FDA inspections attacked in hard-hitting editorial by Biomedical Market Newsletter.

COSTA MESA, Calif.--(BUSINESS WIRE)--Nov. 28, 1994--Biomedical Market Newsletter, Inc. Monday released a hard-hitting editorial attacking the U.S. Food & Drug Administration (FDA). In BMN's November issue, the publisher attacks the legality of new FDA on-site inspections of medical manufacturing facilities nationwide. BMN is a monthly, international, 24-page business, regulatory, marketing and financial medical trade newsletter.

The hard-hitting editorial, an exclusive authored by noted industry authority David G. Anast, MPA, publisher of BMN, as well as accompanying articles, provide new details and raise disturbing questions about alleged violations of Constitutional rights.

"If the FDA insists on calling itself and acting like a criminal law enforcement agency -- not a regulatory agency -- then it should be held to the same high standards of legal and ethical conduct that are required of all other law enforcement agencies," states Anast.

He says, "We comment because the regulated medical companies are so intimidated by the possibility of retribution, that they do not raise these issues individually and publicly." He calls on various medical trade associations to consider legal challenges to the FDA's activities, and invites comments, pro or con.

Anast says FDA official admits in writing that on-site inspectors can't be bothered with noting for the record, that deficiencies found by inspectors were corrected prior to completion of the inspection. "This is a troubling admission on how FDA officials conduct themselves. If inaccurate, incorrect and incomplete information is included in materials that may help launch a criminal prosecution, doesn't that raise any questions, problems and concerns?" says Anast.

"If FDA inspectors are now focusing on inspections to gather evidence for subsequent criminal prosecution, as it has been alleged, instead of gathering information for ensuring quality of medical products, hasn't a line been crossed?" he notes.

After consultations with legal authorities, Anast asserts the 4th Amendment to the Constitution guaranteeing everyone's rights against unreasonable search and seizure activities, plus the 5th and 6th Amendments, are being violated. "Shouldn't the search warrant process be required here, and rights regarding legal counsel, self-incrimination, due process, etc. be observed, or does the FDA consider itself exempt from the Constitution?" Anast, who has bachelors and masters degrees in public administration, has been reporting on the FDA since 1980.

For details, interviews or to subscribe, contact BMN: 714/434-9500. Subscriptions are $695 per year U.S., $790 non-U.S. Sample issues: $55 + $5 s/h.

CONTACT: Biomedical Market Newsletter, Costa Mesa

Dave Anast, 714/434-9500