FDA Goes Head-to-Head With Uncooperative Compounders

FDA Goes Head-to-Head With Uncooperative Compounders

Posted By Golomb & Honik || 20-Oct-2014

Just this month, the FDA has been forced to ask yet another company to issue a recall for products which create significant safety risks to consumers due to sterility issues. The FDA issues between ten and thirty recalls each months, with about one per month for pharmaceutical drugs. According to an ABC news report in 2012, many believe the system in place for communicating these recalls may not sufficiently warn unsuspecting consumers. In fact, only about half of these recalls-those deemed the most serious, and known as Class I recalls-have official public notices issued.

Sterility Safety Issues Revealed

A Dallas compounding pharmacy is the target of the recent FDA mandate, which included an official public notice. NuVision Pharmacy, operated by Downing Labs, has received three FDA warnings over the past fifteen months regarding the safety of its compounded drugs. FDA officials are concerned that the medications from NuVision Pharmacy, which are currently in circulation, could be contaminated, presenting a significant safety risk of illness or injury. An inspection early this summer revealed a litany of problems associated with potential contamination.

The formal request letter sent by the FDA to Downing Labs and NuVision Pharmacy cites numerous manufacturing issues including:

  • Lack of scientific data supporting explanations for prior sterility failures
  • An inability to properly identify the reason for the failures
  • "Sterile" vials containing fibers and particles found by visual examination

NuVision Refuses to Comply with FDA Requests

The FDA issued two alerts last year regarding NuVisions's sterility problems, prompting NuVision to recall HcG 5000 IU compounds. The alert stated that " in the event a sterile product is compromised, patients are at risk for serious and possible life-threatening infections." Following the first alert, the FDA attempted (unsuccessfully) to persuade NuVision to recall additional products. NuVision essentially thumbed their noses at the FDA on their company website, stating they were not a drug manufacturer, therefore were not required to follow prescribed FDA manufacturing standards. Compounded drugs are not required to go through the FDA approval process, resulting in potential safety hazards to patients.

What is Compounding?

Compounding is a practice in which a pharmacist, physician (or a person under the supervision of a licensed pharmacist or physician) mixes, combines or alters the ingredients of a specific drug in order to specifically tailor the medication to a patient. Compounded drugs may be necessary when the health needs of a patient are unable to be met by an FDA-approved medication. An example would be a patient who was allergic to certain dyes typically used in a required medication. The compounding pharmacy would mix the drug without those dyes in order to avoid allergic reactions. An elderly patient who might be unable to swallow his or her medication in pill form could have it compounded as a liquid.

What Prompted the 2012 Drug Quality and Security Act?

In 2012, an outbreak of fungal meningitis causing dozens of deaths was tied to a compounded product, leading the FDA to ask Congress for legislation allowing the agency to bolster its regulatory oversight when dealing with noncompliant compounders. This request led to the Drug Quality and Security Act which created two classes of compounders-those who comply and those who refuse. The act requests that entities which compound sterile drugs register with the FDA as an outsourcing facility. This facility must meet certain conditions in order to be exempt from the FDCA's approval requirements.

Further, the drugs must be compounded under the direct supervision of a licensed pharmacist. The second group is comprised of those compounders who refuse to register with the FDA. The compounders who fail to register (such as NuVision) are still subject to warning letters, product seizures and the possibility of criminal violations for distribution contaminated products. Such uncooperative compounders may see revenues drop due to consumer worry about drug safety, while the FDA continues to struggle under insufficient resources which would allow them to offer the protection consumers want and deserve.

National Dangerous Drug Lawyers

If you or a loved one has suffered any serious side effects from the use of a compounded medication, you have a right to seek justice. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national class action lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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