Quantcast
Get breaking news alerts via email

Click here to manage your alerts
FILE - In this Wednesday, April 10, 2013 file photo, Food and Drug Administration (FDA) Commissioner Margaret Hamburg, foreground, with Health and Human Services Secretary Kathleen Sebelius, left, and others, speaks during a news conference at the Health and Humans Services (HHS) Department in Washington, to discuss the Health Department's fiscal 2014 budget. The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. In a blog post to the FDA's website Thursday, April 11, Hamburg noted that four pharmacies initially refused to admit the agency's inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections. (AP Photo/Manuel Balce Ceneta, File)
FDA finds safety issues at specialty pharmacies
First Published Apr 12 2013 10:29 am • Last Updated Apr 12 2013 10:29 am

WASHINGTON • The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs.

The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats.

Join the Discussion
Post a Comment

The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.

The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the New England Compounding Center, a Massachusetts pharmacy. The company’s injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer.

Compounding pharmacies are supposed to mix customized prescriptions based on individual doctors’ instructions. However, some pharmacies like the New England Compounding Center have grown into larger businesses, supplying bulk quantities of injectable drugs to hospitals across the country.

The FDA has stepped up its oversight of the pharmacies since the outbreak was identified in September, but agency officials say they have been slowed by the complex overlap of various state and federal laws that govern the industry. Pharmacies are licensed and overseen by state pharmacy boards, though the FDA sometimes intervenes when major safety issues arise.

In a blog post to the FDA’s website Thursday, FDA Commissioner Margaret Hamburg noted that four pharmacies initially refused to admit the agency’s inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections.

"These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health," Hamburg stated.

Hamburg has asked Congress to pass new laws giving the FDA explicit oversight over large compounding pharmacies. Under the proposal, large compounders would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers.

But the FDA proposal has faced pushback from some members of Congress, particularly House Republicans, who have been investigating whether the FDA could have prevented the meningitis outbreak using its existing powers.


story continues below
story continues below

The House Energy and Commerce Subcommittee for Oversight and Investigations will hold its second hearing on the issue next Tuesday. Hamburg is scheduled to testify, according to committee staffers.



Copyright 2014 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Top Reader Comments Read All Comments Post a Comment
Click here to read all comments   Click here to post a comment


About Reader Comments


Reader comments on sltrib.com are the opinions of the writer, not The Salt Lake Tribune. We will delete comments containing obscenities, personal attacks and inappropriate or offensive remarks. Flagrant or repeat violators will be banned. If you see an objectionable comment, please alert us by clicking the arrow on the upper right side of the comment and selecting "Flag comment as inappropriate". If you've recently registered with Disqus or aren't seeing your comments immediately, you may need to verify your email address. To do so, visit disqus.com/account.
See more about comments here.
Staying Connected
Videos
Jobs
Contests and Promotions
  • Search Obituaries
  • Place an Obituary

  • Search Cars
  • Search Homes
  • Search Jobs
  • Search Marketplace
  • Search Legal Notices

  • Other Services
  • Advertise With Us
  • Subscribe to the Newspaper
  • Access your e-Edition
  • Frequently Asked Questions
  • Contact a newsroom staff member
  • Access the Trib Archives
  • Privacy Policy
  • Missing your paper? Need to place your paper on vacation hold? For this and any other subscription related needs, click here or call 801.204.6100.