Consumer Watchdog Asks FDA To Revisit Compounding Firms
WASHINGTON — A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded drugs.
Contaminated pain injections from a Massachusetts compounding pharmacy have been blamed for fungal meningitis that has killed 36 people and sickened more than 500, according to federal health officials.
More: U.S. Meningitis Outbreak
- 10/7/12: Mass. Pharmacy Linked To Meningitis Outbreak Issues Wide Recall
- 10/11: Mass. Pharmacy Industry Resists Call For Stricter Regulation
- 10/15: FDA: Pharmacy’s Other Drugs May Be Causing Illness
- 10/16: Former Regulator Calls For More Oversight Of Pharmacies
- 10/16: Criminal Investigators Visit Framingham Pharmacy
- 10/23: A Trail Of Complaints At Pharmacy Linked To Meningitis Deaths
- 10/24: State Moves To Revoke License Of Firm Tied To Outbreak
- 10/31: Sister Company Of Framingham Pharmacy Recalls Drugs
- 11/7: Mass. Pharmacy Board Director Is Fired
- 11/14: Sec. Bigby: Meningitis Outbreak A ‘Disaster’ That Was ‘Preventable’
- 11/28: In Outbreak Wake, Hospital Pharmacies Step Up Drug Compounding
- 1/4/13: Patrick Proposes New Compounding Pharmacy Rules
Complete Coverage: Meningitis Outbreak
In a letter to the FDA sent Thursday, Public Citizen asks the agency to revisit 16 compounding pharmacies that received warning letters from the agency between 2003 and 2012.
Compounding pharmacies traditionally mix customized medications based on doctors’ instructions, turning out a small number of specialized products for patients with unusual medical needs. However, some pharmacies have grown into much larger businesses in recent years.
Congressional investigators recently reported that the FDA inspected the New England Compounding Center three times before the outbreak, and issued the company a warning letter in 2006. The letter cited the company for several violations, including mass-producing drugs without doctors’ prescriptions and repackaging FDA-approved drugs into smaller doses.
Public Citizen notes that the agency often does not follow up on warning letters to see if the problems have been corrected.
“By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens,” said Dr. Michael Carome, deputy director of Public Citizen’s health unit, in a statement.
The consumer advocacy group wants the agency to follow up on warning letters issued to pharmacies in 15 states for a variety of violations, including:
- producing compounded drugs without a doctor’s prescription
- producing copies of drugs already approved by the FDA
- making drugs from non-FDA approved ingredients
Public Citizen notes that five of the warning letters, which are available on the agency’s website, identified injuries or deaths allegedly associated with the pharmacies’ products.