Congressmen fault FDA for not preventing fungal meningitis outbr - WSLS 10 NBC in Roanoke/Lynchburg Va

Congressmen fault FDA for not preventing fungal meningitis outbreak

Posted: Updated:

MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) - House lawmakers said Tuesday that the Food and Drug Administration had numerous opportunities over nearly a decade to stop the Massachusetts pharmacy responsible for a deadly meningitis outbreak that has killed more than 50 Americans.

Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others.

In the second hearing on the outbreak, FDA Commissioner Margaret Hamburg reiterated that her agency needs clearer authority to go after compounding pharmacies, which have challenged the FDA's authority in court since the 1990s.

Hamburg said her agency is working to crack down on compounding pharmacies, despite legal challenges.

"I wish we had been more aggressive, and I can assure you that we are being more aggressive now," Hamburg told lawmakers.

The wave of fungal meningitis infections was first identified in September and grew into one of the deadliest medication-related outbreaks in U.S. history. The NECC halted operations in October and faces over 100 lawsuits in federal court.

But more than half a year later, lawmakers in Washington continue to debate who should be held accountable for the outbreak and whether it could have been prevented.

Republicans said Tuesday that the FDA should have shut down the NECC based on complaints from doctors, patients, hospitals and state pharmacy regulators. The FDA first inspected the NECC in 2002 and issued a warning letter in 2006 over the pharmacy's production of copies of manufactured drugs without patient prescriptions. Between 2007 and 2012 the FDA continued to receive complaints about the company from anonymous whistleblowers and state pharmacy regulators, according to internal documents released by the committee.

"Ten years of warning signs, alarm bells, and flashing red lights were deliberately ignored," said Rep. Tim Murphy, R-Pa., who chairs the House Energy and Commerce Subcommittee on Oversight and Investigations. Murphy and other Republicans pointed to correspondence in thousands of pages of FDA documents turned over to the committee.

Democrats agreed that the FDA should have been more aggressive, but also supported the agency's argument that outdated laws and conflicting court decisions have hamstrung federal efforts at policing pharmacies.

"These documents show us that the FDA has been grappling with a law that is broken, and we need to help fix that law and keep the American public safe," said Rep. Diana Degette, D-Colo., the subcommittee's ranking member.

Compounding pharmacies mix customized medications based on doctors' prescriptions, and have traditionally been overseen by state pharmacy boards. But in recent years, the FDA has tried to police larger compounders like the NECC, which operate more like manufacturers by mass producing drugs and shipping them across state lines.

Last week the FDA completed a wave of inspections targeting about 30 compounding pharmacies with a history of complaints or problems. Inspectors reported finding a host of potential safety hazards, including rust and mold in supposedly sterile rooms.

Republicans charged that this "flurry of well-publicized activity" only proves that FDA has the ability to shut down pharmacies like the NECC.

"No law has changed. The only change is the FDA decided to act," Murphy said.

Republicans pressured Hamburg to explain a 2011 FDA decision to suspend routine inspections of compounding pharmacies, including the NECC. Hamburg said agency lawyers recommended the halt in enforcement due to legal questions about the agency's authority to police compounding pharmacies. Hamburg told lawmakers she was unaware of the policy at the time.

"I regret that I was not more fully aware," Hamburg said.

Congressional Democrats acknowledged that the FDA did not act quickly enough, but placed the blame on a complicated legal landscape.

Rep. Henry Waxman, D-Calif., and other Democrats said Congress should pass be working to clarify FDA's authority.

An effort to draft new legislation on compounding pharmacies has made little headway in the House, which is controlled by Republicans. However, Senate lawmakers are expected to introduce a bill in coming weeks that would subject large compounding pharmacies to new requirements, similar to large drug manufacturers.

  • Most Popular VideosMost Popular VideosMore>>

  • Love Week Starts

    Love Week Starts

    One church in Roanoke is helping others get a head start on back to school supplies. About 25 volunteers packed 250 back packs full of pencils, notebooks and tissues for Straight Street.
    One church in Roanoke is helping others get a head start on back to school supplies. About 25 volunteers packed 250 back packs full of pencils, notebooks and tissues for Straight Street.
  • Confederate Flag Protest in Lexington

    Confederate Flag Protest in Lexington

    Organizers from the Sons of the Confederate Veterans held a rally in Lexington. This comes after the administration at Washington and Lee University recently decided to remove Confederate battle flags from Lee Chapel.
    Organizers from the Sons of the Confederate Veterans held a rally in Lexington. This comes after the administration at Washington and Lee University recently decided to remove Confederate battle flags from Lee Chapel.
  • Crash on Interstate 81 in Montgomery Co.

    Crash on Interstate 81 in Montgomery Co.

    We're told one person was transported by Lifeguard 10 to the hospital. The accident involved a tractor trailer and an ambulance. All lanes are now back open.
    We're told one person was transported by Lifeguard 10 to the hospital. The accident involved a tractor trailer and an ambulance. All lanes are now back open.

  • Most Popular StoriesMost Popular StoriesMore>>

  • DUI accident in Roanoke closes part of I-81 North

    DUI accident in Roanoke closes part of I-81 North

    DUI accident in Roanoke closes part of I-81 North

    Monday, July 28 2014 4:16 AM EDT2014-07-28 08:16:28 GMT
    ROANOKE (WSLS) - Part of Interstate 581 in Roanoke was shut down early this morning following what police say was a DUI crash.The accident happened around 3:10 a.m. Police say a man was driving a truck when he lost control and flipped.He was arrested for driving under the influence.All northbound lanes will be reopened to traffic momentarily.
    ROANOKE (WSLS) - Part of Interstate 581 in Roanoke was shut down early this morning following what police say was a DUI crash.The accident happened around 3:10 a.m. Police say a man was driving a truck when he lost control and flipped.He was arrested for driving under the influence.All northbound lanes will be reopened to traffic momentarily.
  • Prostitution sting nets 31 arrests

    Prostitution sting nets 31 arrests

    Tuesday, April 20 2010 11:21 PM EDT2010-04-21 03:21:00 GMT
    31 people are in trouble with the law after a three day prostitution sting in Richmond. Police told NBC12 they targeted specific areas where residents and business owners complained about the illegal activity.
  • Fugitive Friday: Central Virginia's Most Wanted

    Fugitive Friday: Central Virginia's Most Wanted

    Friday, July 25 2014 8:49 AM EDT2014-07-25 12:49:07 GMT
    Fugitive Fridays tracks down Central Virginia's most wanted. Take a look at the photos and see if you can help police track down these suspects.
    Fugitive Friday helps track down Central Virginia's Most Wanted.
Powered by WorldNow

WSLS 10, P.O. Box 10
Roanoke, VA 24022-0010

Telephone: 540.981.9110
Fax: 540.343.3157
Email: news@wsls.com

Can't find something?
Powered by WorldNow
All content © Copyright 2000 - 2014 Media General Communications Holdings, LLC. A Media General Company.