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