Continue to Site

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Hamburg in as FDA chief

Hamburg in as FDA chief

By

Go directly to MassDevice. Having trouble reading this email? View this newsletter in your browser here.
Not interested? Unsubscribe.

The MassDevice Weekly Roundup brings you the latest medical device news and information.

News

Hamburg in as FDA chief
The U.S. Senate unanimously confirms Margaret Hamburg as 21st commissioner of the Food & Drug Administration. Read More more arrow

Osmetech jumps into the Swine Flu diagnostic race
Molecular diagnostics maker asks FDA to approve its respiratory pathogen test for emergency use in detecting the H1N1 virus. Read More read-more<br>

Heart docs: Defibrillator leads need more oversight
The FDA and companies that make defibrillator leads need to improve monitoring of the devices after they hit the market, according to the Heart Rhythm Society. Read More read-more<br>

hr

Features

Banned in Boston
Massachusetts enacted the nation’s strictest law governing industry payments to physicians. What does the so-called “gift ban” mean for the Commonwealth’s medical devices sector? Read More more arrow

hr

Blogs

MassDevice blog: General Electric looks to revolutionize the devices market
Will GE Healthcare’s move into smaller (and cheaper) medical devices hurt competitors, or is it the rising tide that lifts all boats? Read More more arrow

Healthcare blog: Reform: The other Massachusetts health plan
Every week, veteran healthcare reporter Tinker Ready rounds up the latest news for MassDevice. This week, she takes a look at the second stage of the Bay State’s groundbreaking healthcare reform plan, the end of the Swine Flu panic and the push for HIT adoption. Read More read-more<br>

Reimbursement Row: Healthcare players seek a seat at the table
The major players in the healthcare game (with one conspicuous exception) look to land a seat at the table when President Barack Obama’s reform initiative is hammered out. Read More more arrow

hr

The MassDevice Checkup

Our weekly checkup takes the temperature of the 63 public medical device companies in the MassDevice Index. In addition to the index itself, which tracks the overall movement of the sector, we compare Monday morning’s opening share prices with their value when the markets close Friday afternoon and calculate the biggest gainers and losers. The checkup also takes a look at a different financial metric each week, ranking local players based on their performance in that category. This week we examine research and development budgets, listing the top 20 R&D spenders in terms of percentage of revenues. Read More more arrow

Supplier Spotlight

This week, the Supplier Spotlight shines on the massPLASTICS Medical Device Connection, a portal to more than 35 innovative plastics companies comprising a cluster of qualified, global outsourcing partners for medical OEMs. It’s one of roughly 1,000 companies and service providers listed in the MassDevice Network. Browse the Network more arrow

If you would like to subscribe to this newsletter, please visit our member registration page.more arrow

© 2009 Massachusetts Medical Devices Journal LLC and its licensors. All rights reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of MMDJ.

www.MassDevice.com

More recent news

Hamburg in as FDA chief

By Leave a Comment

President Barack Obama’s nominee to lead the Food & Drug Administration, Margaret Hamburg, was unanimously confirmed last night by the U.S. Senate, according to news reports.

Hamburg, 53, has a wealth of public health experience. She’s received two degrees from Harvard and at 36 became New York City’s youngest health commissioner.

During her tenure in New York, she reduced tuberculosis rates by 46 percent between 1992 and 1997. She also supported a controversial needle exchange program to slow the spread of AIDS, increased childhood immunization rates and developed one of the first programs to prepare the public for a terrorist attack by anthrax or other bio-chemical weapon.

Hamburg’s not known to kowtow to higher authorities either. She challenged her boss, then-Mayor Rudy Giuliani, by summoning a health department aide to a City Council meeting whom Giuliani wanted canned. Arguing that science and not “wishful thinking” should drive AIDS education, Hamburg also publicly opposed an effort requiring AIDS educators to stress abstinence to city students, refusing to take a so-called “morality oath” in 1992.

The unanimous Senate vote came after weeks of behind-the-scenes wrangling by the device, drug, health and food lobbies, which were eager to see a more business-friendly, less consumer-friendly candidate take the helm of the federal watchdog.

Hamburg’s deputy, Joshua Sharfstein, has been running the agency as acting head since her nomination in March. Sharfstein also has a long pedigree in safety and consumer issues.

Her confirmation hearing was pushed up as the Swine Flu epidemic gained steam. The outbreak likely eased partisan objections to her appointment, despite her support of hot-buttons like FDA oversight of tobacco.

Hamburg says her top priority will be improving food safety; she’ll have more resources to do that if Congress approves Obama’s request for a $300 million boost to the FDA’s budget.

Food safety won’t be her only concern. In April the agency required the makers of 25 Class III medical devices approved before 1976 to submit safety and effectiveness data, ahead of a review that could lead to mandates for more stringent clinical human trials of the devices.

And amid calls for more oversight of the devices industry and public pleas from within the agency for dramatic reforms, she’ll be asked to ensure the safety of imports from China.

Filed Under: Uncategorized Tagged With:

More recent news

Reader Interactions

Leave a Reply

Copyright © 2024 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy