Navigation Links
FDA, States Weigh Pharmacy Regulation in Wake of Meningitis Outbreak
Date:12/20/2012

THURSDAY, Dec. 20 (HealthDay News) -- State public health officials want the U.S. Food and Drug Administration to play a stronger role in regulating large-scale compounding pharmacies to prevent tragedies like the recent nationwide meningitis outbreak, officials said at a meeting in Washington, D.C., on Wednesday.

Health officials from 50 states and FDA representatives met to discuss regulatory concerns after contaminated vials of a steroid medication for back and joint pain sickened 620 people with meningitis in 19 states. Thirty-nine have died. All received injections for back pain made by a Massachusetts-based specialty drug firm called the New England Compounding Center.

Typically, states -- not the FDA -- govern pharmacies, but many states lack the resources to oversee large-scale operations such as the New England Compounding Center (NECC), the state officials said, according to The New York Times.

"The consensus in our group was that there is a role for the FDA to be involved in facilities like NECC," Cody Wiberg, executive director of the Minnesota Board of Pharmacy, told the Times. "If you're talking about compounding, most states have the authority and resources to handle that," he said. Not as many states can effectively oversee manufacturing enterprises such as the New England Compounding Center, he added.

Compounding pharmacies mix or alter ingredients to create drugs to meet specific needs of individual patients, but the business has mushroomed since the 1990s. And FDA Commissioner Dr. Margaret Hamburg told the newspaper that the laws have not kept pace with changes in the industry.

"It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted," said Hamburg, who called for greater oversight by the FDA in testimony before Congress last month.

But she and others expressed concern that heavy-handed measures might harm the health care system. The ability to tailor medications to individual patients is important, experts noted.

Some critics have said the FDA has shirked its responsibilities. "There should be one uniform federal standard that is enforced by one agency -- the FDA," Michael Carome, deputy director of the consumer advocacy organization Public Citizen's Health Research Group, told the Times. "They have been lax in enforcing that standard."

The New England Compounding Center ceased operations after the start of the meningitis outbreak early in October.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers. Some members of Congress have called for greater FDA regulation of these businesses.

The owner of the New England Compounding Center refused last month to testify before a House of Representatives committee investigating the steroid/meningitis outbreak.

Meningitis is inflammation of the membranes that surround the brain and spinal cord. The steroid injections were used on patients complaining of back or joint pain.

FDA investigators who toured the New England Compounding Center's Framingham plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, federal health officials said. The contaminated product was one of a host of potential violations discovered during the recent inspection, the officials said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the New England Compounding Center.

More information

The U.S. National Library of Medicine has more about injections for back pain.

-- HealthDay staff

SOURCE: The New York Times; U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Majority of states fail to address youth exposure to alcohol marketing
2. Injury-Linked Deaths Vary Widely Among States
3. Strokes More Common in Southern States: CDC
4. States Use Only Fraction of Tobacco Revenues to Fight Smoking, Study Finds
5. Ohio Mail-Order Hatchery Now Linked to Salmonella in 23 States
6. Is it constitutional for states to regulate pharmaceutical gifts and meals to doctors?
7. States' Next Steps on Health Reform - Will They Launch Exchanges?
8. Lung cancer death rates among young and middle-aged white women climb in some states
9. New study finds increase in track-related injuries among youth in the United States
10. Reducing Ozone Limits Would Save Lives, Report States
11. New FDA program adds to tools to curb opiod abuse in United States
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA, States Weigh Pharmacy Regulation in Wake of Meningitis Outbreak
(Date:6/27/2016)... ... 2016 , ... "FCPX editors can now reveal their media with growing colorful ... Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings the ... can now reveal the media of their split screens with growing colorful panels. , ...
(Date:6/26/2016)... , ... June 27, 2016 , ... Quality metrics are ... in many ways they remain in the eye of the beholder, according to experts ... publication of The American Journal of Managed Care. For the full issue, click ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
Breaking Medicine Technology: