U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Conversation with Stakeholders
Temple University School of Pharmacy
Philadelphia, April 28, 1999
Center Directors Report
Center Director Janet Woodcock, M.D., opened the session by reviewing the state of drug regulation and CDERs current level of performance for the 96 attendees. She reported that CDERs core programs, especially in the area of premarket review, are performing efficiently and effectively. She referred the audience to statistical information contained in the CDER 1998 Report to the Nation: Improving Public Health Through Human Drugs (http://www.fda.gov/cder/reports/rptntn98.pdf). User fees have resulted in more new drug approvals with the peak in 1996. She noted that approvals for new uses of existing drugs have doubled in the last three years compared with the previous three years, indicating that firms are continuing to conduct studies on drugs once they are marketed. The generic drug program helps improve the affordability of medicines through competition. This program area does not receive support from user fees; but, through streamlining processes, it has reduced approval times from three and a half years to 18 months.
Dr. Woodcock also reviewed the Centers performance in the post-market surveillance programs for prescription drug advertising and promotion, adverse events involving drugs and product quality. Efforts at international harmonization are an important step to setting up a worldwide safety system. Consumers can be assured that drug product quality is very high in United States.
In the area of drug safety, she rejected the notion that shorter approval times have compromised review standards and led to an increase in drug withdrawals. There is evidence that CDER currently performs a higher quality review than previously when it was accused of taking too long to review drugs. For example, the number of patients studied has grown, drug recalls are down, and withdrawals are fewer than in previous decades. In other areas, she reported on the transition to an electronic review environment, noting that the equivalent of 12 million pages of paper were submitted last year electronically. One area for improvement is making better use of regulatory research. The Center met its deadlines related to the FDA Modernization Act of 1997.
Paul G. King, Ph.D., a consultant, expressed his views on FDA inspections of current good manufacturing (CGMP) practices. He disagreed with current FDA practices and called for strict enforcement of all CGMP regulations, continual training of FDA inspectors and batch release testing.
Lorna Totman, Ph.D., director of scientific affairs, Consumer Healthcare Products Association, pointed to the "remarkable success story" of switching about 80 drugs from prescription only sales to over-the-counter sales. The law doesnt say how FDA should make the decision if a drug can be sold over the counter. Consequently, each decision is made on a case-by case-basis, with the FDA demanding more complex data to justify each switch. She called for the Center to identify in advance the kinds of high quality safety studies needed to switch a drugs status. For example, she said that CDERs guidance on hypercholesterolemia effectively blocks OTC switches of cholesterol-lowering drugs. She called on the Center to amend its guidance by identifying specific questions that could be investigated scientifically and would provide evidence for safely switching cholesterol-lowering drugs to OTC status. She encouraged joint workshops with associations and industry with the goal of addressing current problems. Jointly developed meetings help FDA benefit from scientific expertise in industry.
CDER/FDA Panel Discussion
Ways to improve communications about the risks and benefits of drugs were the top issues raised during the audience participation portion. Issues were discussed by a CDER/FDA panel consisting of Dr. Woodcock; Susan Setterberg, Mid-Atlantic Regional Director; Douglas Ellsworth, New Jersey District Director; and Nancy Smith, Ph.D., Director, CDER Office of Training and Communications (OTCOM). Linda Brophy, OTCOM Associate Director, moderated the question and answer session. Issues raised in open discussion included the pros and cons of direct-to-consumer advertising, improving communications for consumers and health care professions about the risks and benefits of drug therapy, and setting priorities for the FDAs limited inspection resources that most effectively meet public health and safety needs.
Last update: July 13, 2005