WASHINGTON _ The FDA has reiterated its policy onissuing holds on clinical trials. The agency contends, inthe Aug. 23, 1995 Federal Register, that these decisionsare clearly supported by scientific evidence and notimposed capriciously.
But the drug industry isn't so sure and has includedprovisions in its FDA reform legislation that wouldrestrict the agency's ability to issue clinical holds.
A clinical hold is the FDA's primary mechanism forprotecting subjects involved in clinical trails. A clinicalhold may be placed on one or more of the investigationscovered by an investigational new drug application. Oncea study is on clinical hold, subjects may not be given theinvestigational drug and no new subjects may be recruitedto an ongoing study. Patients already in the study areprevented from receiving additional therapy involving theinvestigational drug unless permitted by the FDA.
The Pharmaceutical Research Manufacturers of America(PhRMA) and the Biotechnology Industry Organization(BIO) have agreed in their bilateral FDA reform bill thatthe agency should be required to make a "morecompelling case" when issuing a clinical hold, saidPhRMA spokesman Steve Berchem. "Too many timesmanufacturers have been told that the `FDA hasconcerns', and have never gotten specifics," he said in aninterview with BioWorld Today.
To require that a clinical hold decision be made only atthe highest levels of the FDA, the PhRMA-BIO bill alsocalls for a clinical hold decision to be made by an FDAoffice director, midway between a center director anddivision director.
To reduce what PhRMA calls the agency's "propensityfor informal holds," the industry bill would require thatthe clinical hold be in effect for five days after whichFDA officials would have to lift the hold or justifycontinuing it, said Berchem.
FDA policy now requires that the director of the divisionresponsible for reviewing the drug application isresponsible for issuing the clinical hold. In addition, theFDA waits 30 days before it gives the sponsor a writtenbasis for the clinical hold.
The agency said that if deficiencies in a clinical trial arefound, the agency will hold informal discussions toresolve the matter with the study sponsor. If that attemptfails, a clinical hold may be ordered.
The FDA said the industry's concerns are beingadequately addressed through a committee establishedmore than five years ago within the agency's Center forDrug Evaluation and Research (CDER) that is chargedwith reviewing "selected clinical holds for scientific andprocedural quality," according to the Federal Registernotice.
Despite the re-affirmation of its policy, the FDA noticeannounced that it was entertaining requests from drugcompanies for a committee review of any clinical holdplaced during the past 12 months. Committee procedurespermit a manufacturer who does not wish to have formalreconsideration of a pending clinical hold to have thathold considered anonymously. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.