FDA must continue to protect vulnerable patients

On June 21, the former owner of the New England Compounding Center (NECC), a compounding pharmacy based in the Boston area, will be sentenced after having been found guilty of fraud and racketeering. This is the end of a long saga that began in 2012, when a deadly meningitis outbreak that began at the unsanitary and unsafe facility at the NECC killed 60 people and sickened hundreds of others across the country. The tragedy drove consumer advocates and health experts, among others, to pressure Congress into action to increase the oversight and regulation of compounding pharmacies. Unfortunately, this smart, pro-consumer regulation is now at risk.

Compounding pharmacies have exploded in the United States in recent years: nearly 8,000 of them currently operate, altering medicines according to unique patient needs. Unfortunately, compounding pharmacies have been able to exploit a loophole in order to avoid much of the safety oversight that is required of other pharmaceutical manufacturers.

As one former U.S. Food and Drug Administration official has noted, “Although compounding is supposed to be performed under sanitary and otherwise appropriate conditions, the FDA exempted compounding pharmacies from many of the manufacturing, labeling and other requirements other drugs are subject to. Regulators acknowledge that compounded drugs pose a higher risk than FDA-approved drugs. Nevertheless, according to testimony by the federal government’s General Accounting Office before the Senate Health, Education, Labor and Pensions Committee in 2003, ‘Unlike drug manufacturers, who are required to report adverse events associated with the drugs they produce, FDA does not require pharmacies to report adverse events associated with compounded drugs.’”

This is of deep concern to our organization, the National Consumers League, where we have worked for more than 100 years with the belief that consumers should demand safety and reliability from the goods and services they buy. The growth of the compounding industry outside an overarching emphasis on consumer protections demands regulatory action. As I’ve noted in a previous column on the issue, “large-scale compounding pharmacies today are acting as quasi drug manufacturers… problems of health and safety for consumers have increased as well. … Compounding has been taken over by behemoth facilities churning out thousands of compound medications.”

In 2013, a bipartisan piece of legislation, the Drug Quality and Security Act, was passed, increasing FDA oversight of compounding facilities and limiting the amount of compounded medicines those pharmacies can make without first having received a doctor’s order. More regular inspections and stricter reporting requirements were put into place, all to the benefit of patients across America.

Unfortunately, compounding pharmacy industry lobbyists have been pressuring the Trump Administration to roll back these requirements to the detriment of patient safety. This simply cannot be allowed to happen. Patient safety is too important, and the regulatory demands of complying with the same requirements that other companies involved in the process of making drugs and handling prescriptions with integrity are perfectly reasonable to ask of this group of businesses.

In 2014, at a hospital in South Texas, 15 people were sickened, and two died from the bacteria Rhodococcus equi, “which typically infects horses and other grazing animals, and they all fell ill after infusions of the same drug, calcium gluconate,” according to USA Today. One compounding pharmacy 200 miles away was identified as the source of the problem, but its recall of the contaminated drug did nothing to bring the patients who had been killed back to life. These are preventable tragedies that should not be allowed to continue under our watch. The costs are simply too great.

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