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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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Report: Increased Competition Will Produce Better, Cheaper Medicines

September 18, 2008 3:00 AM | Permalink | Comments (0)

By Meghan McCarthy, CQ Staff

More competition among manufacturers of brand name and generic will create better and cheaper biotech drugs, according to a study released Wednesday by the generic pharmaceutical company Teva Pharmaceuticals USA.

Conducted by Boston University Economics Professor Larry Kotlikoff, the study invokes traditional economic theory as it argues that monopolies discourage innovation, which flourishes in a competitive environment.

Tags: biologics, biotechnology, Meghan McCarthy, Teva Pharmaceuticals

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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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Universities: Data Exclusivity Necessary for Creation of New Biologics

June 29, 2008 7:00 AM | Permalink | Comments (0)

By Meghan McCarthy, CQ Staff

The Association of American Universities, a coalition of 60 research universities, has written a letter to Reps. Anna G. Eshoo , D-Calif., and Joe L. Barton , R-Texas, in support of the lawmakers' legislation that would create an approval pathway for follow-on biologics (HR 5629). The letter highlights the bill's proposed data exclusivity period as essential to funding the creation of new biologic products.

Tags: Association of American Universities, biologics, Meghan McCarthy

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