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CCH NetNews™
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(June 10, 2008)
Food and Drug Law
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New and Improved
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Featured This Week:
Isomaltulose interim final rule adopted
— The FDA adopted, without change, an interim final rule that permits
health claims about noncariogenic carbohydrate sweeteners made from isomaltulose
not promoting dental decay. The FDA published the interim final rule on September
17, 2007, in response to a health claim petition submitted on behalf of Cargill,
Inc. The FDA only received two relevant comments suggesting that there had
been insufficient testing, but the commenters failed to provide any information
to support a revision of the FDA's conclusion. The rule change was effective
on May 27, 2008.
FDA Order ¶40,346D.
Amended pregnancy and lactation labeling proposed
— The FDA proposed to amend its regulations concerning the format and
content of the pregnancy, labor and delivery, and nursing mothers subsections
of the “Use in Specific Populations” labeling section on prescription
drug inserts. The proposal would eliminate the current pregnancy categories
A, B, C, D, and X, because those categories confuse the way risk is categorized.for
human prescription drug and biological products. The FDA proposed, instead,
that labeling include a concise summary of risks of using a drug during pregnancy
and lactation and a discussion of the data supporting that summary. The labeling
would also include relevant clinical information to help health care providers
make prescribing decisions and counsel women about the use of drugs during
pregnancy and/or lactation. Comments are due by August 28, 2008.
FDA Proposal,
¶46,127D.
Registry implementation delayed; comments requested
— The Reportable Food Registry (the Registry) mandated by the Food and
Drug Administration Amendments Act of 2007 for start up by September 27, 2008
will be delayed. The FDA now intends to implement the FDAAA requirement to
establish the electronic portal for reportable food by utilizing the business
enterprise system currently under development by the agency, and it expects
that the business enterprise system will not be operational until spring 2009.
Comments on the Registry are due by August 10, 2008.
FDA Notice,
¶43,684D.
Unlawful prescription of controlled substances
— A jury that convicted a doctor of prescribing controlled substances
with no legitimate medical purpose could have reasonably inferred that the
doctor's cursory patient examinations were merely designed to give the appearance
of propriety, according to the U.S. Court of Appeals for the Third Circuit.
The doctor argued that he prescribed narcotics in the usual course of his
medical practice and followed a Drug Enforcement Administration (DEA) bulletin
on Internet prescribing, even though he had face-to-face encounters with DEA
undercover “patients.” The DEA's requirements for Internet prescribing
are not necessarily synonymous with the Controlled Substances Act's (CSA)
requirement that prescriptions be issued for a legitimate medical purpose
by a practitioner acting in the usual course of his professional practice.
The jury heard overwhelming evidence that the doctor conducted only minimal
procedures designed to create the veneer of actual examinations. The doctor's
medical degree cannot protect him from criminal punishment under the CSA.
U.S. v. Maynard,
¶39,032D.
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