FDA: Planning for the Next Century
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ELIZABETH FARNSWORTH: The Food & Drug Administration was created in 1906 when conditions in the meatpacking industry spurred Congress and President Theodore Roosevelt to pass the Pure Food & Drug Act. It was the nation’s first major piece of consumer protection legislation. Today, all drugs, cosmetics, and medical devices, and most foods must be approved by the FDA before they can be marketed to the American public. The agency’s standards for approval are the strictest in the world but the FDA has also long been at the center of a national debate over how far the government should go to protect consumers. Last week, the Senate Labor & Human Resource Committee considered a bill that would force the agency to approve new drugs and devices faster.
SEN. NANCY KASSEBAUM, (R) Kansas: There still is an enormous amount of time and effort that takes place i bringing new drugs and devices to the market. I think it has proven that it’s not only complex and time-consuming but costly. Adding the time for FDA review and approval, it now takes an average of 12 years and about $350 million to bring a new drug to the marketplace.
ELIZABETH FARNSWORTH: The bill, sponsored by Committee Chairman Kassebaum, would require the FDA to act within four months on applications for new drugs to treat life-threatening diseases or other illnesses with no approved treatment, require action within six months on all other applications, require the agency to meet the new drug approval deadlines by 1998 or contract out parts of the approval process to private companies, and products could be sold on the market if the FDA missed the deadline but the products had been approved by authorities in the United Kingdom or European Union. A 1992 law had already set deadlines for the agency to shorten its review times. FDA Commissioner David Kessler, citing a General Accounting Office report, testified his agency is ahead of schedule in meeting those deadlines and is already reforming itself.
DR. DAVID KESSLER, Commissioner, FDA: Those who fail to recognize the agency’s performance and achievements in 1996 threaten, intentionally or not, to undermine the real progress that has been made. The agency’s progress has been independently reviewed by the GAO and determined to be substantial. GAO looked at the new drug applications submitted between 1987 and 1992 and found that the average time it took to review and approve NDA’s dropped dramatically from 33 months to 19 months. GAO also found that we are faster than the United Kingdom.
ELIZABETH FARNSWORTH: To demonstrate the complexity of the approval process Committee Republicans displayed 200,000 pages of documents a pharmaceutical company claimed to have used in its application to the FDA.
SEN. DAN COATS, (R) Indiana: Aren’t things supposed to happen without our constant vigilance and oversight and screaming and hauling books in here? Why is that not taking place at FDA, or why hasn’t it before? Maybe with our pressure it has taken place. And then I began to think, well, maybe it’s not just bureaucracy, maybe it’s not just mismanagement, maybe it’s a mind set. Maybe it’s a mind set that says, you know, you really can’t trust those companies. I wonder if there isn’t a Ralph Nader mentality, mind set, out at FDA, that basically allows people to start with a bias against approval, a bias against companies seeking to expedite a process, trying to get a new drug.
ELIZABETH FARNSWORTH: Kessler warned against the consequences of taking deregulation too far.
DR. DAVID KESSLER: I think the major cultural change that’s taken place, and I believe in, is that we’re willing to take risks, especially when patients can benefit. I think that is absolutely key. We are approving some drugs in very short time frames, and one day, Senator, we’re going to make a mistake. But that’s okay. I mean, everybody wants everything today, but if something goes wrong, I’m going to be sitting here and answering the question: Where was FDA?
ELIZABETH FARNSWORTH: Today it was a House Commerce Subcommittee’s turn to hold hearings on revamping the FDA. Members have not yet drafted a bill, but they are exploring alternatives that would go further than the Senate bill, including allowing private companies and researchers to review some new medicines which would reduce the FDA’s rule to simply certifying the approval process.