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US nears new curbs on compounding pharmacies

Spurred by crisis in Massachusetts

WASHINGTON — The Senate cleared a key hurdle Tuesday for a bill intended to reduce the chance of another public health tragedy like last year’s shipment of contaminated drugs by a Massachusetts pharmacy, which caused an outbreak of fungal meningitis that killed 64 people.

The measure to increase oversight of compounding pharmacies — which operate like drug manufacturers but have been regulated loosely — is expected to reach President Obama’s desk this week, once the Senate takes a final vote.

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The legislation is the official response to a year of grieving, confusion, and anger, after hundreds of people in 23 states who received steroid injections for back and joint pain came down with mysterious maladies. In addition to the deaths, 751 people were infected. Others continue to experience debilitating symptoms, including fatigue, rashes, and headaches.

Doctors and public health sleuths eventually traced the origin of their suffering to a pharmacy in Framingham, the New England Compounding Center, that acted like a large-scale drug manufacturer but was treated under the law like a mom and pop pharmacy, regulated by the state. The steroid vials had been infected by mold in the New England Compounding Center facility, authorities said.

The episode revealed large gaps in the system of ensuring drug safety and drew attention to the entire class of firms like the New England Compounding Center, known as a compounding pharmacies. Some critics say the bill does not go far enough to ensure stronger enforcement by the Food and Drug Administration and still relies too heavily on state inspectors. But lawmakers said they were taking a strong step to protect patients.

“It’s just beyond all comprehension how many people got sick and died,” Senator Tom Harkin, an Iowa Democrat and one of the bill’s lead sponsors, said from the Senate floor Tuesday. “I’m sorry it took a terrible calamity like the outbreak of meningitis to get us to really focus on this and move it, but it did.”

The bill is intended to give the FDA clearer power to regulate these compounding pharmacies, which mix, package, and ship drugs. The measure also provides a voluntary system for further oversight of the industry.

Tuesday’s procedural vote in the Senate was the most significant test, requiring a 60-vote majority. It passed, 97 to 1. The House has already approved the measure.

The legislation’s Republican co-sponsor, Senator Lamar Alexander, who represents Tennessee, one of the states hit hardest by the outbreak with 16 deaths, said the bill will not guarantee “there will never, ever be a tragedy again.” But in addition to preventing some future episodes, it draws a clearer line of responsibility for tainted drugs, he said.

As the size of last year’s outbreak grew, many people were outraged by the apparent gray area in the nation’s drug safety laws.

“The reason my father died was just pure negligence and greed,” Karen Talbott, whose 78-year-old father, Eddie Lovelace, a circuit court judge in Kentucky, died after a steroid injection, said Tuesday by phone. “My family feels really strong about this. There needs to be tougher regulations.”

The FDA had argued that its own policing powers over compounding pharmacies were vague, because of an adverse court ruling, though critics said the agency had failed to exercise its authority. Tuesday’s legislation will make sure the agency can continue the inspections of larger manufacturers that began after the outbreak was discovered, and have revealed further problems with the industry.

“For the first time, hospitals and health care facilities will have access to safer compounded drugs that are subject to rigorous FDA standards and oversight,” Senator Edward J. Markey said in a statement. Markey, whose former House district included the New England Compounding Center, has been a vocal critic of the industry, leading investigations and helping to draft the bill when he served in the House this year.

Last year’s fungal meningitis outbreak also sparked a new crackdown at the state level, with the Massachusetts House and Senate each passing separate bills last month aimed at policing compounding pharmacies. Provisions include online safety records and surprise safety inspections for compounding firms.

In addition to increasing regulation of pharmacies, the bill creates an electronic system to track the production history of every bottle of drugs sold in the United States, to prevent counterfeiting and speed up recalls of tainted drugs.

Several major consumer groups support the proposed federal measure, but critics say it will not do enough to prevent future outbreaks. Notably, the bill depends on compounding pharmacies to voluntarily submit to enhanced regulation from the FDA by registering themselves as “outsourcing facilities.” The original Senate bill had made that mandatory for much of the industry.

“The issue with all these deaths and infections is too important to leave it to voluntary registrations by these companies,” said Dr. Sidney M. Wolfe, senior adviser to the health research group at Public Citizen, which lobbied for tight regulations. “It takes serious measures to do something about it, and this legislation is not a serious measure.”

Even the compounding industry’s lobby is skeptical the legislation would prevent another episode like the one at the New England Compounding Center.

“Would NECC, with its alleged myriad violations of law and regulations, have voluntarily enrolled in this new category? We think the answer is clear,” David G. Miller, chief operating officer of the International Academy of Compounding Pharmacists, said in a statement.

By voluntarily registering, the firms will agree to more frequent and rigorous inspections and follow new safety standards and reporting requirements, similar to traditional manufacturers.

“No one has to register. It’s voluntary,” said Allan Coukell, a pharmacists drug safety specialist for the Pew Charitable Trusts, which lobbied on the bill and supports it. “Its success will depend on hospitals and clinics driving the market by deciding to purchase drugs from FDA-approved facilities.”

Still, that could leave thousands of pharmacies that produce at least some compounded drugs with scant federal oversight. The authors of the bill expect those pharmacies to be regulated primarily by the states.

“The FDA has certain inspection authority at the state level but they don’t have inspection authority of taking records from the pharmacy and taking samples, and that was something that the FDA specifically asked for,” said Sarah Sellers, a drug safety specialist who has consulted Congress and now consults for large pharmaceutical companies that compete with compounding firms and agrees that is a hole in the new measure.

But Sellers said the bill will nonetheless vastly improve oversight of large compounding pharmacies. She believes most, if not all, will register, and that identifying more responsibilities for state inspectors will improve enforcement.

“It’s very important that the states be involved because they really are on the front lines,” she said.

Globe correspondent Mattias Gugel contributed to this report. Noah Bierman can be reached at nbierman@globe.com. Follow him on Twitter @noahbierman.
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