WASHINGTON _ The FDA is changing safety reportingrequirements for drugs and biologics in pre- and post-marketingphases and those new regulations will be available for comment latethis summer.Murray Lumpkin, acting director of the Center for Drug Evaluationand Research at the FDA made the announcement at Monday'sPharmaceutical Update '94, a program sponsored by the Food andDrug Law Institute.The new reporting rules will address several matters of particularconcern to biotech companies, Lumpkin told BioWorld. One is theeffort to make consistent both data and adverse drug reactionreporting in the U.S. with the requirements of the InternationalConference on Harmonization (ICH), a group of industry andregulatory bodies from the U.S., Europe and Japan. The ICH's goalis to harmonize pharmaceutical development guidelines for clinicaland animal testing and manufacturing. It operates under theauspices of the International Federation of PharmaceuticalManufacturers Associations in Geneva."One of our problems is when we start talking about data tocounterpart agencies in other countries, we're not talking about thesame data," said Lumpkin. "We cut it our way, Europe cuts it theirway."As for adverse events, the different requirements in differentcountries create a lot of extra work for companies that sell drugsabroad, Lumpkin said. For example, the U.S. Code of FederalRegulations requires reporting of fatal or life-threatening adversedrug reactions within three working days, while other countrieshave other time requirements. The ICH requires reporting withinseven calendar days.Also of major concern are regulations for clinical trials that wereproposed in the wake of the fialuridine trials that resulted in thedeaths of five people last year.These would require that protocols specify that adverse clinical orlaboratory findings should be reported to the sponsor immediately_ even if the findings could be attributed to underlying disease orother drugs.Researchers would be compelled to estimate the number of deathsand serious side effects to expect during each trial. And in thecourse of pre-market trials, side effects would have to be evaluatedtwice yearly, instead of once.Also, the FDA's MEDWatch system for reporting adverse reactionsto commercial drugs, biologics and devices would be adopted as theprimary adverse event reporting system. MEDWatch was designedto make it easy for doctors to report adverse events to the FDA, andfor the agency to get these reports into the hands of themanufacturers. The FDA consolidated six different event-reportingforms into a single two-sided form which doctors use for any drug,biologic or device. FDA Commissioner David A. Kessler unveiledMEDWatch in June 1993.

-- David Holzman Special To BioWorld Today

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