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CCH NetNews™
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(June 24, 2008)
Food and Drug Law
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Featured This Week:
Committee asks FDA to specify food safety plans
— The FDA has made little progress in carrying out the goals of preventing
and responding to food safety problems set forth in its Food Protection Plan,
according to the Government Accountability Office (GAO). The FDA released
its plan in November 2007, but the plan still lacks details on the resources
and strategies it needs to implement its plan, said Lisa Shames, Director
Natural Resources and Environment at the GAO. During a June 12, 2008 hearing
of the U.S. House of Representatives Energy and Commerce Oversight and Investigations
Subcommittee, Ms. Shames said that the FDA’s proposal to focus inspections
based on risk has the potential to be an efficient and effective approach,
although the FDA has implemented few of the GAO’s recommendations intended
to help leverage resources and improve operations. The FDA said its plan would
take five years to implement, but the GAO has not received enough specifics
to assess that goal.
GAO Testimony,
¶100,912.
Administration asks for $275 million more for FDA in FY 2009
— HHS Secretary Leavitt announced on June 9, 2008, that the Bush Administration will
request an additional $275 million for the FDA for fiscal year (FY) 2009.
The increase would boost the FDA's budget for FY 2009 to $404.7 million..
The budget increase reflects the need for increased inspections of imported
food and medical products as well as the cost of establishing FDA posts in
exporting countries. The funds would expedite implementation of the strategy
outlined in the Action Plan for Import Safety, and the complementary Food
Protection Plan. The food protection plan would receive an additional $125
million. As well, additional funds would be used to track drugs and devices
to ensure postmarket safety, and the FDA's capacity to support emerging scientific
studies would be strengthened.
HHS News Release,
¶100,908.
Hearing on salt in foods comment period extended
— The FDA reopened the comment period until August 10, 2008, on salt daily-value
labeling. Comments were first requested on October 23, 2007. The Center for
Science in the Public Interest filed a citizen petition in 2005 requesting
that: (1) the FDA revoke salt's generally-recognized-as-safe status, (2) health
messages about salt appear on food labels, and (3) daily values for salt be
reduced. In 2006 the agency issued a tentative response to the petition, saying
that additional information was needed. Comments are now due by August 10,
2008.
FDA Notice,
¶43,689D.
Edetate disodium products removed from market
— The FDA withdrew approval of one new drug application and two abbreviated
new drug applications for edetate disodium injection. The withdrawals were
instituted because of medication errors. As noted in an FDA January 16, 2008,
Public Health Advisory, children and adults died when mistakenly given edetate
disodium instead of edetate calcium disodium or when edetate disodium was
used for indications other than those approved by the agency. Edetate disodium
is used for the treatment of hypercalcemia and for the control of ventricular
arrhythmias associated with digitalis toxicity. The FDA asked Hospira, Apotex,
and Bionice to voluntarily remove their products from the market, and all
three pharmaceutical companies agreed in writing to the agency's request and
waived their opportunity for a hearing.
FDA Notice,
¶100,909.
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