WASHINGTON _ Multi-lateral negotiations betweenU.S. and overseas drug regulators continue to makeprogress to standardize and streamline requirements ondrug manufacturers.

Elaine Esber, associate director for medical and internalaffairs with the FDA's Center for Biologics Evaluationand Research, told a recent meeting of the Food and DrugLaw Institute (FDLI) that negotiations between FDAofficials and their European and Asian counterparts areproducing consensus agreements.

Esber spoke at the FDLI conference just two days afterreturning from a conference on trade harmonization heldin Brussels.

Esber said the FDA soon will publish in the FederalRegister several additional consensus agreements thathave been developed by the International Conference onHarmonization (ICH), the administrative structure that ischarged with enabling drug manufacturers to do businessin the global marketplace with few redundancies inregulation.

In order to minimize the number of duplicative clinicalstudies and data submissions that drug manufacturersmust complete to meet each country's requirements,consensus agreements have been crafted by ICHparticipants. Now near the final stage of development arestatements on genotoxicity tests and good clinicalpractices that investigators must adhere to.

The consensus documents are the product of the ICHSteering Committee, a group of 250 representatives fromthe U.S., U.K., European Economic Community, Canada,Mexico, India, Japan, Egypt and a number of othercountries, who meet three times a year in an effort tomove forward discussions on areas of agreement.

The steering committee deliberates in working groups ondiscrete issues such as quality, safety and efficacy, Esbertold the FDLI conference.

The ICH facilitates harmonization of regulatoryrequirements between and among governments as well asthe World Health Organization, said Esber. "There's lotsof information sharing on a government to governmentbasis and well with officials from the WHO," she said.

ICH's next meeting with be held in November inYokohama, Japan.

U.S. drug regulators have ongoing tri-partite talks withthe U.K. and Canada. These talks have added significancethis year as U.S. lawmakers look to the European modelto reform the U.S. drug regulatory apparatus. SeveralCongressional staff members are currently studying theattributes of European drug regulation, according toStephan Lawton, an attorney with the Washington lawfirm of Hogan & Hartson who drafted the BiotechnologyIndustry Organization's (BIO's) reform plan.

FDA officials also are involved in talks with NorthAmerican Free Trade Agreement (NAFTA) tradingpartners. Bi-lateral talks are also taking place with theEuropean Economic Community, Mexico and Canada,said Esber. Less formalized talks are underway with Indiaand Egypt.

Not so far along in the consensus process but still slatedfor public comments are consensus documents on drugtoxicity on male fertility; analysis of the expression ofconstruct of cells used for the production of r-DNAderived protein products; stability testing of biotechproducts; structure and content of clinical study reports;and the conditions under which drugs must be subjectedto carcinogenicity studies.

Some 17 other documents are in the draft stages and notyet available for public review, according to Esber.

Within the past 12 months the FDA has published 10documents in the Federal Register that are the directresult of the harmonization efforts. These agreementsinvolved several broad issues as well as considerationsfor specific populations. For example, on March 1 theFDA published six consensus statements, including theassessment of systemic exposure in toxicity studies anddose selection for carcinogenicity studies ofpharmaceuticals. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.