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How the FDA Continues to Fail Vulnerable Patients

August 19, 2020

August 19, 2020
By Naomi Lopez

For the first time in recent memory, the FDA is moving at a record pace to remove barriers and speed approval to provide treatment options and a vaccine for COVID-19. Unfortunately, some of its archaic and bureaucratic policies, which are magnified amid this crisis but often remain unseen by the public, are inflicting unnecessary harm and suffering on patients.

For example, look at the agency’s policies that restrict access to domperidone, a drug easily accessible around the world that is used to treat chronic stomach and bowel ailments for an estimated 5 million patients suffering from some form of gastroparesis. For some patients, like young Cassie Le, access to domperidone meant the difference between being able to eat by herself or forced onto a feeding tube just so that she could ingest and hold down food. For patients like Cassie, this was the treatment of last resort as no other drugs proved effective.

The FDA has made domperidone illegal to obtain, even with a physician’s prescription, without going through a costly and time-consuming “mother may I” process to get the government’s permission. Previously, domperidone had been readily available in the U.S. through compounding pharmacies and only required a prescription. But over the years, the FDA imposed import restrictions and compounding restrictions making it impossible to obtain.

In the midst of COVID, many gastroparesis patients are facing enormous uncertainty about their health and ability to carry on daily activities. One alternative drug that some patients rely on, Gaviscon liquid, is not readily available. Due to a labeling omission—failure to include the wording “Ask a doctor before use if you are on a magnesium-restricted diet”—the drug has been voluntarily pulled from the shelves by the manufacturer in order to comply with the FDA rules that require this language. (There are no documented cases of patient harm stemming from the magnesium contained in the product.) For many of these patients, there is no other alternative and interrupted treatment is debilitating and, for some, can become life-threatening.

As patients languish, it is important to understand the basis for these restrictions. Michael Smith, a leading gastroparesis patient advocate, described the odd events that led to the ban in a recent Patients Rising podcast (episode #25). The consumer group Public Citizen pushed to withdraw domperidone based on potential patient risk. Never mind that the drug had a decades-long safety profile, was available across the globe, and, even if there were some safety concerns, is no more dangerous than erythromycin, for example, which is widely available.

Smith has been engaged with his fellow advocates in a 15-year process to educate the FDA about his patient community’s medical needs and the acceptable medical risks many willingly consent to. Furthermore, trained and licensed healthcare providers should not be overridden by federal bureaucrats.

There is no doubt that this patient community values their providers having information about potential risks. But the FDA should not have slam the door shut on this treatment option—especially today when their own care is becoming increasingly difficult.

Goldwater Institute National Investigative Journalist Mark Flatten details the medical and resulting struggles these patients face in his report Sickening: FDA Bureaucracy Blocks Common “Miracle Drug.” That these patients are being subject to additional, unnecessary suffering in the name of patient safety is both disturbing and sad.

Instead of sitting idly by as these patients suffer, the FDA should restore the lifeline to domperidone for those patients whose physicians believe it is the best option for them. The FDA has a Risk Evaluation and Management Strategies (REMS) system that requires the reporting of adverse event and safety information for drugs that may be high-risk to patients.

The FDA should make every effort to make domperidone available to the patients whose doctors believe it offers the best treatment option. These decision treatments rightfully belong with patients and their doctors—and not driven by consumer advocates and federal bureaucrats who stand in their way.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.



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