March 2007 - Pharmaceutical Technology

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PharmTech Europe

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


HHS Offers Liability Protections for Flu Vaccine Manufacturers

Washington, DC (Jan. 26)—The US Department of Health and Human Services (HHS, 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


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 ( 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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Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
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