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National Review Online


Wanted: Leadership at the FDA

March 02, 2004

By David Gratzer

Having nominated Dr. Mark McClellan to run the Centers for Medicare and Medicaid Services, President Bush has a job opening at the Food and Drug Administration. With civil unrest in Iraq and economic unease at home, the Bush White House is unlikely to fret seriously about the need to fill an administrative position in a regulatory agency. Indeed, there may be a temptation to let such an uninspiring housekeeping-matter wait until after the election or beyond. But if the White House is serious about America's health and the future of medicine, it had better find an excellent replacement for Dr. McClellan—and fast.

The FDA is an organization whose work falls largely off the public's radar. As a result, some may assume that its role is less than crucial. But the FDA oversees the regulation of roughly 25 cents of every dollar spent by consumers. This major role includes the approval of all new pharmaceutical and biotech drugs and genetically modified foods. The FDA, in other words, has an impact on what's in your fridge and in your medicine cabinet.

The trouble is, the FDA may be the most risk-adverse agency in America. Dr. Henry Miller, a senior fellow at Stanford's Hoover Institute (and occasional contributor to NRO) who served at the FDA for 15 years, tells a story of its bureaucratic malaise. Dr. Miller was on the group that reviewed the first biotech application. The drug, insulin, was manufactured using gene-splicing techniques (previously, insulin had literally come from the pancreases of cows and pigs, an expensive and slow process). After four months of deliberation, and armed with reams of data on efficacy and safety, Dr. Miller's team was prepared to go ahead. Since drug approval averaged two and a half years, his supervisor hedged, reasoning that: "If anything goes wrong, think how bad it will look that we approved the drug so quickly." (Dr. Miller waited until his supervisor went on vacation and then got approval from his supervisor's boss.)

Of course, the story isn't new. Since the insulin approval, the FDA has gone through four commissioners, and as many acting commissioners. But the same problems remain. Consider Erbitux. For two years, the FDA procrastinated on approval, arguing that it lacked adequate data for this anti-cancer drug. Finally, this month, the FDA gave the green light—acting, incidentally, on the same basic data set previously deemed inadequate.

ImClone, the maker of Erbitux, has been in the news because household maven Martha Stewart may have sold company shares using insider information, thereby saving herself some $50,000. But thousands of patients with advanced colon cancer haven't had the chance to benefit from this effective drug while the FDA hedged on approval. Which is the real scandal?

And there are other examples. Despite the positive recommendation of an expert panel on silicone implants, the FDA balked at approval. Again, it seems to be a case of good public relations winning out over good patient protection.

Dr. McClellan worked hard to address these deficiencies. A physician and economist, he brought a unique background to the FDA's top job. Recognizing the sluggishness of drug approval, he took important, if modest steps: a focus on clinical endpoints and tighter timelines. He also spoke out on major issues, such as drug reimportation and price controls. Clearly, the White House has appreciated his efforts, enough to want to put him in charge of the difficult task of implementing a Medicare drug benefit.

But the White House shouldn't neglect the FDA. Dr. McClellan had the courage to observe that the agency was in disarray; a new commissioner must work to clean up the mess. After all, the future of medicine is in the balance.

Erbitux was a visible and clear example of the FDA's sloth. But there is a more subtle issue: The cancer-drug pipeline is hardly robust. Vanderbilt University researchers recently concluded that there was a 68 percent reduction in new drug approvals during 1999-2004 than over the preceding five-year period. The bigger pharmaceutical picture isn't much brighter. Despite billions in new research spending, in fact, the number of drug approvals has barely budged since the 1970s.

Part of the problem is the FDA's excessive regulations. Since 1964, the total time required for drug development, from synthesis of the molecule to marketing approval, has more than doubled, now topping 15 years. And it's not just the incredible delay that's problematic: Drug companies, according to the Tufts Center for the Study of Drug Development, spend almost $900 million to bring a drug to market. Thirty years ago, the cost was a mere $138 million (adjusted for inflation). The bureaucratic hurdles, in other words, have been set too high.

FDA caution is undermining our ability to make new drugs and save lives. President Bush has shown leadership on numerous issues. Now, he needs to ensure quality drugs for the patients of today and tomorrow. He can do this quickly and easily. Annoy the bureaucrats, Mr. President, and fill the FDA vacancy with a reformer.

Original Source:



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