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CCH NetNews™
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(June 17, 2008)
Food and Drug Law
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New and Improved
Continuing to to provide you with the most
up-to-date, accurate information, CCH introduces new
enhancements for the Food,
Drug & Cosmetic Reporter and the Medical
Devices Reporter. These include:
- New food safety & security explanations,
incorporating Bioterrorism Act provisions
- Significant additions to the Hatch-Waxman
explanations on generic drug approvals
- New coverage of combination drug, biologics, and
device products
- More detailed explanations on drug, vet drug,
and device user fees
- Updated, comprehensive coverage of
over-the-counter drug monographs
- Additional reporting on food and drug good
manufacturing practices
The Food,
Drug & Cosmetic Reporter provides everything
you need to know about Food and Drug Regulations.
Full-text source covering federal and state laws and
regulations and court decisions that govern the
safety, effectiveness, purity, packaging and labeling
of food, drugs and cosmetics.
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Devices Reporter provides access to the full text
plus expert analysis of all laws and regulations
governing the classification, approval, manufacture,
and marketing of all medical diagnostic, and
radiological devices.
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Featured This Week:
Senate bill: conditionally-approved drugs for seriously ill
— The “Access, Compassion, Care and Ethics for Seriously-Ill Patients
(ACCESS) Act,” (S. 3046) was introduced as a bill in the Senate to
amend the FDC Act with a new “compassionate investigational access” section.
Drug, biologics and device sponsors could apply for compassionate use for
the seriously ill after Phase I clinical investigations have been completed
on products, if they have evidence of product safety and attest that they
are actively pursuing marketing approval for such products. The FDA would
have 30 days to approve compassionate use or refer an application to the new
Accelerated Approval Advisory Committee. In order to be eligible for a compassionate
use product, a patient would need to: be seriously ill, exhaust all treatment
options, and unsuccessfully seek or obtain conventional treatment that is
not effective.
S. 3046, 110th Cong. 2d Sess. (2008) ¶200,009.
Science Board will review bisphenol-A
— A subcommittee of the FDA's Science Board will hold a public meeting
on the safety of bisphenol-A (BPA) in plastics, review an agency task force
report on the topic, and deliver its findings to the Board's annual meeting
this fall. The FDA has been reviewing emerging literature on BPA on a continuous
basis for years and its food center initiated a formal reexamination of the
safety of BPA in early 2007. In April 2008, the National Toxicology Program
(NTP) of the National Institutes of Health published a draft brief indicating
that some studies in animals suggest that BPA may raise concerns for developmental
effects in humans. The NTP is collecting public comments on the draft and
scheduled a June 11, 2008, peer review meeting for the draft brief.
FDA News Release.
Direct-to-consumer advertising bill introduced
— The “Responsibility in Drug and Device Advertising Act of 2008,
” (H.R. 6151) was introduced as a bill in the U.S. House of Representatives
to amend the FDC Act to prohibit direct-to-consumer advertising of drugs and
devices for three years following FDA approval. The bill would permit the
Secretary to prohibit the direct-to-consumer advertising of a drug or a Class
II or Class III device after that three year period if the Secretary determines
the drug or device has significant adverse health effects based on post-approval
studies, risk benefit analyses, adverse events reports, the scientific literature,
any clinical or observational studies, or any other appropriate resource.
In addition, any direct-to-consumer advertising of a drug or Class II or Class
III device would be required to include a fair balance, as supported by the
evidence, of the benefits and risks associated with the drug or device.
H.R. 6151, 110th Cong. 2d Sess.,
¶200,098.
Falsely advertised dietary supplements
— The Federal Trade Commission (FTC) was entitled to a permanent injunction
against a common enterprise of companies and corporate officers who, falsely,
without reasonable basis and unsupported by competent and reliable scientific
evidence, advertised dietary supplements as being clinically proven to cause
weight loss or to treat erectile dysfunction, according to the U.S. District
Court for the Northern District of Georgia. The products included Lipodrene™
and Thermalean™for weight loss and Spontane-ES for erectile
dysfunction. The companies conducted no clinical research for the products
and their false advertising claims were material and likely to deceive consumers.
FTC v. National Urological Group, Inc..
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