CDRH BiMo audits lead to surge in warning letters.

Device manufacturers will have to exercise more oversight of their clinical research in the coming years due to an upswing in warning and Auntitled@ letters by the Cen-ter for Devices= Bioresearch Monitoring (BiMo) program.

A similar jump is expected for drugs, especially among sponsor monitors. Earlier this year, Dr. Bette Barton, M.D., chief of the Clinical Investigations Branch

of the Center for Drugs= Division of Scientific Investiga-tions, said in an interview that a sponsor survey was under way in anticipation of beefed up audits in this area (See March 2 issue, page 1).

Figures on drug-related BiMo warning letters,

which were unavailable as of deadline, will be covered

in an upcoming issue.

A major factor in why FDA is homing in more on sponsor/monitors and IRBs is that the Inspector General of the Department of Health and Human Services criti-cized the way the agency and National Institutes of Health enforce rules regarding subjects= rights.

In May, the I.G. issued an audit report that was unveiled at a House Government Reform and Oversight subcommittee hearing (Doc. 108227R).

CDRH BiMo

Warning and Untitled Letters

Fiscal 1998 vs. Fiscal 1997

Warning Letters Untitled Letters

In addition, there is some thought that incoming FDA Commissioner Dr. Jane Henney, M.D., will do for BiMo what her predecessor Dr. David Kessler, M.D., did for pre-approval and bulk inspections and enforcement of promotion and labeling rules.

In the device area, the number of warning letters jumped significantly for sponsor monitors and for a new category B promotion and advertising.

These statistics show that the Center for Devices BiMo program is going after manufacturers more and more. (Continued Next Page)

BiMo division director Charma Konnor said in an interview: AWe are inspecting more sponsors than we have in the past. I would relate [the increase] to more enforcement.@ Konnor herself participated in an audit

of Abbott Labs in July and August B an inspection that yielded a significant warning letter (see page 4).

She said the huge increase in promotion and advertising BiMo letters is due to Acompanies ratting

on each other,@ meaning that FDA is following up on complaints from firms about promotion and advertising

of investigational devices for unintended uses.

Konnor also said FDA is getting leads from ex-employees finking on their former employers.

On Oct. 27, Konnor told the Regulatory Affairs Professionals Society (RAPS) annual meeting in Washington that the top three most common deficien-cies found with sponsor/monitors were inadequate study monitoring, inadequate device accountability and inad-equate record keeping.

She said the use of untitled letters has been help-ful to get clinical investigators and IRBs to be aware of FDA regulations, which is why warning letters are lim-ited for the researchers and non-existent for IRBs. Konnor said the I.G.=s report on IRB enforcement is

not affecting CDRH compliance efforts.

In April, FDA initiated a new regulatory letter B the NIDPOE, or Notice of Initiation of Disqualification Proceedings and Opportunity to Explain. The agency=s intent was to encourage uniformity among the centers in their communications with clinical investigators, since CDER almost never issues warning letters to investiga-tors, while CDRH has no qualms about doing so (see April 13 issue, page 1).

However, CDRH still has not issued a NIDPOE letter. CDER, on the other hand, has issued Aseveral,@ a source said.

Sincerely,

The Editors