| November 3, 2009 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- Bioscience advocates call for biogeneric support
In a letter to the editor, Delaware BioScience Association President Bob Dayton and Biotechnology Industry Organization President and CEO Jim Greenwood call on Delaware's lawmakers to protect consumer safety and ensure innovation of biogenerics as Congress works on health care reform. Creating an avenue for regulatory approval would ensure biogenerics "are tested for safety while expanding access, lowering costs through expanded competition and providing incentives for biotech companies to continue innovating," they write. delawareonline
(11/2)
 
| Health Care in Transition | | |
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- House GOPs criticize "federal bureaucracies" in health proposal
Republicans in the House of Representatives warned that the Democrats' health reform proposal would create 111 new federal bureaucracies, programs and boards, citing a health insurance exchange, an FDA women's health unit and a CMS center for innovation, among others. A Democratic source said the "bureaucracies" are only new "programs and demonstration projects" that would be used to "test new policies before more broadly implementing them." FoxNews.com
(11/2)
- Debate in House continues over abortion, immigrants in health bill
House Democrats are still struggling to finalize provisions on funding for abortions and insurance coverage for immigrants in the health reform legislation. Some worry that the bill would allow illegal immigrants to use the public option if they pay out-of-pocket for the insurance premiums. The lawmakers are also working on tightening language regarding abortion funding to prevent underwriting and exclude the procedure from the government-run insurance plan. The Wall Street Journal
(11/3)
- CBO: Public option in House bill would charge higher premiums
Premiums in a government-run insurance plan proposed by House Democrats would cost "somewhat higher" than private policies sold on the government-sponsored exchange to be created for small businesses and individuals, the Congressional Budget Office said. The higher fees may be attributed to House Speaker Nancy Pelosi's decision to allow doctors' fees to be negotiable in the public option rather than peg them with Medicare rates to cut costs. Bloomberg
(11/3)
| Biotechnology | | |
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- Judge allows continuation of lawsuit against gene patents
A U.S. federal judge did not dismiss a lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation for two genes linked to breast and ovarian cancers. The lawsuit, which was filed by the American Civil Liberties Union, claims that human genes should not be patented because they are "products of nature." Myriad Genetics' legal counsel had no immediate comment on the case. Reuters
(11/2)
| Food & Dietary Ingredients | | |
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- Consumers Union analysis finds BPA in canned foods
An analysis by Consumers Union found measurable levels of the chemical additive bisphenol A, or BPA, in a number of canned goods, some of which had "BPA free" labels. An American Chemistry Council spokesman countered that the results of the analysis were "inconsistent with the conclusions of expert regulators worldwide, all of which have confirmed that BPA exposure levels are low, and well within safety standards." Los Angeles Times
(11/3)
| Medical Devices | | |
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- FDA questions Zimmer payments to doctors in device trial
FDA reviewers said Zimmer Holdings' Dynesys implant is at least as effective as the company's Silhouette implant in treating spinal problems, but raised questions about the possible influence of the firm's financial ties to doctors conducting the device trial. A company spokesman didn't immediately comment on the issue. An FDA panel is set to meet Wednesday to discuss the product. Google/The Associated Press
(11/2)
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