|
Related sites |
New group aims to speed drug approvals
Posted
11-29-99 Alexandria, Va. A new private organization will combine the efforts of the Food and Drug Administration (FDA), the pharmaceutical industry, and academia to speed drug approvals and reduce the costs of pharmaceutical development. The Product Quality Research Institute will work to reduce the regulatory burden on companies seeking FDA approval by conducting research on the drug manufacturing process-research that up until now has been costly for the FDA. "The research dollars needed we don't have anymore," said Ajaz Hussain, PhD, director of the division of product quality research for the FDA. The institute will have no responsibility for clinical research. The institute will be overseen by the American Association of Pharmaceutical Scientists (AAPS) and will be a nonprofit, tax-exempt corporation. Funding will come from contributions by the pharmaceutical industry. "We think this will result in a reduced regulatory burden by defining how we can back off without adversely effecting the outcomes," said Larry Augsburger, PhD, AAPS president and professor of pharmaceutical science at the University of Maryland School of Pharmacy. "The consumers will benefit, too. If there is less costly testing involved and more efficient processes, ultimately there will be cost savings that ought to be passed on to the consumer. It will also create faster tracking of products through the regulatory process." Consumer groups are concerned about moving the public process to the private sector. "This is one more step in the privatization of the Food and Drug Administration," said Larry Sasich, PharmD, MPH, research analyst for Public Citizen. "This takes a research function from inside the FDA to outside the FDA, and that is somewhat distressing." Officials stress that the FDA won't be giving up control over the regulatory process. "FDA policies still rest solely with the FDA," Hussain said. The institute "only provides research data. Nothing has changed with giving up some of the functions to the outside." The institute has eight founding member organizations: the AAPS, the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, the National Pharmaceutical Association, the Consumer Healthcare Products Association, the Parenteral Drug Association, the Pharmaceutical Research and Manufacturers of America, and the FDA Center for Drug Evaluation and Research.
|