Fungal meningitis outbreak raises questions about safety of compounding pharmacies

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by Jim Orr

Contaminated injections from a “compounding pharmacy” have been blamed for an outbreak of fungal meningitis that has killed 34 people and sickened 490. Congress recently summoned state and federal regulatory officials to answer questions in an effort to determine what went wrong.

The FDA regulates drug “manufacturers.” In theory, there should be a clear distinction between “compounding” and “manufacturing.” A compounding pharmacy makes customized prescription medications as prescribed by a physician, veterinarian or other prescribing practitioner. A drug manufacturer makes FDA-approved prescription drugs for mass markets in predetermined set strengths and dosage form. However, in today’s world, “compounding” is less likely to refer to your neighborhood pharmacist carefully measuring out a batch just for you than to a large, factory operation generating vast quantities of medication to be shipped around the country.

The FDA’s regulatory authority over compounding pharmacies is limited by law. Because of these limitations, compounded drugs are not FDA-approved for safety and efficacy, and compounding pharmacies are not generally required to tell the agency what products they are making. The FDA’s authority to inspect compounders’ records is also limited. Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary day-to-day oversight.

Although the FDA closely regulates drug “manufacturers,” oversight of compounding pharmacies has largely fallen to the states. However, the states have simply failed to keep pace with the expansion of the compounding pharmacy industry.

Unlike nearly every other state, Texas at least has a compounding pharmacy testing program. However, the Austin-American Statesmen has recently reported that budget cuts have meant fewer and fewer compounding pharmacies are actually being inspected in Texas. Dexheimer reports that in 2010, Texas conducted tests on medications compounded at 65 Texas pharmacies. The following year, the number dropped to 30. By the end of fiscal year 2012, in August, the number had plunged to only 21 — less than a third from only two years earlier. Money the agency spent on the testing program slid 72 percent over that time.

Testing fewer than two dozen pharmacies is “absolutely not” sufficient to protect patients, state Sen. Leticia Van de Putte (D-San Antonio), a licensed pharmacist who sponsored the bill authorizing state regulators to test mixed drug samples was reported as saying. “You just hope to God nothing goes wrong.”

Of course, as the recent outbreak of fungal meningitis caused by contaminated injectable steroids manufactured by New England Compounding Center makes too plain, things often do go wrong.

A long list of things going “wrong” at compounding pharmacies can be found in a report complied by the Office of Congressman Edward J. Markey of Massachussets. The report, “Compounding Pharmacies, Compounding Risk,” discusses the history of safety problems at compounding pharmacies as well as issues regarding the regulation of such pharmacies.

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers and pharmacies accountable and responsible for their actions. If you or a loved one has experienced the tragedy of losing a family member as a result of a delinquent pharmacy, drug manufacturer, compounding company or health care provider, you and your family deserve answers to your questions. If your loss was as a result of a defective drug or perhaps a physician’s negligence, you have the right to demand that the negligent drug company, pharmacist or physician be held responsible.

Contact the law firm of Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by filling out our free case evaluation form located on this page.