The US Food and Drug Administration will never have sufficient resources to be “the quality-control unit of the world,” and drugmakers will have to assume more responsibility for the quality of their products, a senior agency official has told US legislators.
The FDA is not the industry’s quality system, and the agency is holding companies accountable, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, warned after addressing a hearing convened on April 24 by Democratic Senator Edward Kennedy, chairman of the Senate Education, Labor, Health and Pensions (HELP) Committee to discuss the contaminated heparin supply. “Any legislative fixes that do not address quality by design will fail,” she added.
Dr Woodcock told the panel that much of the USA’s pharmaceutical process has moved overseas in the last 15 years, with finished medicines then being imported back into the country, and that elements of generic drugs can be produced in as many as 15 different facilities. The FDA of “the last century” is not constructed to regulate the volume of medicines and foods which are now produced abroad, she said, adding that while the agency’s responsibilities have soared, inspection resources have dropped.
Sen Kennedy agreed with Dr Woodcock that the agency needs increased funding for inspections and also called on drugmakers to improve their testing for contamination and impurities. “Even the most up-to-date manufacturing processes won’t ensure safety if manufacturers can’t guarantee the ingredients aren’t contaminated,” he said.
However, Senator Mike Enzi, the Ranking (Republican) Committee member, pointed out that more inspections by FDA officials would not have discovered the contaminated heparin and that increased funding would not guarantee the safety of imports. The reality of the global economy is that testing every food and drug product from outside the USA is not currently possible, “nor will it ever be,” he said.
– On April 21, the FDA reported that 11 countries – Australia, Canada, China, Denmark, France, Germany, Italy, Japan, The Netherlands, New Zealand and the USA – have found contaminated heparin within their boundaries. Sen Kennedy responded that there is now “no excuse for delay. Congress and the Administration must work with the FDA to keep Americans safe from these tainted drugs. At a time when the American people are being asked to provide yet more billions for Iraq, we must make certain that the resources are found to address challenges at home,” he said.
