learning to Eat Soup with a Knife: Counterinsurgency Lessons from Malaya and Vietnam. Nagl also commands a battalion at Fort Riley, Kansas, that trains teams to educate and advise security forces in Iraq and Afghanistan.

Though the Army has made advances in how it sets up such training teams, Nagl points out that the soldiers who “train the trainers” don’t, for the most part, have much real-world experience in training foreign militaries. Nagl’s proposed Advisor Corps is a remedy to this problem. “This corps,” he writes, “would develop doctrine and oversee the training and deployment of 750 advisory teams of 25 soldiers each.” Soldiers would rotate through assignments in this Corps just as they currently rotate through the 10th Mountain Division or the 101st Airborne Division. In an ideal world, their advisory service would count as much as service in a “line” unit when it comes to promotion.

Creating such a Corps would enable us to make the kind of long-term commitment to Afghanistan and Iraq necessary to achieve a modicum of stability and democracy. As things stand now, the Army is straining to produce a few thousand embedded advisors—far too few for the challenges ahead.

Adopting Nagl’s idea would make more sense than simply creating more infantry or armor brigades focused on “kinetic” action. We need those too, of course. But we also need different kinds of competencies within our armed forces—and the government at large—if we are to prevail in the long war we now face.

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Bush’s Worst Blunder?

George W. Bush has made his share of serious mistakes. Back in April, I noted here that one of the worst, to my mind, was awarding America’s highest honor, the Presidential Medal of Freedom, to his CIA director George Tenet, a holdover from the Clinton administration, who presided over a series of critical intelligence failures and let the country down.

But I wrote that before I had completed reading Tenet’s own account of his directorship, and I explicitly reserved the right to change my mind. Now that I have finished his memoir and written an article about it for the July-August Commentary, has my assessment changed?

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George W. Bush has made his share of serious mistakes. Back in April, I noted here that one of the worst, to my mind, was awarding America’s highest honor, the Presidential Medal of Freedom, to his CIA director George Tenet, a holdover from the Clinton administration, who presided over a series of critical intelligence failures and let the country down.

But I wrote that before I had completed reading Tenet’s own account of his directorship, and I explicitly reserved the right to change my mind. Now that I have finished his memoir and written an article about it for the July-August Commentary, has my assessment changed?

The answer is: yes and no. Tenet himself discusses the medal in his book and is disarmingly self-deprecating. When he was informed by Brett Kavanaugh, a presidential assistant, that President Bush wanted to honor him with the Medal of Freedom, he writes that:

I was not at all sure I wanted to accept. We had not found weapons of mass destruction and postwar Iraq hadn’t been the cakewalk that some had suggested it would be.

I asked Kavanaugh why the President wanted to honor me, and to read the proposed citation. It was all about the CIA’s work against terrorism, not Iraq. Fair enough, I thought. Perhaps I could accept a medal on that basis, not for me so much as for the agency.

But if Tenet had mixed feelings accepting the award, what prompted President Bush to bestow it on him in the first place? Was it because Tenet had named the CIA’s headquarters in Langley, Virginia, after Bush’s father, or was it a way—a successful way—to hedge in advance against criticism from Tenet? The answer is still unclear

Far more central than the medal issue is whether, after deciding to keep Tenet in his administration in January 2001, Bush should have fired him on September 11. My own view, given the catastrophe that had just taken place and given all the CIA fiascos that were to follow, is that by September 12, that action was overdue.

But there is another side of the coin. We had just been attacked massively on our own soil. Within the U.S. government there was a widespread conviction that a second wave of terrorism, possibly with weapons of mass destruction, was on the way. This was not a propitious moment to reshuffle the deck in a frontline counterterrorism agency.

And even with hindsight there is another reason why it is less than clear that firing Tenet might not have made a significant difference in the way things turned out. After all, when Tenet finally did step down, Bush’s replacement, Porter Goss, was also profoundly flawed, with key members of his management team caught up in tawdry scandal, and he was rapidly chewed up by the bureaucracy.

One of the lessons that one takes away from all this is that fixing the CIA is not a simple matter of changing its leadership. It is true that a fish rots from the head. But if one cuts off the head of a stinking fish, the rot does not go away.

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