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CCH NetNews™
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(July 8, 2008)
Food and Drug Law
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New and Improved
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and device user fees
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manufacturing practices
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Featured This Week:
Antimicrobial food additive submissions
— A guidance for firms making antimicrobial food additives and food contact
substances in designing studies to determine whether an antimicrobial food
additive achieves its intended technical effect has been issued by the FDA.
To demonstrate that an antimicrobial agent achieves its intended technical
effect and that the proposed use level is the minimum level necessary to accomplish
the intended technical effect, the following information is recommended at
a minimum: (1) chemical or biological identity of the agent, (2) detailed
description of intended microbial effect, (3) description of the conditions
of use and any limitations on conditions of use, (4) efficacy studies, (5)
sample of the label proposed for the food additive, and (6) for petitions,
proposed wording for establishing or amending a food additive regulation.
FDA Guidance,
¶330,384.
DEA proposes revised 2008 quotas for ephedrine
— The Drug Enforcement Administration (DEA) proposed revised assessment
2008 production and import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine
to prevent the illicit use of these three chemicals in the manufacture of
methamphetamine. The DEA set the proposed revised 2008 quotas at the same
levels as 2007 final quotas: ephedrine (for sale), 11,500 kilograms (kg);
ephedrine (for conversion), 128,760 kg; pseudoephedrine (for sale), 511,100
kg; phenylpropanolamine (for sale), 5,545 kg; and, phenylpropanolamine (for
conversion), 85,470 kg. Comments are due by July 23, 2008.
DEA Notice,
¶43,690D.
Generic drugs: warning labels
— Labeling for generic drugs must always remain the “same as” that
of listed brand name drugs and generic drug manufacturers cannot unilaterally
change labeling without prior FDA approval. Following an FDA requirement,
generic manufacturers revised the labeling for a drug, metoclopramide, regarding
the risk of tardive dyskinesia. A patient who developed tardive dykinesia
after taking such generic drugs for four years sued, asserting that the generic
manufacturers failed to adequately warn about the association between long-term
ingestion of the drug and movement disorders. The generic drug manufacturers
argued that the patient's claims were preempted by federal law. According
to the U.S. District Court for the District of Minnesota, under abbreviated
new drug application procedures, a generic manufacturer is required to put
exactly the same language on its warning labels as the listed drug. Any duty
to unilaterally heighten the warning labels would directly conflict with federal
law requiring that generic labels be the same as listed drug labels, and there
is no legal duty to propose revised labeling or undertake independent communication
with health care professionals. The company's motion to dismiss was granted.
Mensing v. Wyeth, Inc. d/b/a Wyeth, D. Minn.,
¶39,035D.
Bill: transferable tropical disease review vouchers
— Section 1102 of the Food and Drug Administration Amendments Act of 2007
(P.L. 110-85) created an FDA priority review program for new drug applications
for tropical diseases such as malaria and cholera. The law requires the FDA
to act within six months of receipt of these applications. The agency
gives “priority review vouchers” to sponsors of products for tropical diseases.
The vouchers are transferable. A new Senate bill introduced on June 18, 2008,
by Senator Sherrod Brown (D-Ohio) would increase the transferability of these
vouchers. Instead of merely permitting the transfer of vouchers from a sponsor
to another sponsor, the bill would generally permit all transfers, including
sales. The bill provides, however, that no voucher may be redeemed to affect
the review of a pending human drug application.
S. 3151, 110th Cong.,
2d Sess (2008),
¶200,101.
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