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Behind the Meningitis Outbreak: Pharmacies fought FDA regulation

At the heart of the tragedy is the compounderu2019s successful track record blocking FDA authority that could have averted the disaster.

Fifteen people have died and several hundred infected in an outbreak of meningitis contracted from contaminated spinal steroid injections. The numbers are growing and so is awareness of the growth of a little known corner of the pharmaceutical industry, called compounding pharmacies, which is responsible for the tragedy. “We’re nowhere near the end of this problem,” Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville told “CBS This Morning.”

The compounding pharmacies originally were supposed to provide customized medication for individual patients but have morphed into bulk manufacturers outside of FDA’s regulatory reach.

At the heart of the tragedy is the compounder’s successful track record blocking FDA authority that could have averted the disaster. Their efforts are a textbook model of industry opposition to new rules that could save lives. Their arguments are the same that the Chamber of Commerce and industry is using today to block clean air, workplace safety and financial industry protections and they are the same they’ve used to fight every existing health, safety, consumer and environmental protection we take for granted.

Unfortunately, the compounding pharmacies’ success in avoiding FDA oversight has led to tragedy for families.

In 1997, at the urging of regulators who were concerned that the compounders looked increasingly like mass producing pharmaceutical manufacturers, Congress passed a law that gave the FDA clearer authority to treat drug compounders like drug makers. Four people died from meningitis in 2001-02 after they received contaminated back pain shots. In 2002, the compounders sued and the US Supreme Court struck down the 1997 law.

In October 2003, the Senate Committee on Health, Education, Labor and Pensions held hearings in response to “a significant number of very real problems caused by compounded drugs.” Senator Christopher Bond reported that they had “received reports of nonsterile eye drops causing blindness, spinal injections contaminated with bacteria and/or fungus, resulting in hospitalization and, in some cases, death, and children poisoned as a result of pharmacy compounding errors.”

The industry testified – successfully – against FDA regulation.

Daniel A. Herbert, President, American Pharmacists Association urged the adoption of “voluntary, non-punitive” but not mandatory disclosure by pharmacists of the risks associated with compounded drugs.

A Congressional proposal to create an FDA advisory panel on compounding pharmacies was killed when the International Academy of Compounding Pharmacists (IACP) mobilized its 2700 members to target key lawmakers including Texas Congressman Tom Delay, whose district was home to IACP’s headquarters.

In 2007, Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.) proposed the Safe Compounding Drug Act to address the regulatory gaps.

The bi-partisan legislation would have given FDA authority to inspect compounding pharmacies, regulate interstate sales and focus compounding on the original purpose of providing individualized medications rather than becoming stealth mass production manufacturers that operated outside of FDA oversight.

Industry groups inundated Capitol Hill with all too familiar predictions of disaster and unintended consequences. The IACP warned that FDA regulation would put their industry “in jeopardy.”

They denied there was a problem that required federal regulation since “State boards of pharmacy have done a great job” according to L.D. King, executive director of IACP.

A letter from a coalition of nine pharmacy organizations claimed that the legislation would have unintended consequences and would “negatively impact patient access to necessary compounded prescription medications.”

IACP executive David Miller, told Reuters that the federal regulations would “strangle the industry.”

They warned of it would “create onerous (read: big government), new requirements”

And finally, they claimed they were taking care of the problem. In 2006, responding to earlier contaminations and deaths, the pharmacist groups created an industry-run voluntary accreditation process for compounders.

In the face of industry mobilization, Kennedy’s legislation never made it out of committee.

It is now clear that the compounders were wrong – tragically wrong.

The results are in and it’s clear that voluntary industry self-regulation doesn’t work. As of October 2012, only 162 of the thousands of these pharmacies have been accredited.

It’s clear that state level regulation isn’t enough. The compounding pharmacies are adept at maneuvering through the patchwork of regulatory peaks and valleys and state agencies charged with monitoring the pharmacies certainly simply aren’t doing the “great job” that industry claims.

Finally, the typical predictions of economic disaster for industry and for patients are simply unsubstantiated smokescreens intended to frighten policy makers and consumers.

The consequences of inaction aren’t idle speculation. Hundreds of people have become ill and too many have died from using contaminated compound medicines over the last fifteen years. Congressman Edward Markey (D-MA) is urging Congress to take quick action. Given their track record, compounders will likely use the same misleading rhetoric and ramp up their spending on lobbyists and campaign contributions to block new proposals to put them under FDA rules. The IACP has increased their lobbying spending from $20,000 in 2001 to $116,189 in 2011. Hopefully, Congress will finally realize that industry is crying wolf and take the step they should have taken fifteen years ago to close the regulatory loophole. If not, more lives will almost certainly be lost.

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