Drugs & Biologics

• Amphastar-Momenta rivalry regarding generic heparin intensifies
  Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa, launched an investigation into Amphastar Pharmaceuticals' hiring of security company Kroll, as the drugmaker competes with Momenta Pharmaceuticals to gain FDA approval for a generic version of low-molecular-weight heparin. Amphastar's general counsel said the company asked Kroll to look into a possible conflict of interest between Janet Woodcock, head of the FDA's drug unit, and a co-founder of Momenta. The Wall Street Journal (11/2)

• Amgen accused of giving kickbacks to boost Aranesp sales
  Fifteen states sued Amgen for allegedly bribing health care providers to bill insurers for anemia drug Aranesp, leading to overpayment from Medicaid and private insurance companies. The claims are without merit, Amgen said, and it is prepared "to examine these matters with the states before the court." Los Angeles Times (10/31)

• FDA approves Covidien's generic Actiq
  The FDA approved Covidien's version of Actiq, a pain drug from Cephalon used in cancer patients who do not respond to other drugs. Covidien plans to sell six doses of the drug, fentanyl citrate, early next year. Forbes/The Associated Press (10/30)

Health Care in Transition

• Republicans question cost of new health care bill
  Republicans on Capitol Hill are saying that the new health care bill unveiled by House leaders would cost more than $1 trillion, instead of meeting the spending limit of $900 billion over the next 10 years set by President Barack Obama. The nonpartisan Congressional Budget Office's initial estimate placed the cost of extending coverage to an additional 36 million Americans at $1.055 trillion over the next decade under the House plan. House leaders say the estimated net cost, after money raised from penalties, is $894 billion over 10 years. The Washington Post (10/31)

• Rep. Boehner: GOP to introduce health reform plan soon: House Minority Leader John Boehner, R-Ohio, said Sunday that Republican lawmakers are preparing to introduce their own health reform proposal that would be less costly to taxpayers and take "a step-by-step approach" to expanding insurance coverage with limited government intrusion. The GOP plan, which would be scored by the Congressional Budget Office, would also leave out mandatory insurance for individuals and businesses, Boehner said. The Wall Street Journal (11/2) , The Huffington Post (11/1)

• House liberals may agree to compromise health legislation
  Many House Democrats may be open to a compromise health reform bill despite concerns over a weaker version of the public option in the legislation. Some members of the Progressive, Black, Hispanic and Asian-Pacific American caucuses shared their views following a meeting with President Barack Obama on Thursday evening. Google/The Associated Press (10/31)

• Device firms in Tennessee, Georgia oppose House health plan
  A House health reform bill that would impose a lowered $20 billion tax on medical device firms over a decade is drawing criticism from manufacturers and vendors in Tennessee and Georgia because they think the proposal would still result in job cuts and a reduction in research spending. "It's bad news in Georgia and Tennessee, as we're trying to catch up and develop a medical device industry along the lines of some of the other states," said Rick Haury, the Southeastern Medical Device Association's founder. Chattanooga Times Free Press (Tenn.) (11/1)

• Group says health care bill could cost imaging industry $4.3B
  A health care reform bill recently unveiled by the House of Representatives contains proposals that would increase the presumed equipment-use rate for Medicare reimbursement from 50% to 75% and impose a 2.5% surcharge on the purchase price of new imaging equipment. The changes could cost the medical imaging industry $4.3 billion over 10 years, Access to Medical Imaging Coalition Executive Director Tim Trysla said. The group is planning to lobby the House regarding an exemption to the equipment surcharge. Diagnostic Imaging (10/30)

Biotechnology

• Geron, FDA reach deal regarding trials of spinal-injury therapy
  Geron said it might be able to resume early-stage trials of a stem cell treatment for complete thoracic spinal cord injury by the third quarter of 2010 under an agreement with the FDA. The agency had placed the studies on clinical hold after the treatment caused cysts in some animal subjects. American City Business Journals/San Francisco (10/30) , Reuters (10/30)

Food & Dietary Ingredients

• FDA scientists find "good" bacteria may fight salmonella
  FDA scientists have identified "good" bacteria that could fight salmonella bacteria in tomatoes. Although the "good" bacteria don't seem to have negative effects on humans, further studies are needed to prove the safety of the process, they said. The Washington Post (10/31)

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Featured Content

Medical Devices

• 2010 Medicare fee schedule increases assumed equipment-use rate
  The CMS on Friday announced that it is increasing the assumed equipment-use rate for medical equipment, including diagnostic imaging systems, from 50% to 90% as part of the new 2010 Medicare fee schedule rules. The agency also said it will require suppliers of advanced imaging services to be accredited by 2012. The new equipment utilization rate for medical imaging systems that cost more than $1 million will be introduced gradually over a four-year period. Diagnostic Imaging (11/2)

Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• Sales rep says he promoted Risperdal for off-label use (Bloomberg)

• AstraZeneca agrees to $520M settlement in Seroquel cases (The New York Times)

• NIH chief: Comparative studies hold risk for personalized medicine (Reuters)

• GAO: FDA fails to track drugmakers conducting postmarket studies (The New York Times)

• FDA allows use of peramivir in some H1N1 flu patients (The Wall Street Journal)

• Results based on number of times each story was clicked by readers.

FDLI Items

• Next week! Tobacco Product Regulation conference, Nov. 10
  This conference brings together various perspectives on the topics:
  
• Origins of the Family Smoking Prevention and Tobacco Control Act of 2009
• The statute's key provisions and challenges facing FDA
• The scientific basis for tobacco regulation
• Legal issues raised by the legislation and in pending litigation
• The regulatory challenges facing FDA, industry and the states
Register today! Earn CLEs!

• How does the federal government regulate software? Purchase your copy of "Biomedical Software Regulation"
  As health information technology becomes a centerpiece in the administration's reform initiatives, there is much to learn. This guide summarizes regulations promulgated by FDA and CMS, and provides reference materials and documents for use by regulatory and compliance specialists. It covers regulation of software: validation; medical imaging; electronic recordkeeping; clinical trials; and laboratory information management systems. Purchase today.

Manager, Commercial Compliance - Auditing Amylin Pharmaceuticals San Diego, CA Account Manager Alfa Laval, Inc. Omaha, NE

Editor's Note

• What will affect your industry most in 2010?
  Look out for the FDLI SmartBrief Year-End Report on Dec. 8 and 15. The results of this poll will appear in Part 2 on Dec. 15.

	New/updated FDA safety measures
	Heightened federal focus on health information technology
	The possibility of a public option for health insurance

SmartQuote

Accept the challenges so that you may feel the exhilaration of victory." --George S. Patton Jr., World War II general