The FDA: Part 1

The Food and Drug Administration (FDA) not only neglects American health care but prevents breakthrough drugs from reaching the market. It is an industrial barricade, with patients on one side and pharmaceutical companies on the other. The FDA discourages research and development by putting pharmaceutical companies through an exhausting drug approval process, a system that is iniquitous and sometimes even fraudulent. Heightened regulation and extended clinical testing delay new drugs from entering the market, so much that the average time for FDA approval nearly doubled from 8.1 years in the 1960s to 15.2 years by the 1990s.

Expenditures have also doubled, much due to indirect costs aroused by wayward FDA procedures. Pharmaceutical companies currently spend $800 million to introduce a new drug to the market, which multiplies as Congress further expands FDA authority. Moreover, less than one-third of all FDA-approved drugs recover their development costs. The FDA condemns progress and censors the production of lifesaving medications. You don’t have to sympathize with pharmaceutical companies to understand why this is a problem. FDA authority has increased so much that in 2002-04 a whopping 58 new drugs received FDA approval, a 47 percent decline since the 1996-98 period.

FDA reviewers are trained to be risk-averse, so much that FDA Commissioner Alexander Schmidt admitted, “In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of the FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them.” Strict regulatory oversight intimidates reviewers in their approval of new drugs, delaying or refusing altogether, drugs that reduce pain and save lives. With an overwhelming bureaucracy that dictates behavior, Schmidt asserted, “the message to FDA staff could not be clearer.”

Henry Miller worked 15 years for the FDA and served as a founding director of the FDA’s Office of Biotechnology. Now he is one of the FDA’s most vocal critics. Miller’s frustration with bureaucracy, and the political red tape that prolong drug approvals, gave him much distaste for the organization. Following his resignation, he expressed his discontent: “In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed. The trends are ominous: The length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for more than a decade.” Miller observed FDA politics firsthand, and watched idly while corruption shielded the public from drugs that could potentially save thousands of lives.

The FDA has a fatal track record. In August 2007, the D.C. Circuit Court of Appeals reversed a previous ruling that restricted a patient’s right to take investigational, FDA-unapproved drugs. The leukemia drug Gleevac passed its first phase of testing in 1998—ruling that it was both safe and effective—and when physicians requested the drug for treatment in June 2001, the FDA denied their request. The clinical trials display the success Gleevac has had on leukemia patients: 80 percent of the test subjects are still alive today. Despite conclusive evidence, Gleevac did not gain approval until March 2003, after 3,600 patients had been denied the drug, many of which died in waiting.

The FDA has delayed many other cancer drugs, leaving thousands of cancer victims to die every year. Ronald Trowbridge and Steven Walker report the FDA’s deadly pattern in the Wall Street Journal:

"The American Cancer Society reports that some 550,000 cancer patients die annually, making the number of cancer deaths from 1997 to 2005 about 4.8 million. Over that same period, the FDA reports granting individual access to an investigational drug to not more than 650 people per year for all diseases and drugs—a pathetic, even cruel, pittance. A few thousand more patients managed to gain access by enrolling in relatively small clinical trials or exceedingly rare expanded access programs."