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New leadership for the FDA
EDITORIAL
THE LANCET Volume 360, Number 9341
New leadership for the FDA The US Food and Drug Administration (FDA) looks likely to have finally found a new Commissioner; Mark McClellan, a 39-year-old physician-economist who, as a member of the President’s Council of Economic Advisors, has been one of President Bush’s top aides on health policy. The new job is likely to be a very tough one. The FDA not only regulates all prescription and non-prescription drugs marketed in the USA, but also all medical devices, blood products, vaccines, tissues used for transplantation, all animal feed and drugs, cosmetics, and 75% of food (everthing except meat and poultry). Commissioner McClellan will thus have regulatory authority over products which account for roughly one-quarter of all US consumer spending. The behind-the-scenes fight over who would be chosen to lead the agency left the post vacant for nearly 2 years. Industry groups, particularly those representing pharmaceutical companies, lobbied the Bush Administration to pick a Commissioner who was sympathetic to complaints by drug companies that the agency’s drug approval policies remain unduly rigid and deny patients access to important new treatments. According to press reports, several highly qualified candidates were dropped from consideration by the Administration because of objections from the pharmaceutical industry that they were not sufficiently industry-friendly. However, Senator Edward Kennedy, the Democratic chairman of the Senate Health, Education, Labor, and Pensions Committee, was likely to block the nomination of any candidate with strong industry ties. McClellan thus seems to be a compromise candidate: he is well known and respected by members of both political parties. One of the main challenges the new Commissioner is going to have to face is how to continue to reduce the time it takes for a new drug to obtain FDA approval, without endangering patients. In 1992, Congress passed a law called the Prescription Drug User Fee Act (PDUFA), which authorised the agency to collect fees from pharmaceutical companies to pay for the review of the drugs they wanted to bring to market. In return for these funds, the FDA was mandated to meet performance goals guaranteeing timely reviews. Since implementation of the Act, THE LANCET • Vol 360 • October 19, 2002 • www.thelancet.com
review times have indeed fallen but critics of the measure argue that industry funding has created a conflict of interest for the FDA, which has led to lax oversight and the approval of dangerous drugs of questionable value. These drugs, the critics charge, have proven to have marginal benefit but substantial side-effects, leading to scores of patients being injured or killed. A report released last month by the US General Accounting Office, an investigative agency of the US Congress, suggests the results of PDUFA have indeed been mixed. The report entitled, “Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activites” (www.gao.gov, accessed Oct 15, 2002) concludes that the fees have allowed the FDA to make new drugs available more quickly. From 1993 to 2001, approval times for standard drugs have dropped by nearly half, from a median of 27 months to 14 months. Approval for new drugs has dropped more than two thirds, from 21 months to about 6 months. At the same time, there has been a rise in the percentage of drugs that have had to be withdrawn from the market after approval because of safety-related reasons; from 3·10%, in the 8-year period before PDUFA’s implementation, to 3·47% in the 8 years following the act’s implementation. FDA officials disagree with this analysis but not with another finding of GAO investigators: that in order to meet its performance goals the agency has had to markedly increase reviewers’ workload, leaving staff little time for training and development. The demands, in fact, may be leading the agency’s highly trained experts to leave, often for higher paying industry jobs. As a result, the FDA has staff turnover rates among its scientists far higher than that seen among scientists working at other agencies, such as the Centers for Disease Control or the National Institutes of Health. Clearly, one of of the first jobs facing the new commissioner is to move to restore morale at the agency. This means convincing Congress not only to supply the agency with the budget it needs to retain its staff, but also to restore its independence from industry funding. The Lancet 1183
For personal use. Only reproduce with permission from The Lancet Publishing Group.
THE LANCET Volume 360, Number 9341
New leadership for the FDA The US Food and Drug Administration (FDA) looks likely to have finally found a new Commissioner; Mark McClellan, a 39-year-old physician-economist who, as a member of the President’s Council of Economic Advisors, has been one of President Bush’s top aides on health policy. The new job is likely to be a very tough one. The FDA not only regulates all prescription and non-prescription drugs marketed in the USA, but also all medical devices, blood products, vaccines, tissues used for transplantation, all animal feed and drugs, cosmetics, and 75% of food (everthing except meat and poultry). Commissioner McClellan will thus have regulatory authority over products which account for roughly one-quarter of all US consumer spending. The behind-the-scenes fight over who would be chosen to lead the agency left the post vacant for nearly 2 years. Industry groups, particularly those representing pharmaceutical companies, lobbied the Bush Administration to pick a Commissioner who was sympathetic to complaints by drug companies that the agency’s drug approval policies remain unduly rigid and deny patients access to important new treatments. According to press reports, several highly qualified candidates were dropped from consideration by the Administration because of objections from the pharmaceutical industry that they were not sufficiently industry-friendly. However, Senator Edward Kennedy, the Democratic chairman of the Senate Health, Education, Labor, and Pensions Committee, was likely to block the nomination of any candidate with strong industry ties. McClellan thus seems to be a compromise candidate: he is well known and respected by members of both political parties. One of the main challenges the new Commissioner is going to have to face is how to continue to reduce the time it takes for a new drug to obtain FDA approval, without endangering patients. In 1992, Congress passed a law called the Prescription Drug User Fee Act (PDUFA), which authorised the agency to collect fees from pharmaceutical companies to pay for the review of the drugs they wanted to bring to market. In return for these funds, the FDA was mandated to meet performance goals guaranteeing timely reviews. Since implementation of the Act, THE LANCET • Vol 360 • October 19, 2002 • www.thelancet.com
review times have indeed fallen but critics of the measure argue that industry funding has created a conflict of interest for the FDA, which has led to lax oversight and the approval of dangerous drugs of questionable value. These drugs, the critics charge, have proven to have marginal benefit but substantial side-effects, leading to scores of patients being injured or killed. A report released last month by the US General Accounting Office, an investigative agency of the US Congress, suggests the results of PDUFA have indeed been mixed. The report entitled, “Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activites” (www.gao.gov, accessed Oct 15, 2002) concludes that the fees have allowed the FDA to make new drugs available more quickly. From 1993 to 2001, approval times for standard drugs have dropped by nearly half, from a median of 27 months to 14 months. Approval for new drugs has dropped more than two thirds, from 21 months to about 6 months. At the same time, there has been a rise in the percentage of drugs that have had to be withdrawn from the market after approval because of safety-related reasons; from 3·10%, in the 8-year period before PDUFA’s implementation, to 3·47% in the 8 years following the act’s implementation. FDA officials disagree with this analysis but not with another finding of GAO investigators: that in order to meet its performance goals the agency has had to markedly increase reviewers’ workload, leaving staff little time for training and development. The demands, in fact, may be leading the agency’s highly trained experts to leave, often for higher paying industry jobs. As a result, the FDA has staff turnover rates among its scientists far higher than that seen among scientists working at other agencies, such as the Centers for Disease Control or the National Institutes of Health. Clearly, one of of the first jobs facing the new commissioner is to move to restore morale at the agency. This means convincing Congress not only to supply the agency with the budget it needs to retain its staff, but also to restore its independence from industry funding. The Lancet 1183
For personal use. Only reproduce with permission from The Lancet Publishing Group.