changes at fda but not in priorities, says henney
December 18, 1998
Marketletter via NewsEdge Corporation : Jane Henney's priority as US Food and Drug Administration Commissioner is the full and effective implementation of the FDA Modernization Act, she told the annual meeting of the US Food and Drug Law Institute last week, just one day after taking the oath of office.
While noting that it was too early for her to make policy pronouncements or predictions, Dr Henney told the meeting that it was good to be "recalled. " The FDA is much different to when she was last there in 1994, and some of its processes have changes as a result of FDAMA and RE-GO (reinventing government), she noted, but this has not changed agency priorities.
Need For FDA Leadership To "Stay Focused" Managerial experience in public health organizations is her forte, but being FDA Commissioner is about leadership. It will be for her and for the top FDA leadership to stay focused on what is important, she noted, especially implementing FDAMA, in both its spirit and letter. The agency has made remarkable progress in doing that, without additional resources and while doing its regular work, she noted, and agreed with the FDAMA directive to be in touch with agency stakeholders, as listening to this input will maximize agency effectiveness. This dialogue needs to be ongoing, she added.
While the agency has been directed under FDAMA to identify where it is not meeting its statutory obligations, and how to correct the situation, she said that she is committed to the congruence between the law, policy and outcomes but will not hesitate to point out where this cannot be done. Dr Henney also stressed her commitment to strengthening the agency's science base, which must guide critical policy decisions and reviews. The science base is also important for field staff, she said; the agency must pay attention to recruiting and retaining top personnel, and leveraging scientific expertise at other government institutions and in academia. The FDA must have the scientific knowledge to keep up with the complex products being developed as a result of huge investments in basic research within other branches of government and in industry, she said.
Other priorities include focus on administration initiatives on food safety, blood supply and tobacco regulation.
With the ongoing budget constraints imposed on the FDA, she said, it is important to keep priorities in mind. Quoting from a speech she made to the FDLI as an FDA representative seven years ago, she said the FDA still faces challenges, still lives in difficult times and still needs to find innovative solutions to problems. It needs to re-examine itself constantly and to redefine its efforts to meet its goals, she said, while never missing a chance to evolve to meeting those goals.
Any New Waxman-Hatch Law "Will Be Fair" It is unclear if Congress will develop a new version of the 1984 Waxman-Hatch legislation, Orrin Hatch told the meeting, but he pledged that any action will be fair. Sen Hatch also pledged to work with Judiciary Committee chairman James Jeffords, during upcoming hearings on the issue, to assure fairness.
Pointing to the huge monetary investment by both government and industry, he said there is a need for incentives and protections for that research as well as an assurance that the medications developed as a result of this research will be affordable. He also expressed confidence that FDA Commissioner Henney will treat the dietary supplement industry fairly, and hoped for a new attitude at the agency regarding these products.
Noting that consumer use of dietary supplements has skyrocketed, he said that consumers do not understand the legal differences between pharmaceuticals and dietary supplements, but assume that supplements are safe and effective and that they come under the same scrutiny as pharmaceuticals. While pointing out that most dietary supplements are safe and effective, he encouraged consumers and industry to work with the FDA to solve any problems.
He was also hopeful that Dr Henney will not push innovative new products with compelling science, such as Benecol, into the drug box or tie these products up in other ways for years so that consumers cannot benefit from them.
Agency Is "Seriously Underfunded," Says Hatch Among his priorities for the agency are the securing of adequate resources to accomplish all that it must; the FDA is seriously underfunded, he said, and volunteered to be an advocate for needed resources. It also needs adequate facilities and space, he added.
Recruitment and retention of a highly-skilled workforce is also important, he commented, and with the departure of several top employees from the FDA, it will be the task of Commissioner Henney to put in place a top leadership team. He particularly praised the work of outgoing head of the Office of Regulatory Affairs Ron Chesmore, FDA Deputy Commissioner Michael Friedman and outgoing Deputy Commissioner Bill Schultz.
The FDA is one of the most important, if not the most important, agency within the government, said Sen Hatch, and all must be assured that scientific facts and the law are driving decisions at the agency. Call the shots the way you see them, he advised Dr Henney, and stakeholders should support FDA decisions even if they do not like them.
Sen Hatch pledged to be both the agency's best friend and severest critic, commenting that while there is much good about the FDA, there is also much that can be improved.
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