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Congress tries to wrap up approval process

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FILED IN:  Applications  > Healthcare  > Pharmaceutical

Starting in August 1998 drug manufacturers in a "priority" category will have to include new "geriatric use" subsections in the packaging inserts destined for physicians and pharmacists. That same requirement will go into effect for six other categories of drugs on a staggered schedule between 1999 and 2003. That timetable was laid out in a final rule from the Food and Drug Administration published in August. Although it was a final rule the FDA asked for industry comments on whether the data the companies would have to sift through to determine whether their products are affected would create a burden under the Paperwork Reduction Act of 1995. Based on those responses the FDA could theoretically alter some aspects of the rule. But that is not expected. That's because the FDA gives the companies a number of options to avoid making wholesale changes to its insert. For example a company can simply make a declaration that a drug product was not tested on people over the age of 65 during the clinical trials done to win that drug's approval from the FDA. If that is the case the company can easily include a simple prescribed FDA statement in its packaging insert. Some drugs such as those for birth control won't even have to include that boiler plate statement. The Geriatric Use subsection would include information on the numbers of people over age 65 and over age 75 who participated in clinical trials and the differences on how those groups were affected. A longer discussion of those differences must then be included in the other sections in the package insert such as those on "Contraindications" "Warnings" and "Dosage and Administration." The priority group the first to whom the new requirements apply includes psychotropic drugs nonsteroidal anti-inflammatories digoxin antiarrhythmics and calcium channel blockers oral hypoglycemics anticoagulants and quinolones. The remaining six groups were formed based on the date a drug's license was approved by the FDA. Those with licenses issued since 1989 must include a geriatric subsection by August 1999. Older drugs have later start dates for compliance. John Siegfried M.D. director of scientific and regulatory affairs for PhRMA the drug industry trade group says his members have known for three years that this rule was coming down the pike. He doesn't expect the upcoming deadlines for geriatric use subsections to create too much havoc. c

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