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| FDLI SmartBrief |
| November 3, 2009 |
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.com (Wilmington) (11/2)
FDA decides against Lipitor-Zetia combo
The FDA rejected an application to market cholesterol drugs Lipitor and Zetia as a combination treatment because of a lack of manufacturing and stability data. Merck & Co., which developed Zetia with Schering-Plough, said it is reviewing the complete-response letter "to determine a new timetable for filing." The Wall Street Journal/Dow Jones Newswires (11/2)
FDA approves changes to Byetta label
The FDA approved a revised label for diabetes drug Byetta to include reports of problems with kidney function. The decision came days after Eli Lilly and Co. and Amylin Pharmaceuticals received clearance to promote Byetta as a stand-alone treatment for Type 2 diabetes. Reuters (11/2) The Wall Street Journal/Dow Jones Newswires (11/2)
FDA wants another trial of GTx's prostate cancer drug
The FDA ordered GTx to conduct a second Phase III trial of toremifene citrate to prove the drug's efficacy in reducing fractures in prostate cancer patients. GTx CEO Mitchell Steiner said the agency should have informed the company that two such trials were needed, adding that there already is "sufficient information to satisfy the request." American City Business Journals/Memphis, Tenn. (11/2)
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)
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)
Tainted beef might be tied to 2 deaths
Officials with the U.S. Centers for Disease Control and Prevention say E. coli bacteria in fresh ground beef products may have caused two deaths and 28 people in Northeastern states to fall ill. Ashville, N.Y.-based Fairbank Farms has recalled the beef. Reuters (11/2) The Wall Street Journal/The Associated Press (11/2)
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)
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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)
Kinetic Concepts gets Japanese approval for wound-care system
Kinetic Concepts has received final marketing approval from Japan's Ministry of Health, Labor and Welfare for its V.A.C. Therapy System designed to treat difficult-to-heal wounds. The company expects the Japanese government to grant reimbursement approval for the product during the first half of next year. American City Business Journals/San Antonio (11/2)
This Thursday and Friday -- Introduction to Drug Law and Regulation, Nov. 5 and 6 -- Earn CLEs
Introduction to Drug Law and Regulation covers the essential elements of the laws and regulations that affect the drug industry. The course provides an overview of FDA and details of new drug applications, ANDAs, OTC, manufacturing, marketing, imports/exports and other drug regulation topics. Breakout sessions provide practical application of topics. Register today.
Downloadable products and CD library
Viewpoints on FDA: Enforcement is a downloadable PDF containing the transcript of Commissioner Hamburg's Aug. 6 speech, interviews with senior FDA officials, and articles on close-out letters and recent enforcement actions. If you missed the Oct. 13 and 14 Enforcement conference, download the Oct. 13 Compliance Central session audio. FDLI offers recordings of other programs on CD. View the list of programs that have a CD.
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