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House Republicans Tell FDA: Meningitis Action Will Not Occur Without FDA Documents

Filed November 20th, 2012 admin

Congressional Republicans investigating the deadly fungal meningitis outbreak linked to tainted drugs produced by the New England Compounding Center (NECC) have told the U.S. Food and Drug Administration (FDA) not to expect any new action to limit future problems until the agency releases documents about its role in the current predicament.

The House of Representatives Energy and Commerce Committee’s Republican majority staff released a letter this week that gave the FDA until the end of November to comply with a document request first made in mid-October, Reuters said. The letter cited the need for the documents to identify any possible weaknesses in FDA’s regulatory system that can be corrected administratively or legislatively.

The FDA has asked lawmakers to clarify its authority to oversee large-scale drug compounding companies like NECC, which made the epidural steroid injections that have been linked to the fungal meningitis outbreak. The outbreak has now killed 34 people in 19 states and resulted in 490 reported illnesses, according to latest numbers released by the U.S. Centers for Disease Control and Prevention (CDC). Drug compounding is a practice in which pharmacists alter existing drugs to meet the needs of specific patients. Some compounders have transformed into large-scale producers that some experts say should be subject to FDA regulation, Reuters said.

Several House Democrats have called for Congressional action to clear up the situation before year end. However, at a Committee hearing last week, several Republicans charged that FDA already had the authority to avoid the outbreak but failed to act, despite repeated problems at the NECC, Reuters said.

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