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Despite Deadly Outbreak, FDA Cannot Recall Drugs

Health Letter, March 2017

By Sarah Sorscher, J.D., M.P.H.

In January, the murder trial began for Barry J. Cadden, former pharmacist, president and co-owner of now-shuttered New England Compounding Center. Cadden was charged with second-degree murder for his role in producing contaminated drugs that led to a nationwide fatal fungal meningitis outbreak in 2012.

The 2012 outbreak, which sickened more than 778 patients and ultimately led to 76 deaths, spurred the Food and Drug Administration (FDA) to inspect compounding pharmacies and other sterile drug producers across the country.

The results are bleak.

A recent FDA report detailed unsanitary conditions at a majority of the inspected facilities, including dog beds and dog hairs close to a sterile compounding room, use of coffee filters to filter liquid drugs, and dead insects in ceilings. In many cases, the inspection led to a recall: the FDA reported that about 100 drug recalls have been issued, many for potentially contaminated drugs.

But more shocking is what happens when there is no recall.

Repeated alerts

A small but potentially dangerous cohort of drug producers has defied the FDA, refusing to recall potentially contaminated drugs in the face of repeated federal requests to do so.

One particularly egregious case, detailed in a September 2015 investigative piece by the Dallas News, involved a sterile drug producer in Dallas, Texas that originally operated under the name Apothécure. The company came under federal scrutiny in the mid-1990s, when FDA inspectors responding to reports of patient infections found mold growing in at least one drug made at the facility.

Over the next two decades, Apothécure was rocked by lawsuits, including a federal investigation of three patient deaths. Seeking a fresh start, owner Gary Osborn launched a new business, NuVision, in 2011 at the same location.

Regulators soon found their way back to NuVision after receiving reports of fever, flu-like symptoms, and other issues associated with NuVision drugs. Over the next two years, the owners engaged in a protracted battle with federal officials over problems at the facility.

An FDA inspection that concluded in April 2013 identified sterility assurance problems, prompting NuVision to issue a partial recall of certain injectable products because it could not confirm that they were sterile. The FDA remained concerned about additional sterile products that were not recalled, and in May the agency issued a press release warning health care providers not to use any of the sterile products produced by the company.

Months passed with no recall. In July 2013, the agency took the unusual step of sending a public letter to Downing Labs requesting an immediate recall of all sterile drug products. The letter proved ineffective, and the FDA posted another warning in August that year reminding health care providers not to use sterile products from NuVision.

In July 2014, FDA inspectors returned to NuVision, now operated by a former employee under the name Downing Labs. Yet again, inspectors found sanitary and sterility problems, this time involving multiple lots of contaminated sterile drugs. Unable to force a recall, the FDA posted yet another warning to health care providers, urging them to avoid the company’s products.

Insisting that any problems had been corrected, owners of Downing Labs requested that reports documenting quality control issues not be linked with the facility’s new name on the FDA’s website. Clearly unconvinced by these efforts, the agency issued another recall request and a press release that September, reminding health care providers yet again not to use the facility’s products, and again highlighting the repeated sterility failures from the July inspection.

The following September, just days after the Dallas News piece broadly publicized the new company’s sordid past, federal inspectors returned to Downing Labs and identified serious deficiencies, including evidence that the company had distributed drug products that failed sterility testing. At last, after more than two years and half a dozen requests and alerts from the FDA, Downing Labs initiated a nationwide recall of all sterile drug products in October 2015. The owners also agreed to close the facility down, ceasing all drug production.

Recall refusals a growing problem

If NuVision/Downing Labs had made vaccines, medical devices, infant formula, food or even tobacco, repeatedly defying the FDA’s recall requests would have been futile: The agency has the legal authority to force an immediate mandatory recall to cease the distribution for any of these products. But the FDA’s options are more limited when it comes to protecting the public from potentially hazardous drugs; it often has to settle for strongly worded requests, alerts and other inadequate measures when a company refuses to issue a voluntary recall.

NuVision’s initial refusal to issue a recall has now set a precedent, which is becoming a growing problem for the FDA. Since 2013, the agency has been forced to issue alerts in at least four other instances in which companies resisted carrying out a prompt nationwide recall of all sterile products.

While these drug producers often represented themselves as traditional compounding pharmacies making individually tailored medications, many were in fact distributing drugs on a wider, potentially more damaging scale. The FDA noted that two facilities, Medaus Inc. and Cape Apothecary, were manufacturing unapproved new and misbranded drugs in violation of the federal Food, Drug, and Cosmetics Act. Another facility, I.V. Specialty, had registered with the FDA as an outsourcing facility, a category of sterile drug makers permitted to manufacture drugs on a mass scale.

“Seek urgent medical care immediately”

And the problem is spreading beyond sterile drugs. In January, the FDA announced that it confirmed high levels of belladonna, a toxin, in homeopathic infant teething products that were meant to contain only trace amounts of the substance. Since 2006, the FDA has received more than 370 reports of adverse events, including infant hospitalizations and even deaths, involving the use of Hyland’s homeopathic teething products, as detailed in an investigative piece published by STAT on February 21. The manufacturer, Standard Homeopathic Company, insists that its products are safe and has refused to conduct a recall.

Lacking a means to force the company to pull the dangerous teething tablets from store shelves, the FDA continues to urge parents and caregivers not to give these products to children and to “seek urgent medical care immediately if their child experiences seizures, difficulty breathing,” or other side effects after using the company’s homeopathic teething products.

Safety not guaranteed

Most patients never encounter these FDA warnings after failed recall attempts. Instead, we mistakenly assume that the FDA will intervene to pull dangerous products from the market, keeping our drug supply safe.

But the FDA’s current tools are ill-suited to address urgent safety issues related to tainted drugs, leaving the agency with insufficient means to protect patients from potentially dangerous products that have already been distributed.

A proposal now before Congress, the Recall Unsafe Drugs Act of 2017 introduced by U.S. Rep. Rosa Delauro (D-Conn.), would address this problem by granting the agency the authority to order an immediate drug recall when a manufacturer refuses to act. Similar proposals have been considered in the past, but they have failed in part because there were no examples of companies resisting such a request before. That has now changed.

Congress should act to grant mandatory drug recall authority to the FDA before this growing problem leads to another major disease outbreak.