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Obama, McCain Agree on Speeding Generic Medicines to Market

September 22, 2008 2:00 AM | Permalink | Comments (0)

By Meghan McCarthy, CQ Staff

No matter who wins November's presidential election, biotech drug manufacturers are unlikely to get the 14-year period of data exclusivity they seek as part of follow-on biologics drug legislation, according to the candidates' top health policy advisers.

At an annual generics industry conference last week hosted by the Generic Pharmaceutical Association (GPhA), Douglas Holtz-Eakin, adviser to GOP nominee John McCain , and Dora Hughes, senior health adviser to Democratic nominee Barack Obama , said both candidates support the shortest time period possible.

Tags: biologics, biotechnology, FDA, generic medicines, McCain, Meghan McCarthy, Obama

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Industry Goes on Offense on Medical Device Approvals

September 5, 2008 12:04 AM | Permalink | Comments (0)

By Meghan McCarthy

A new report from the Advanced Medical Technology Association, or AdvaMed, aims to stress the safety and efficacy of the current Food and Drug Administration (FDA) process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountability Office (GAO) report.

GAO reports released in January and May of this year have been highly critical of the FDA's medical device approval processes. The reports found that the agency has not met requirements to inspect domestic plants manufacturing medical devices every two years, and that FDA also faces major challenges inspecting foreign establishments. The new GAO report is expected to be released in September.

Tags: AdvaMed, FDA, medical devices, Meghan McCarthy

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Clinical Trial of Cancer Drug is a First

July 16, 2008 7:00 AM | Permalink | Comments (0)

By Meghan McCarthy, CQ Staff

Despite the lack of an established Food and Drug Administration approval pathway for follow-on biologics, biotech company Insmed says it intends to begin a clinical trial of its new follow-on biologic that is similar to Neupogen, a cancer drug produced by Amgen.

(Follow-on biologics are generic versions of complex biotech medicines. The biotech industry says that truly identical, generic versions of its drugs are impossible; generic manufacturers can only hope to produce similar products.)

Tags: Amgen, cancer, FDA, Insmed, Meghan McCarthy, Neupogen

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Testing Genes to Find New Treatments

July 15, 2008 7:00 AM | Permalink | Comments (0)

Five Questions for Kathy Hudson, Director, Genetics and Public Policy Center

Kathy Hudson is the former Assistant Director of the National Human Genome Research Institute, the 13-year effort coordinated by the federal government to map human DNA. In 2002, she founded the center, which is funded by The Pew Charitable Trusts and located at Johns Hopkins University, to focus on public policy issues raised by genetic research.

Q: What's your hope when the new law against genetic-based discrimination takes effect (1- 1 ½ years from now)?

A. My hope is that patients and prospective research participants will be able to make informed decisions about whether to participate in research or whether to have a genetic test unencumbered by concerns that their genetic test results or their participation in research could come back and bite them.

Tags: DNA, FDA, genetics, Genetics and Public Policy Center, Kathy Hudson

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High-Tech Home Health Help

July 13, 2008 4:39 PM | Permalink | Comments (0)

Microprocessor-maker Intel is getting into the high-tech health business: its Health Guide has won approval from the Food and Drug Administration. The device records vital signs and allows for videoconferencing with doctors or nurses in remote locations. Daily Tech says Intel is marketing the device to nursing homes and care centers, and also expects that chronically ill people who live in their own homes might purchase the Guide.

Web pick posted by Neil Savage, Xconomy.com

Tags: Daily Tech, FDA, Intel

Web Pick: Heart Imaging Drugs Can Cause Death, FDA Warns

June 20, 2008 3:45 PM | Permalink | Comments (0)

The continued use of certain drugs, known as contrast agents, to improve echocardiogram (ultrasound) images of the heart is leading to deaths, the Food and Drug Administration says.

An AP story on Forbes.com reports that the FDA put out a warning in October, but since then has received four reports of patients dying after being injected with Definity, a drug formerly marketed by Bristol Myers Squibb.

Researchers are always trying to develop agents that are easier to see on ultrasound or MRI scans as a way to spot hard-to-find defects.

Tags: Bristol Myers Squibb, Definity, FDA, heart