FDA Says it Cannot Control Compounding Pharmacies

The flurry of federal and state investigations into compounding pharmacies is leading to a consequent wave of drug recalls and reports of contaminations, and the FDA is saying that it can’t keep up. Contaminated drug lawyers, along with consumer advocates and healthcare professionals, refute that the agency can, and should, keep pace with facility inspection demands.

According to NBC News, the FDA has inspected more than 30 compounding pharmacies in the past two months, and a spokesperson for the agency acknowledged that there are numerous other facilities the agency is keeping an eye on. Those recent inspections resulted in three recalls since the outbreak of fungal meningitis in 2012. The outbreak, stemming from contaminated steroids manufactured at the New England Compounding Center (NECC), killed 51 people and sickened over 700 more, and many are saying the conditions at NECC are anything but rare.

There are more than 7,000 compounding pharmacies in the United States, which are licensed and overseen by individual state’s health departments. In addition to the NECC, at least four other compounding pharmacies have recently received warning letters or shut-down notices for their unsterile and dangerous facilities. These are Pallimed Solutions, Clinical Specialties, Med Prep, and Medi-Fare Drug and Home Health Center.

The last facility, Medi-Fare, recently received a letter from the FDA warning that its products did not match its prescriptions, and that it had serious deficiencies in sterile drug manufacturing processes. Any deviations from the government-regulated sterile drug process leave significant potential for contamination, which would put patients throughout the country at risk.

One doctor of the consumer group Public Citizen stated that, though the FDA appears to have authority to influence the actions of these facilities, we will just have to wait and see if it will stand behind the warning letters and violation notices. He went on to say that, previously, the FDA has failed to stand behind its actions; however, the seriousness of these contaminations could mean the agency is finally ready to follow through.

Compounding pharmacies are intended to mix prescriptions on an individual-patient basis, to fulfill certain specifications that large drug companies cannot. There is so much demand for such specific medications, however, that hundreds of these facilities are now manufacturing products on a larger scale. Some of them are starting to resemble large drug companies, but without having to adhere to the same strict regulations and sterility requirements.

This is resulting in dangerous and even deadly contaminations, such as the one found in magnesium sulfate IV solutions in March 2013 from New Jersey’s Med Prep Consulting. A nurse at a Connecticut hospital spotted visible particles of mold in the solutions, leading the company to recall all of its products. The FDA sent warning letters to Med Prep about its sterility practices twice previously, in 2001 and 2010, but apparently took no further action until the mold was found.

The Massachusetts state health board – which was responsible for the oversight of NECC – recently shut down Pallimed Solutions and recalled 16 of its products after inspectors found its facility to be unsterile. Again in March 2013, Georgia’s Clinical Specialties recalled all of its products after at least five people suffered serious eye infections from its injection drugs.

The FDA commissioner, Dr. Margaret Hamburg, recently asked Congress for explicit power to regulate the compounding pharmacies that are manufacturing drugs on a large scale. She stated that numerous facilities have not been cooperating with the agency, refusing to let it examine facilities and creating complex legal barriers to prevent them from doing so.

Undoubtedly though, no company would want to go through what the NECC has since the fungal meningitis outbreak. The company recently filed for bankruptcy, and is facing hundreds of lawsuits in addition to criminal prosecution. More than 14,000 patients received contaminated injections, and physicians are still on the lookout for more meningitis infections. Officials at the CDC noted that it has never seen any deadly contamination like this come from facilities regulated as drug manufacturers.

Dangerous drug lawyers at Pintas & Mullins Law Firm urge American patients, particularly those who receive specialized prescriptions, to keep up with the news surrounding compounding pharmacies. If you believe you were injured from a contaminated or recalled drug, you have important legal rights, and may be eligible for significant compensation for any lost wages, medical bills, and pain and suffering.