March 2007 - Pharmaceutical Technology

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March 2007

Pharmaceutical Technology


Bigger cuts

Despite its growth, the FDA budget is barely a blip in the administration's $2.9-trillion federal spending plan, or in the $700-billion budget for the US Department of Health and Human Services (most of which is mandated spending for Medicare and Medicaid). Thus, to curb the "unsustainable growth of federal entitlement programs," the Bush administration seeks more than $100 billion in Medicare savings over five years, largely by freezing payments to hospitals, nursing homes, and physicians.

Healthcare providers immediately set in motion plans to kill the fee cuts, while Congressional Democrats fumed that the budget was dead on arrival. Administration supporters described the administration's proposal as the "opening bid" in the battle to reduce the budget deficit, a task made more difficult by huge increases in spending for the war in Iraq.

A controversial proposal is to have wealthier seniors pay higher premiums for Medicare benefits, including premiums for Medicare prescription drug plans. Additional cuts would hit Medicaid and the Children's Health Insurance Program (CHIP), which has to be reauthorized by Congress this year. With pressure high on the legislators to find more money for Medicare, CHIP, and other health programs, added funding for FDA is far from a done deal.

-Jill Wechsler

VACCINES

HHS Offers Liability Protections for Flu Vaccine Manufacturers



Washington, DC (Jan. 26)—The US Department of Health and Human Services (HHS, http://www.hhs.gov/) has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

The new declaration states that manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims. According to the Federal Register notice, it is "intended to alleviate certain liability concerns associated with pandemic countermeasures, and, therefore, ensure that the countermeasures are available and can be administered in the event an avian influenza virus spreads and evolves into a strain capable of causing a pandemic."

With this measure, HHS hopes to encourage the development, clinical testing, manufacture, and distribution of an influenza A vaccine. The declaration went into effect Dec. 1, 2006 and continues through Feb. 28, 2010.

–Brianne Harrison

PROCESSING INGREDIENTS

FDA Proposes Ban on Cattle Tissue in Drugs



Rockville, MD (Jan. 12)—To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration ( http://www.fda.gov/) has proposed banning certain cattle tissues and tissue products from the manufacture of drugs for human and ruminant use.

The proposal, "Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule" (published in the Jan.12 Federal Register, pp. 1581–1619), estimates that cattle products of some kind are used in 75% of pharmaceutical manufacturing—and 90% of biotechnology processes. The proposal notes, however, that the agency has reviewed 10 years of data on cattle products used in drug-manufacturing and "we are aware of no approved drugs and no investigational drugs that are manufactured with cattle material that would be prohibited under this proposed rule ...."


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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